Data / Medical devices / United States / Cook Incorporated
Cook Incorporated: FDA-registered device maker in Bloomington, IN, United States, 334 510(k) clearances and 4 PMA approvals
Cook Incorporated is registered with the FDA (registration 1820334) in Bloomington, IN, United States. It lists 202 device types. The FDA files 334 510(k) clearances and 4 PMA approvals under its listings, the newest dated March 25, 2024. 95 recall events name it as the recalling firm (14 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1820334
- Address
- 750 Daniels Way, Bloomington, IN, United States, 47404
- Owner or operator
- COOK, INC. (1820334)
- Roles
- Complaint file establishment, Contract sterilizer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 31, 1977
- Registered through
- 2026
- Brand names listed
- 1,4 Layer Tissue Graft, ACROBAT 2 CALIBRATED TIP WIRE GUIDE, ACROBAT CALIBRATED TIP WIRE GUIDE, AQ HYDROPHILIC COATED DILATOR, AQ Hydrophilic Dual Lumen Ureteral Access Catheter, Advance Biliary Balloon Catheter, Advance, 14LP Low Profile PTA Balloon Dilatation Catheter, Aintree Intubation Catheter with Rapi-Fit Adapter 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 334.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2024 | K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | DYB | Substantially Equivalent | Cook Medical | accessdata.fda.gov |
| March 8, 2024 | K233177 | Nest VT Vitrification Device | MQK | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 16, 2023 | K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | MMX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 28, 2022 | K223098 | Bakri Essential Postpartum Balloon | OQY | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 6, 2021 | K210734 | Endovascular Dilator and Sets | DRE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 16, 2021 | K203670 | Extra Large Check-Flo Introducer | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 29, 2020 | K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | LJE | Unknown | Cook Incorporated | accessdata.fda.gov |
| December 16, 2019 | K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | LJE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 12, 2019 | K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set | JOH | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 12, 2019 | K191163 | Lumax Guiding Catheter | DQY | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 11, 2019 | K190084 | McLean-Ring Enteral Feeding Tube Set | KNT | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 5, 2019 | K183323 | UPJ Occlusion Balloon Catheter | EYB | Unknown | Cook Incorporated | accessdata.fda.gov |
| July 22, 2019 | K182985 | Roadrunner PC Wire Guide, Olcott Torque Device | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 16, 2019 | K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | LJE | Unknown | Cook Incorporated | accessdata.fda.gov |
| June 26, 2019 | K191485 | Deflectable Brush Biopsy Set | FDX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 26, 2019 | K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | KGC | Unknown | Cook Incorporated | accessdata.fda.gov |
| June 17, 2019 | K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | EYB | Unknown | Cook Incorporated | accessdata.fda.gov |
| May 29, 2019 | K182403 | Peel-Away Introducer | FED | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 17, 2019 | K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 17, 2019 | K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | LJE | Unknown | Cook Incorporated | accessdata.fda.gov |
| May 17, 2019 | K182252 | Cook Unimpregnated Central Venous Catheter | FOZ | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 1, 2019 | K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set | FDX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 25, 2019 | K182071 | Multi-Sideport Catheter Infusion Set | KRA | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 23, 2019 | K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | FAD | Unknown | Cook Incorporated | accessdata.fda.gov |
| March 29, 2019 | K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 27, 2019 | K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | LJE | Unknown | Cook Incorporated | accessdata.fda.gov |
| March 22, 2019 | K181722 | Polyethylene Catheter | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 18, 2019 | K181097 | Cook Cystostomy Catheter Set | KOB | Unknown | Cook Incorporated | accessdata.fda.gov |
| January 11, 2019 | K183467 | Roadrunner Extra Support Wire Guide | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 26, 2018 | K182709 | One-Step Suprapubic Introducer | KOB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 20, 2018 | K183036 | Dilator Sets | DRE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 20, 2018 | K180830 | Reuter Tip Deflecting Wire Guide | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 19, 2018 | K180846 | Arterial Pressure Monitoring Set/Tray | DQO | Unknown | Cook Incorporated | accessdata.fda.gov |
| December 12, 2018 | DEN170055 | Retrograde Intubation Set | QCX | Unknown | Cook Incorporated | accessdata.fda.gov |
| November 30, 2018 | K180792 | Arterial Pressure Monitoring Set/Tray | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 23, 2018 | K180557 | Greene Renal Transplant Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 6, 2018 | K181757 | Günther Tulip® Vena Cava Filter Retrieval Set | MMX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 30, 2018 | K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | KOB | Unknown | Cook Incorporated | accessdata.fda.gov |
