Data / Medical devices / United States / Covidien llc
Covidien llc: FDA-registered device maker in Santa Clara, CA, United States, 28 510(k) clearances
Covidien llc is registered with the FDA (registration 3004904811) in Santa Clara, CA, United States. It lists 10 device types. The FDA files 28 510(k) clearances under its listings, the newest dated July 21, 2023. 30 recall events name it as the recalling firm (5 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004904811
- Address
- 3062 Bunker Hill Lane, Santa Clara, CA, United States, 95054
- Owner or operator
- Covidien llc (1282497)
- Roles
- Specification developer
- First device listed
- April 19, 2012
- Registered through
- 2027
- Brand names listed
- BNX Fine Needle Aspiration System, Barrx 360 Express RFA Balloon Catheter, Barrx 360 RFA Balloon Catheter and Barrx RFA Cleaning Cap, Barrx 360 Soft Sizing Balloon, Barrx 60 RFA Focal Catheter, Barrx 90 RFA Focal Catheter, Barrx Anorectal RFA Wand, Barrx Channel RFA Endoscopic Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
| Endoscopic Traction Device | QSW | 2 | Specification developer | accessdata.fda.gov |
| Esophageal Dilator Balloon With Or Without Electrode Sensors | PID | 2 | Specification developer | accessdata.fda.gov |
| Esophageal Dilator With Balloon And Electrode Sensors | PIE | 2 | Specification developer | accessdata.fda.gov |
| Esophagoscope (Flexible Or Rigid) | EOX | 2 | Specification developer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Specification developer | accessdata.fda.gov |
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Specification developer | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | Specification developer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 21, 2023 | K231861 | EndoflipTM 300 System | FFX | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| June 13, 2022 | DEN220006 | ProdiGI | QSW | Unknown | Covidien, LLC | accessdata.fda.gov |
| May 7, 2020 | K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 15, 2019 | K183072 | EndoFLIP System | FFX | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| August 16, 2018 | K181020 | Cytosponge Cell Collection Device | EOX | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| April 26, 2018 | K180037 | Beacon EUS Access System | FCG | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| January 18, 2018 | K173559 | Barrx SB RFA Endoscopic Catheter | KNS | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 22, 2017 | K172128 | EsoFLIP® ES-310 Balloon Catheter | PIE | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| January 24, 2017 | K162802 | Barrx Anorectal RFA Wand | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| April 5, 2016 | K160360 | Barrx FLEX RFA Energy Generator | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 30, 2015 | K152586 | Beacon Fine Needle Fiducial System | NEU | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 28, 2015 | K150251 | Barrx Anorectal RFA Wand | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| May 1, 2015 | K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | FCG | Substantially Equivalent | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | accessdata.fda.gov |
| October 6, 2014 | K141894 | SHARKCORE FINE NEEDLE BIOPSY SYSTEM | FCG | Substantially Equivalent | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | accessdata.fda.gov |
| October 1, 2014 | K142364 | Barrx RFA Self Sizing Balloon Catheter | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 25, 2014 | K142000 | ESOFLIP ES | PIE | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| June 5, 2014 | K140422 | HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM | GEI | Substantially Equivalent | Het Systems, LLC | accessdata.fda.gov |
| October 7, 2013 | K132337 | ESOFLIP BALLOON DILATION CATHETER | PID | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| July 26, 2013 | K130623 | BARRX CHANNEL RFA ENDOSCOPIC CATHETER | KNS | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| May 3, 2012 | K120431 | HALO90 ULTRA ABLATION CATHETER | GEI | Substantially Equivalent | Barrx Medical, Inc. | accessdata.fda.gov |
| January 5, 2012 | K112454 | HALO60 ABLATION CATHETER | GEI | Substantially Equivalent | Barrx Medical, Inc. | accessdata.fda.gov |
| December 30, 2010 | K103668 | BNX FINE NEEDLE ASPIRATION SYSTEM | FCG | Substantially Equivalent | Boston Endoscopic Engineering | accessdata.fda.gov |
| January 15, 2010 | K093855 | HALO 360 & SIZING BALLOON, MODEL 3441C | GEI | Substantially Equivalent | Barrx Medical, Incorporated | accessdata.fda.gov |
| January 8, 2010 | K093008 | HALO ABLATION CATHETER, MODEL 90-9100 | GEI | Substantially Equivalent | Barrx Medical, Incorporated | accessdata.fda.gov |
| November 10, 2009 | K092487 | HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A | GEI | Substantially Equivalent | Barrx Medical, Incorporated | accessdata.fda.gov |
| February 10, 2009 | K083737 | HALO ABLATION CATHETER | GEI | Substantially Equivalent | Barrx Medical, Incorporated | accessdata.fda.gov |
| February 2, 2009 | K083711 | MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 | GEI | Substantially Equivalent | Barrx Medical, Incorporated | accessdata.fda.gov |
| September 28, 1994 | K935198 | GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS | KNT | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 13, 2026 | 99176 | Class II | Ongoing | EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 | Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures. | accessdata.fda.gov |
| April 25, 2024 | 94541 | Class II | Ongoing | EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only | Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms. | accessdata.fda.gov |
| June 2, 2023 | 92560 | Class II | Ongoing | Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM | Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration. | accessdata.fda.gov |
