Data / Medical devices / United States / Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 182 510(k) clearances
Intuitive Surgical, Inc. is registered with the FDA (registration 3001675293) in Sunnyvale, CA, United States. It lists 26 device types. The FDA files 182 510(k) clearances under its listings, the newest dated October 14, 2026. 122 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3001675293
- Address
- 1266 Kifer Road, Sunnyvale, CA, United States, 94086
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- January 6, 1998
- Registered through
- 2027
- Brand names listed
- 10-12mm+Stapler Cannula Seal, 12 Mm & Stapler Bladeless Obturator, 12 mm Assist Cannula, 12 mm Blunt Obturator, da Vinci S, Si, 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si, 12 mm Endoscope Cannula Mount, Balloon Port, 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci, 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 182.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 14, 2026 | K262455 | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 8, 2026 | K261823 | da Vinci Surgical System, Model IS5000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 7, 2026 | K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | FDS | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 31, 2026 | K261824 | da Vinci Surgical System, Model IS5000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 14, 2026 | K261249 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 22, 2026 | K260695 | da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| March 11, 2026 | K253986 | da Vinci Force Feedback Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 24, 2026 | K253978 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 16, 2026 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 16, 2026 | K251739 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 16, 2025 | K251763 | IRISeg | QIH | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 15, 2025 | K252675 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 2, 2025 | K252069 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 3, 2025 | K251426 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 23, 2025 | K252045 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 10, 2025 | K251817 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 8, 2025 | K251227 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 5, 2025 | K252528 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 29, 2025 | K251324 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 28, 2025 | K252350 | da Vinci SP Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 29, 2025 | K250442 | da Vinci Surgical System, IS5000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 23, 2025 | K251213 | Da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 16, 2025 | K251202 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 2, 2025 | K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 13, 2025 | K250674 | Vessel Sealer Curved (480522) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 11, 2025 | K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 13, 2025 | K250786 | SP Endoscope, 0° (430600) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 24, 2025 | K243714 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 1, 2025 | K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 10, 2025 | K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | GAG | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 28, 2025 | K243582 | da Vinci SP Advanced Access Port Kit (432701) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 16, 2024 | K243641 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 10, 2024 | K242461 | IRISeg | QIH | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 26, 2024 | K242318 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 18, 2024 | K241814 | da Vinci SP Instruments (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 24, 2024 | K242070 | Ion Endoluminal System (IF 1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 10, 2024 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 28, 2024 | K241913 | da Vinci Handheld Camera | GCJ | Substantially Equivalent | Intuitive Surgical Operations, Inc. | accessdata.fda.gov |
| August 5, 2024 | K241635 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| August 5, 2024 | K241360 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 2, 2024 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| July 8, 2024 | K240502 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 3, 2024 | K241284 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 4, 2024 | K232773 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 24, 2024 | K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| April 3, 2024 | K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 14, 2024 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 18, 2023 | K232984 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 8, 2023 | K231798 | da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 5, 2023 | K231358 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 21, 2023 | K231212 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| May 12, 2023 | K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 5, 2023 | K230033 | Da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 16, 2023 | K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 28, 2022 | K223039 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| November 22, 2022 | K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 20, 2022 | K222827 | da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 15, 2022 | K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 16, 2022 | K220299 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 17, 2022 | K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 31, 2022 | K220023 | 8mm Monopolar Curved Scissors | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 10, 2021 | K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 23, 2021 | K212101 | da Vinci SP Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 29, 2021 | K212747 | Da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 26, 2021 | K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 6, 2021 | K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 23, 2021 | K211316 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 23, 2021 | K211595 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 26, 2021 | K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 10, 2021 | K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 22, 2020 | K202968 | Da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 10, 2020 | K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 16, 2020 | K202370 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 12, 2020 | K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 28, 2020 | K192717 | da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 26, 2020 | K201146 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 29, 2020 | K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| March 31, 2020 | K183086 | da Vinci X and Xi Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 6, 2020 | K191529 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| November 26, 2019 | K192367 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 14, 2019 | K191280 | E-100 Electrosurgical Generator, SynchroSeal | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 26, 2019 | K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| July 12, 2019 | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 6, 2019 | K191043 | da Vinci Handheld Camera | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 14, 2019 | K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 22, 2019 | K182643 | IRIS 1.0 System | LLZ | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| February 14, 2019 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | EOQ | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| February 1, 2019 | K183139 | Endoscope Sterilization Tray | KCT | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 18, 2019 | K183224 | SureForm 45, SureForm 45 Reloads | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| December 11, 2018 | K183107 | Intuitive Surgical Vessel Sealer Extend | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 24, 2018 | K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 28, 2018 | K180964 | Endoscope Sterilization Tray | KCT | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 7, 2018 | K180351 | EndoWrist Mercury Bipolar Grasper | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181395 | Universal Cannula Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 19, 2018 | K173585 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 5, 2018 | K173721 | SureForm 60 and SureForm 60 Reloads | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| May 31, 2018 | K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 31, 2018 | K173415 | EndoWrist 5mm Thoracic Grasper | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 26, 2018 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 23, 2018 | K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 122.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 24, 2026 | 98569 | Class II | Ongoing | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope. | accessdata.fda.gov |
| April 22, 2026 | 98701 | Class II | Ongoing | Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient ti | accessdata.fda.gov |
| April 2, 2026 | 98564 | Class II | Ongoing | Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three | Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. | accessdata.fda.gov |
| March 11, 2026 | 98525 | Class I | Ongoing | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | accessdata.fda.gov |
| December 30, 2025 | 98205 | Class II | Ongoing | da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; m | accessdata.fda.gov |
| December 15, 2025 | 98187 | Class II | Ongoing | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box) | Access Port System tray may develop cracks potentially resulting in a sterility breach. | accessdata.fda.gov |
| December 9, 2025 | 98408 | Class II | Ongoing | Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | accessdata.fda.gov |
| December 9, 2025 | 98383 | Class II | Ongoing | Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instr | Due to increased complaints for broken/frayed grip cables for reusable instruments. | accessdata.fda.gov |
| December 4, 2025 | 98215 | Class II | Ongoing | Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally in | Due to probe bags that may have a compromised or incomplete sterile pouch seal. | accessdata.fda.gov |
| November 17, 2025 | 98200 | Class II | Ongoing | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. | An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor. | accessdata.fda.gov |
| November 7, 2025 | 98050 | Class II | Ongoing | Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 s | Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction | accessdata.fda.gov |
| May 12, 2025 | 98890 | Class II | Ongoing | da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 | Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall. | accessdata.fda.gov |
| February 26, 2025 | 96345 | Class II | Ongoing | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A. Refer to HHE for additional details. Component: N/A | Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed | accessdata.fda.gov |
| December 19, 2024 | 95939 | Class II | Ongoing | 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue. | Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments | accessdata.fda.gov |
| December 19, 2024 | 95938 | Class II | Ongoing | 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | accessdata.fda.gov |
| August 21, 2024 | 98048 | Class II | Ongoing | da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 | Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may l | accessdata.fda.gov |
| July 12, 2024 | 95046 | Class II | Ongoing | Ion Endoluminal System, REF: 380748-65 | There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways. | accessdata.fda.gov |
| March 13, 2024 | 94252 | Class II | Ongoing | Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 | Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient. | accessdata.fda.gov |
| October 6, 2023 | 93301 | Class II | Ongoing | Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm | There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement. | accessdata.fda.gov |
| June 12, 2023 | 92418 | Class II | Ongoing | da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 | Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected. | accessdata.fda.gov |
| February 10, 2023 | 91503 | Class II | Ongoing | da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 | Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications. | accessdata.fda.gov |
| January 24, 2023 | 91505 | Class II | Ongoing | Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, RE | Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury. | accessdata.fda.gov |
| October 7, 2022 | 91080 | Class II | Ongoing | INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4- | Potential staple deployment failure and device fragment generation | accessdata.fda.gov |
| September 20, 2022 | 90826 | Class II | Ongoing | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS) | Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, re | accessdata.fda.gov |
| July 1, 2022 | 90332 | Class II | Ongoing | Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003 | Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system. | accessdata.fda.gov |
| June 22, 2022 | 90452 | Class II | Completed | The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions o | Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems. | accessdata.fda.gov |
| March 17, 2022 | 89736 | Class II | Ongoing | da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460 | As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s e | accessdata.fda.gov |