| October 26, 2018 | K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 26, 2018 | K180291 | Cook Silicone Balloon HSG Catheter | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 26, 2018 | K180286 | Polyethylene Catheter | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 24, 2018 | K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 5, 2018 | K180054 | Royal Flush Plus High-Flow Catheter | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 28, 2018 | K180216 | Seidmon Antegrade AQ Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 21, 2018 | K180029 | Malecot Nephrostomy Catheter/Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 14, 2018 | K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | EYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 13, 2018 | K180053 | Sof-Flex Ureteral Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 17, 2018 | K181713 | Ultraxx Nephrostomy Balloon Catheter Set | LJE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 30, 2018 | K181431 | Laser Ureteral Catheter | GEX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 26, 2018 | K181712 | San Antonio Stopcock | ODC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 17, 2018 | K173654 | Ureteral Dilator Sets, Ureteral Dilators | EZN | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 12, 2018 | K180552 | Modified Novy Cornual Cannulation Set | MOV | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 28, 2018 | K181144 | Angled Tip Ureteral Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 22, 2018 | K173414 | Advance Biliary Balloon Catheter | GCA | Unknown | Cook Incorporated | accessdata.fda.gov |
| June 14, 2018 | K181351 | Double Flexible Tipped Wire Guides | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 7, 2018 | K173155 | Pakter Curved Needle Set | BSP | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 4, 2018 | K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 24, 2018 | K180756 | Safety Wire Guide Introducer | EZN | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 7, 2018 | K180034 | Weinmann Tracheostomy Exchange Set | JOH | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 3, 2018 | K172980 | Micropuncture Pedal Access Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 2, 2018 | K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | EZN | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 1, 2018 | K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets | FGE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 23, 2018 | K171917 | Frova Intubating Introducer | BTR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 19, 2018 | K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | EZN | Unknown | Cook Incorporated | accessdata.fda.gov |
| April 16, 2018 | K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | FAD | Unknown | Cook Incorporated | accessdata.fda.gov |
| April 13, 2018 | K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| April 11, 2018 | K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 30, 2018 | K171997 | Mandril Wire Guide | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 30, 2018 | K171988 | Performer Guiding Sheath | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 26, 2018 | K172017 | Black Silicone Filiform Double Pigtail Stent Set | FAD | Unknown | Cook Incorporated | accessdata.fda.gov |
| March 22, 2018 | K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | ODC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 19, 2018 | K171912 | Double Flexible Tip Wire Guides | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 9, 2018 | K171820 | Transjugular Liver Access Sets | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 9, 2018 | K171764 | Fixed Core Wire Guides | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 7, 2018 | K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 1, 2018 | K171915 | Nathanson Transcystic Bile Duct Stone Exploration Pack | LQR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 23, 2018 | K171601 | Ultraxx Nephrostomy Balloon Catheter | LJE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 16, 2018 | K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 15, 2018 | K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | LKF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 1, 2018 | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 25, 2018 | K171264 | Royal Flush Catheter | DQO | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 10, 2018 | K172051 | Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 10, 2018 | K171445 | Amplatz Support Wire Guide with Apex Curve | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 5, 2018 | K171948 | Roadrunner Extra Support Wire Guide | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 20, 2017 | K173685 | Peel-Away Introducer Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 20, 2017 | K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design | DYB | Unknown | Cook Incorporated | accessdata.fda.gov |
| December 15, 2017 | K173687 | Strange Bile Duct Stone Exploration Set | LQR | Unknown | Cook Incorporated | accessdata.fda.gov |
| December 13, 2017 | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath | FED | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 12, 2017 | K170898 | Wittich Nitinol Stone Basket | LQR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 22, 2017 | K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | GBM | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 17, 2017 | K173068 | Performer Introducer | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 13, 2017 | K170931 | CXI TriForce Peripheral Crossing Set | KRA | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 7, 2017 | K173009 | NCompass Nitinol Stone Extractors | LQR | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 26, 2017 | K172325 | Rhapsody H-30 Holmium Laser System | GEX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 19, 2017 | K172527 | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe | LJE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 28, 2017 | K170020 | Peel-Away Introducer Set | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 14, 2017 | K170323 | Entuit Start Initial Placement Gastrostomy Set | KGC | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 28, 2017 | K170010 | Salle Intraoperative Pyeloplasty Stent Set | FAD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 24, 2017 | K171853 | Liver Access and Biopsy Sets | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| August 21, 2017 | K171897 | Approach CTO Microwire Guide | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 14, 2011 | P100028 | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM | NIN | 4 | October 8, 2014 | accessdata.fda.gov |
| May 23, 2003 | P020018 | ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM | MIH | 65 | September 17, 2026 | accessdata.fda.gov |
| September 30, 1994 | P900007 | COOK CHORIONIC VILLUS SAMPLING SET | LLX | 5 | April 2, 2009 | accessdata.fda.gov |