| June 30, 2022 | 90622 | Class II | Ongoing | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | accessdata.fda.gov |
| April 27, 2022 | 90178 | Class II | Ongoing | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D | Due to incorrect size and configuration labeling of the detachable coil system. | accessdata.fda.gov |
| July 13, 2021 | 88447 | Class I | Ongoing | Pipeline Flex Embolization Device | Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube. | accessdata.fda.gov |
| February 14, 2020 | 85069 | Class I | Terminated | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. | Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to thi | accessdata.fda.gov |
| August 10, 2018 | 80831 | Class II | Terminated | ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use. | The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter. | accessdata.fda.gov |
| February 26, 2018 | 79463 | Class I | Terminated | MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore | There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire. | accessdata.fda.gov |
| October 5, 2016 | 75358 | Class I | Terminated | Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carot | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. | accessdata.fda.gov |
| June 6, 2016 | 74300 | Class II | Terminated | Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the co | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus. | accessdata.fda.gov |
| September 4, 2015 | 72165 | Class II | Terminated | -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeli | The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use. | accessdata.fda.gov |
| April 1, 2014 | 67893 | Class I | Terminated | Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery. | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. | accessdata.fda.gov |
| July 19, 2013 | 65810 | Class II | Terminated | Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal | Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing | accessdata.fda.gov |
| August 3, 2012 | 62867 | Class II | Terminated | HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex Syste | Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care. | accessdata.fda.gov |
| September 23, 2011 | 63188 | Class II | Terminated | UltraFlow HPC Flow Directed Micro Catheter, Model #. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician | The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled. | accessdata.fda.gov |
| May 25, 2011 | 58908 | Not yet classified | Terminated | HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use | Complaints of malfunction of the HALO ULTRA Ablation Catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position. | accessdata.fda.gov |
| March 23, 2011 | 58425 | Not yet classified | Terminated | Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyval | Device was shipped past the labeled expiration date. | accessdata.fda.gov |
| March 1, 2010 | 55696 | Not yet classified | Terminated | Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malform | ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production. | accessdata.fda.gov |
| November 10, 2009 | 54384 | Not yet classified | Terminated | Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufacture | Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period. | accessdata.fda.gov |
| February 4, 2009 | 51206 | Not yet classified | Terminated | KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery. | Product not sterile: 10 units were released for distribution without undergoing sterilization process. | accessdata.fda.gov |
| November 12, 2008 | 50776 | Not yet classified | Terminated | Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a h | ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011. | accessdata.fda.gov |
| September 18, 2008 | 49515 | Not yet classified | Terminated | Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B. | Some units may contain the wrong filter, which does not have the proper lock and may result in a leak. | accessdata.fda.gov |
| June 23, 2008 | 48988 | Not yet classified | Terminated | KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vert | Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of the diamond tip stylet during balloon kyphoplasty procedure. Other risks include delay to surgery and inconvenience to patient. | accessdata.fda.gov |
| January 30, 2008 | 47490 | Not yet classified | Terminated | X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8M | Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X-STOP IPD Device's universal wing assembly. This includes the potential for breakage of the wing screw. | accessdata.fda.gov |
| April 5, 2007 | 37821 | Not yet classified | Terminated | Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200. | Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures. | accessdata.fda.gov |
| June 6, 2006 | 35621 | Not yet classified | Terminated | St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander tha | Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant. | accessdata.fda.gov |
| April 25, 2006 | 39366 | Not yet classified | Terminated | Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089 | Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure. | accessdata.fda.gov |
| June 17, 2004 | 29443 | Not yet classified | Terminated | ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063 | Devices for which sterility may be compromised. | accessdata.fda.gov |
| October 13, 2003 | 27597 | Not yet classified | Terminated | KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical de | Devices for which sterility may be compromised as evidenced by a loss of package integrity. | accessdata.fda.gov |
Compare with other makers
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Updated August 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.