| March 3, 2022 | 89641 | Class II | Completed | VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422 | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. | accessdata.fda.gov |
| December 23, 2021 | 89274 | Class II | Ongoing | da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 | Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel o | accessdata.fda.gov |
| September 22, 2021 | 89109 | Class II | Ongoing | da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 | Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor dela | accessdata.fda.gov |
| September 21, 2021 | 88783 | Class II | Terminated | The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of | Incorrect expiration date on its package labeling (shipper box and inner carton label). | accessdata.fda.gov |
| August 6, 2021 | 88524 | Class II | Terminated | Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978 | Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. | accessdata.fda.gov |
| October 23, 2020 | 86664 | Class II | Terminated | Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endolum | The distal tip ring of the fully articulating catheter may become dislodged during the procedure. | accessdata.fda.gov |
| June 10, 2020 | 85822 | Class II | Ongoing | Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845. | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System. | accessdata.fda.gov |
| December 19, 2019 | 85556 | Class II | Terminated | STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach. | Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes. | accessdata.fda.gov |
| August 19, 2019 | 85324 | Class II | Ongoing | da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. | Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue t | accessdata.fda.gov |
| July 26, 2019 | 84335 | Class II | Terminated | da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures. | The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system. | accessdata.fda.gov |
| July 1, 2019 | 85256 | Class II | Ongoing | daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, | The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention. | accessdata.fda.gov |
| June 17, 2019 | 84963 | Class II | Terminated | da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an en | One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images. | accessdata.fda.gov |
| April 11, 2019 | 83482 | Class II | Terminated | da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart | Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking. | accessdata.fda.gov |
| April 1, 2019 | 85293 | Class II | Terminated | da Vinci SP surgical system | Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND | accessdata.fda.gov |
| January 16, 2019 | 81972 | Class II | Ongoing | daVinci Harmonic ACE Curved Shears | During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility. | accessdata.fda.gov |
| December 4, 2018 | 83994 | Class II | Terminated | Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298 | This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console. | accessdata.fda.gov |
| November 21, 2018 | 84023 | Class II | Terminated | da Vinci Xi Surgical System | Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery. | accessdata.fda.gov |
| October 25, 2018 | 83503 | Class II | Terminated | da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch | The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier. | accessdata.fda.gov |
| October 23, 2018 | 83192 | Class II | Terminated | The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary fu | The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly. | accessdata.fda.gov |
| August 15, 2018 | 80696 | Class II | Ongoing | da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipul | Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient. | accessdata.fda.gov |
| July 16, 2018 | 80947 | Class II | Terminated | da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist i | Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use. | accessdata.fda.gov |
| June 4, 2018 | 81073 | Class II | Ongoing | EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery. | The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation. | accessdata.fda.gov |
| May 17, 2018 | 80691 | Class II | Ongoing | The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16. | An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope. | accessdata.fda.gov |
| April 23, 2018 | 80318 | Class II | Terminated | da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box. | Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired. | accessdata.fda.gov |
| March 7, 2018 | 80249 | Class II | Terminated | da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Sur | Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component. | accessdata.fda.gov |
| September 19, 2017 | 78908 | Class II | Terminated | daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used wit | Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to m | accessdata.fda.gov |
| June 1, 2017 | 77389 | Class II | Terminated | da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors du | da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms. | accessdata.fda.gov |
| March 31, 2017 | 76911 | Class II | Terminated | da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist Suction Irrigator is designed to be used | Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm. | accessdata.fda.gov |
| March 15, 2017 | 76754 | Class II | Terminated | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapl | Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool. | accessdata.fda.gov |
| October 5, 2016 | 75473 | Class II | Terminated | da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to | Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances | accessdata.fda.gov |
| July 14, 2016 | 74811 | Class II | Terminated | STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgic | Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening. | accessdata.fda.gov |
| July 14, 2016 | 74705 | Class II | Terminated | STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgic | An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend | accessdata.fda.gov |
| May 9, 2016 | 74188 | Class II | Terminated | SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula. When attach | Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure. | accessdata.fda.gov |
| March 25, 2016 | 73736 | Class II | Terminated | EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS40 | Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use. | accessdata.fda.gov |
| March 16, 2016 | 73649 | Class II | Terminated | da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive | Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes. | accessdata.fda.gov |
| February 16, 2016 | 73314 | Class II | Terminated | da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be em | accessdata.fda.gov | |