| April 26, 1989 | P850049 | COOK BIRD'S NEST VENA CAVA FILTER | DTK | 9 | February 3, 2006 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 16, 2026 | 99875 | Class II | Ongoing | Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112 | The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment. | accessdata.fda.gov |
| April 2, 2026 | 98682 | Class I | Ongoing | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyeth | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. | accessdata.fda.gov |
| March 5, 2026 | 98495 | Class II | Ongoing | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | accessdata.fda.gov |
| November 26, 2025 | 98027 | Class II | Ongoing | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFA | Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. | accessdata.fda.gov |
| May 15, 2025 | 96848 | Class I | Ongoing | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves | Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. | accessdata.fda.gov |
| April 17, 2025 | 96703 | Class II | Ongoing | Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686 | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. | accessdata.fda.gov |
| April 17, 2025 | 96702 | Class II | Ongoing | Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. | accessdata.fda.gov |
| October 14, 2024 | 95582 | Class II | Ongoing | Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 | Devices from the affected device lots have labels that state the incorrect expiration dates. | accessdata.fda.gov |
| October 8, 2024 | 95528 | Class II | Ongoing | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G | Affected device lots have labels that state the incorrect expiration dates. | accessdata.fda.gov |
| September 16, 2024 | 95405 | Class II | Ongoing | Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve. | Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect. | accessdata.fda.gov |
| May 15, 2024 | 94696 | Class II | Ongoing | Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direc | Product labels state the incorrect expiration dates that extends beyond their true expiration date | accessdata.fda.gov |
| March 1, 2024 | 94196 | Class II | Ongoing | Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | accessdata.fda.gov |
| April 7, 2023 | 92083 | Class I | Ongoing | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8 | There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories. | accessdata.fda.gov |
| August 16, 2022 | 90793 | Class II | Ongoing | Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874) | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | accessdata.fda.gov |
| July 19, 2022 | 90710 | Class II | Ongoing | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures. | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | accessdata.fda.gov |
| May 25, 2022 | 90393 | Class II | Completed | Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838 | The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia. | accessdata.fda.gov |
| May 5, 2022 | 90103 | Class II | Ongoing | Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | accessdata.fda.gov |
| November 12, 2021 | 89072 | Class II | Terminated | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neur | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa | accessdata.fda.gov |
| October 13, 2021 | 89104 | Class II | Ongoing | Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment. | Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used. | accessdata.fda.gov |
| October 8, 2021 | 88808 | Class II | Terminated | Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator. | Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death. | accessdata.fda.gov |
| September 28, 2021 | 88787 | Class II | Terminated | Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator. | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time. | accessdata.fda.gov |
| January 4, 2021 | 87087 | Class II | Terminated | Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN | Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation. | accessdata.fda.gov |
| November 24, 2020 | 86804 | Class I | Terminated | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronar | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood f | accessdata.fda.gov |
| October 22, 2020 | 86642 | Class I | Terminated | Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical device | Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide. | accessdata.fda.gov |
| August 31, 2020 | 86411 | Class II | Terminated | Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an.038-inch (.97 mm) diameter, 30 cm PTFE-c | The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation. | accessdata.fda.gov |
| August 11, 2020 | 86242 | Class II | Terminated | Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 Z | May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU | accessdata.fda.gov |
| July 30, 2020 | 86256 | Class II | Terminated | Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder | Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set;pouch label reflects the packaged product. | accessdata.fda.gov |
| June 2, 2020 | 85805 | Class II | Terminated | Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endova | Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU. | accessdata.fda.gov |
| April 30, 2020 | 85605 | Class II | Terminated | Pressure Monitoring Set, C-PMS, G02838 | The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion. | accessdata.fda.gov |
| April 15, 2020 | 85456 | Class II | Terminated | Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire | The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location. | accessdata.fda.gov |
| March 6, 2020 | 85187 | Class II | Terminated | Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643 | The printed expiration dates are incorrect. | accessdata.fda.gov |
| January 16, 2020 | 84778 | Class II | Terminated | Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft. | The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Sizing Worksheet to include associated information. | accessdata.fda.gov |
| December 27, 2019 | 84560 | Class II | Terminated | Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC | Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly. | accessdata.fda.gov |
| November 8, 2019 | 84212 | Class I | Terminated | CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides). | accessdata.fda.gov |
