Data / Medical devices / United States / Medtronic Vascular
Medtronic Vascular: FDA-registered device maker in Danvers, MA, United States, 28 510(k) clearances and 1 PMA approval
Medtronic Vascular is registered with the FDA (registration 1220452) in Danvers, MA, United States. It lists 13 device types. The FDA files 28 510(k) clearances and 1 PMA approval under its listings, the newest dated April 23, 2026. 17 recall events name it as the recalling firm (4 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1220452
- Address
- 37A Cherry Hill Dr, Danvers, MA, United States, 01923
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- January 30, 1995
- Registered through
- 2027
- Brand names listed
- 5F Taiga, 5F and 6F Z2 Guiding Catheter, 5F and 8F Launcher Guiding Catheter, 6F Launcher Guiding Catheter, 6F Sherpa Balance Guiding Catheter, 6F Sherpa NX Balanced7F Sherpa NX Balanced, 6F Taiga, 6F Tiaga 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2026 | K253589 | Liberant™ RX Aspiration Catheter | QEZ | Substantially Equivalent | Medtronic Interventional Vascular, Inc. | accessdata.fda.gov |
| August 22, 2023 | K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| June 30, 2023 | K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| April 13, 2022 | K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) | MAV | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 19, 2016 | K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak | DQO | Unknown | Medtronic Vascular | accessdata.fda.gov |
| April 13, 2016 | K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit | MAV | Unknown | Medtronic, Inc. | accessdata.fda.gov |
| September 18, 2015 | K152335 | Export Advance Aspiration Catheter | DXE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 11, 2015 | K143316 | Attain Hybrid Guide Wire | DQX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 12, 2014 | K140695 | COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE | DQX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 22, 2013 | K132673 | 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 7, 2012 | K120808 | EXPORT XT CATHETER, EXPORT AP CATHETER | QEZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 11, 2011 | K103386 | MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 6, 2009 | K082873 | MEDTRONIC ANGIOGRAPHIC GUIDE WIRES | DQX | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 5, 2005 | K051846 | 7F SHERPA NX GUIDE CATHETER | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 22, 2005 | K050139 | MODIFICATION TO: EXPORT CATHETER | QEZ | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| December 13, 2004 | K042489 | 6F Z4 GUIDE CATHETER | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| July 31, 2003 | K030671 | MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 28, 2002 | K022764 | 7F LAUNCHER GUIDE CATHETER | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| May 17, 2002 | K021256 | Z3 GUIDE CATHETER | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| November 21, 2001 | K010579 | STENT SUPPORT GUIDE CATHETER | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 29, 2000 | K000677 | ZUMA GUIDE CATHETERS | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| September 4, 1998 | K982883 | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER | DQY | Substantially Equivalent | Medtronics Interventional Vascular | accessdata.fda.gov |
| February 3, 1995 | K945461 | PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) | DTL | Substantially Equivalent | Medtronics Interventional Vascular | accessdata.fda.gov |
| March 29, 1994 | K940063 | MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS | LIT | Substantially Equivalent | Medtronics Interventional Vascular | accessdata.fda.gov |
| February 8, 1993 | K923638 | ACESSORY PACK | LIT | Substantially Equivalent | Medtronics Interventional Vascular | accessdata.fda.gov |
| March 15, 1989 | K890325 | USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP | LIT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 12, 1989 | K884065 | CATH LAB MONITORING CATHETER | DQO | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 27, 1983 | K832607 | OPEN END SPRING GUIDE | DQX | Substantially Equivalent | C.R. Bard, Inc. | 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 |
|---|---|---|---|---|---|---|
| August 28, 2001 | P010015 | MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM | LWP | 574 | October 23, 2026 | 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 4, 2021 | 87952 | Class I | Terminated | Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream proces | The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers. | accessdata.fda.gov |
| January 15, 2021 | 87284 | Class II | Terminated | Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 | Sterility may be compromised due to an unsealed pouch | accessdata.fda.gov |
| August 25, 2020 | 86381 | Class I | Terminated | Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atri | Subsequent failure of catheters in the field and failed quality testing | accessdata.fda.gov |
| March 15, 2019 | 82525 | Class I | Terminated | SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM.070", REF SA6IMAK. for cardiovascular use | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. | accessdata.fda.gov |
| August 16, 2018 | 80919 | Class III | Terminated | Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are cor | accessdata.fda.gov |
| March 13, 2018 | 79591 | Class II | Terminated | Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box. | The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details. | accessdata.fda.gov |
| October 13, 2014 | 69488 | Class II | Terminated | Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K | Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the | accessdata.fda.gov |
| February 6, 2014 | 67490 | Class III | Terminated | Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the | Incorrect master label. | accessdata.fda.gov |
| October 21, 2013 | 66567 | Class I | Terminated | Cougar Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are s | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | accessdata.fda.gov |
| June 8, 2011 | 59111 | Not yet classified | Terminated | Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding c | Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve | accessdata.fda.gov |
| July 16, 2010 | 56276 | Not yet classified | Terminated | Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. | Product sterility may be compromised due to breach of package seal integrity. | accessdata.fda.gov |
| October 7, 2008 | 50078 | Not yet classified | Terminated | 5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin in | Failure to insert the guidewire through the 18 gauge introducer needle | accessdata.fda.gov |
| August 29, 2007 | 44724 | Not yet classified | Terminated | Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US) | Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged. | accessdata.fda.gov |
| April 5, 2006 | 35236 | Not yet classified | Terminated | CATHETER LA5IMAA 5F 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model #: LA5IMAA | Potential for non-sterility due to loss of package integrity | accessdata.fda.gov |
| January 14, 2004 | 28128 | Not yet classified | Terminated | Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029 | Catheter distal tip may separate | accessdata.fda.gov |
| March 17, 2003 | 25847 | Not yet classified | Terminated | Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH | The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label. | accessdata.fda.gov |
| January 31, 2003 | 25514 | Not yet classified | Terminated | Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200 | PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon | accessdata.fda.gov |
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Updated October 23, 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.