| November 23, 2015 | 72776 | Class II | Terminated | 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the sy | This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources. | accessdata.fda.gov |
| September 9, 2015 | 72158 | Class II | Terminated | Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is in | B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks. | accessdata.fda.gov |
| August 17, 2015 | 72026 | Class II | Terminated | da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended | Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software. | accessdata.fda.gov |
| August 8, 2015 | 72036 | Class II | Terminated | Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si | In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. | accessdata.fda.gov |
| June 16, 2015 | 71448 | Class II | Terminated | INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate co | Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error. | accessdata.fda.gov |
| May 21, 2015 | 71285 | Class II | Terminated | Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping. | The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient. | accessdata.fda.gov |
| March 16, 2015 | 70777 | Class II | Terminated | da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. | accessdata.fda.gov |
| March 3, 2015 | 70705 | Class II | Terminated | da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intend | Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. | accessdata.fda.gov |
| February 16, 2015 | 70441 | Class II | Terminated | Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of t | There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface. | accessdata.fda.gov |
| February 11, 2015 | 70467 | Class II | Terminated | EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical Syste | Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws. | accessdata.fda.gov |
| January 21, 2015 | 70275 | Class II | Terminated | HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is use | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips. | accessdata.fda.gov |
| January 15, 2015 | 70181 | Class II | Terminated | da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. | The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time. | accessdata.fda.gov |
| December 5, 2014 | 69902 | Class II | Terminated | IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical | Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening. | accessdata.fda.gov |
| November 21, 2014 | 69845 | Class II | Terminated | Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci S | The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence. | accessdata.fda.gov |
| November 3, 2014 | 69638 | Class II | Terminated | 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. | Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument. | accessdata.fda.gov |
| September 18, 2014 | 69283 | Class II | Terminated | EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the acc | Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue. | accessdata.fda.gov |
| September 17, 2014 | 69270 | Class II | Terminated | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the E | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System. | accessdata.fda.gov |
| September 11, 2014 | 69213 | Class II | Terminated | ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in t | Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart. | accessdata.fda.gov |
| June 13, 2014 | 68553 | Class II | Terminated | Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086 | Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories.. | accessdata.fda.gov |
| June 11, 2014 | 68531 | Class II | Terminated | IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc. | In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue | accessdata.fda.gov |
| June 2, 2014 | 68814 | Class II | Terminated | EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, tr | Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is define | accessdata.fda.gov |
| May 21, 2014 | 68472 | Class II | Terminated | System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. | accessdata.fda.gov |
| May 9, 2014 | 68358 | Class II | Terminated | Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over t | Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system. | accessdata.fda.gov |
| March 13, 2014 | 67758 | Class II | Terminated | 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use. | accessdata.fda.gov |
| November 15, 2013 | 66918 | Class II | Terminated | Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and elect | Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. | accessdata.fda.gov |
| November 11, 2013 | 66866 | Class II | Terminated | Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitiv | Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance. | accessdata.fda.gov |
| October 21, 2013 | 66570 | Class III | Terminated | da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the | Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors. | accessdata.fda.gov |
| October 2, 2013 | 66524 | Class II | Terminated | Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for u | A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions. | accessdata.fda.gov |
| June 8, 2013 | 65590 | Class II | Terminated | da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuit | Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. | accessdata.fda.gov |
| May 8, 2013 | 65216 | Class II | Terminated | 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a | Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury. | accessdata.fda.gov |
| May 8, 2013 | 65194 | Class II | Terminated | 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. | Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. | accessdata.fda.gov |
| May 6, 2013 | 65168 | Class II | Terminated | da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments | Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262). | accessdata.fda.gov |
| March 15, 2013 | 64755 | Class II | Terminated | IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination. | Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation. | accessdata.fda.gov |
| January 24, 2013 | 65094 | Class II | Terminated | User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Rep | Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use. | accessdata.fda.gov |
| August 9, 2012 | 62807 | Class II | Terminated | Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Sc | There is potential for the sterility of the product to be compromised. | accessdata.fda.gov |
| July 13, 2012 | 62553 | Class II | Terminated | INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci S | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. | accessdata.fda.gov |
| April 27, 2012 | 68593 | Class II | Terminated | Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086 | Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. | accessdata.fda.gov |
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Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.