| October 21, 2019 | 84125 | Class II | Terminated | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph | The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | accessdata.fda.gov |
| October 3, 2019 | 84108 | Class II | Terminated | Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity. | Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle. | accessdata.fda.gov |
| September 17, 2019 | 83921 | Class II | Terminated | Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax. | Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device. | accessdata.fda.gov |
| May 24, 2019 | 82888 | Class I | Terminated | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutane | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient. | accessdata.fda.gov |
| May 2, 2019 | 82910 | Class II | Terminated | Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT | The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product. | accessdata.fda.gov |
| April 26, 2019 | 82904 | Class II | Terminated | Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIM | may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention. | accessdata.fda.gov |
| April 22, 2019 | 82795 | Class II | Terminated | Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: | Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting. | accessdata.fda.gov |
| April 9, 2019 | 82692 | Class II | Terminated | Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 | Affected products may have been manufactured with the catheter distal end hole too small | accessdata.fda.gov |
| February 1, 2019 | 82124 | Class I | Terminated | Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures. | The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion. | accessdata.fda.gov |
| January 4, 2019 | 82026 | Class II | Terminated | Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. | accessdata.fda.gov |
| December 21, 2018 | 82007 | Class II | Terminated | Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 | The products were manufactured with longer than specified sheaths. | accessdata.fda.gov |
| December 19, 2018 | 81979 | Class II | Terminated | Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdo | There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot. | accessdata.fda.gov |
| May 31, 2018 | 80492 | Class II | Terminated | VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for shor | This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS). | accessdata.fda.gov |
| April 16, 2018 | 79861 | Class II | Terminated | Advance 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2.0 and PTA5-35-135-4-4.0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance 35LP Low Profile PTA Balloon Dilation | Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa. | accessdata.fda.gov |
| March 29, 2018 | 79789 | Class II | Terminated | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube. | accessdata.fda.gov |
| March 22, 2018 | 79713 | Class II | Terminated | Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration. | Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user. | accessdata.fda.gov |
| January 31, 2018 | 79731 | Class II | Terminated | StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044 | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. | accessdata.fda.gov |
| January 12, 2018 | 79711 | Class II | Terminated | MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture. | The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater. | accessdata.fda.gov |
| December 19, 2017 | 79471 | Class II | Terminated | Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos. | accessdata.fda.gov |
| October 19, 2017 | 79192 | Class II | Terminated | Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding | Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. | accessdata.fda.gov |
| October 13, 2017 | 79195 | Class II | Terminated | Amplatz Extra Stiff Whisker Wire Guide | Label does not state that the product is heparin-coated. | accessdata.fda.gov |
| July 31, 2017 | 79050 | Class II | Terminated | Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous o | Central venous catheters may not fit over guide wire potentially causing procedure delay. | accessdata.fda.gov |
| May 9, 2017 | 77304 | Class II | Terminated | Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages | Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. | accessdata.fda.gov |
| May 3, 2017 | 77307 | Class II | Terminated | OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue a | Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. | accessdata.fda.gov |
| May 3, 2017 | 77305 | Class II | Terminated | Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages | Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. | accessdata.fda.gov |
| May 1, 2017 | 77167 | Class II | Terminated | Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. | accessdata.fda.gov |
| April 25, 2017 | 77217 | Class II | Terminated | Pereyra-Raz Ligature Carrier | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products | accessdata.fda.gov |
| March 7, 2017 | 76927 | Class II | Terminated | Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set | Product may overheat, melt, and burn patient. | accessdata.fda.gov |
| February 1, 2017 | 76360 | Class II | Terminated | Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients. | accessdata.fda.gov |
| November 28, 2016 | 75793 | Class II | Terminated | Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray | Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no r | accessdata.fda.gov |
| June 24, 2016 | 74561 | Class I | Terminated | Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS- | Potential coating contamination with glass particles. | accessdata.fda.gov |
| April 15, 2016 | 74010 | Class II | Terminated | Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary s | accessdata.fda.gov |
| January 27, 2016 | 73398 | Class II | Terminated | UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the muscul | Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend AQ Ureteral Dilation Balloon Catheter Set and vice versa. | accessdata.fda.gov |
| January 20, 2016 | 73163 | Class II | Terminated | Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices | Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. | accessdata.fda.gov |
| January 8, 2016 | 73083 | Class II | Terminated | Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator | Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids. | accessdata.fda.gov |
| January 6, 2016 | 73056 | Class I | Terminated | Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffi | A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, | accessdata.fda.gov |
| November 19, 2015 | 72718 | Class II | Terminated | VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain. | Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling. | accessdata.fda.gov |
| October 21, 2015 | 72518 | Class II | Terminated | Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use. | Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing. | accessdata.fda.gov |
| October 7, 2015 | 72387 | Class I | Terminated | Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are desig | Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded 10/07/2015 to include additional catheters. | accessdata.fda.gov |
| July 2, 2015 | 71692 | Class I | Terminated | Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are | Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. | accessdata.fda.gov |
| May 28, 2015 | 71430 | Class II | Terminated | Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrah | Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long. | accessdata.fda.gov |
| May 14, 2015 | 71287 | Class II | Terminated | LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inne | Includes Information not stated in the intended use. | accessdata.fda.gov |
| July 17, 2014 | 68914 | Class I | Terminated | CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiov | This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire. | accessdata.fda.gov |
| April 18, 2013 | 64975 | Class I | Terminated | Zilver PTX Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated w | Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occ | accessdata.fda.gov |
| February 15, 2012 | 61177 | Not yet classified | Terminated | Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, Product Usage: Culture oil is intended to be used as an oil overlay for culture | Cook Medical is recalling Sydney IVF Culture Oil due to a number of recent customer complaints that have identified it as a possible cause of embryo degeneration at day 5/6. | accessdata.fda.gov |
| April 15, 2011 | 58613 | Not yet classified | Terminated | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, 18 Fr ID/ 7.1 mm OD, Sterile | The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material. | accessdata.fda.gov |
| October 4, 2010 | 57663 | Not yet classified | Terminated | Peripherally Inserted Central Venous Catheter Tray Silicone, CPICSY401HOPKINS0911 00, G13169, 4.0 Fr/60cm, Sterile, Cook Incorporated, 750 Daniels Way, Bloomington, IN 47404, USA | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe ster | accessdata.fda.gov |
| April 21, 2010 | 56084 | Not yet classified | Terminated | Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403. | These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly. | accessdata.fda.gov |
| May 8, 2008 | 48169 | Not yet classified | Terminated | Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. | The product length is declared incorrectly in mm when the unit of measurement should be cm. | accessdata.fda.gov |
| December 7, 2007 | 46151 | Not yet classified | Terminated | Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire:.035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C- | Packaging Problem: The peel-away sheath does not peel uniformly or completely. | accessdata.fda.gov |
| August 15, 2007 | 44879 | Not yet classified | Terminated | THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter.035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label) | The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address. | accessdata.fda.gov |
| February 28, 2007 | 37568 | Not yet classified | Terminated | Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (orde | Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0. | accessdata.fda.gov |
| January 2, 2007 | 37102 | Not yet classified | Terminated | COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A. | These catheters do not include the proximal sidehole as required by the specification. | accessdata.fda.gov |
| September 21, 2006 | 36391 | Not yet classified | Terminated | Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size.035 in | The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40) | accessdata.fda.gov |
| January 26, 2006 | 34657 | Not yet classified | Terminated | Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size.035 in | The side of the boxes give incorrect sizes for these stents. The label front is correct. | accessdata.fda.gov |
| October 24, 2005 | 34162 | Not yet classified | Terminated | Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 7.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size. | The side of the box gives the size of the stent as 10 x 40 instead of the actual size of 7 x 40. The label front is correct. | accessdata.fda.gov |
| September 26, 2005 | 33700 | Not yet classified | Terminated | Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter,.038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with.038'' end hole; Reorder # MWCE-38-20-20. | The coil is 20 centimeters in length, but the label states the length is 20 millimeters. | accessdata.fda.gov |
| December 20, 2004 | 30721 | Not yet classified | Terminated | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System ( A= 22mm, B=112mm, C=82mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-82. | The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft. | accessdata.fda.gov |
| June 10, 2004 | 29300 | Not yet classified | Terminated | Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80. | Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use. | accessdata.fda.gov |
| July 1, 2003 | 26631 | Not yet classified | Terminated | Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 cc; order number PVA-50. | Bottle contains less product than is declared on the label. | accessdata.fda.gov |
| November 25, 2002 | 25109 | Not yet classified | Terminated | COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC | The tip of the stiffened cannula might break during use and remain in the patient. | accessdata.fda.gov |
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- All makers of Device, Vascular, For Promoting Embolization
Updated October 15, 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.