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Data / Medical devices / United States / Medtronic Vascular

Medtronic Vascular: FDA-registered device maker in Santa Rosa, CA, United States, 11 510(k) clearances and 6 PMA approvals

Medtronic Vascular is registered with the FDA (registration 2953200) in Santa Rosa, CA, United States. It lists 10 device types. The FDA files 11 510(k) clearances and 6 PMA approvals under its listings, the newest dated November 17, 2023. 14 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Medtronic Vascular
FDA registration number
2953200
FEI number
3001452571
Address
3576 Unocal Pl, Santa Rosa, CA, United States, 95403
Owner or operator
Medtronic, Inc. (2112641)
Roles
Specification developer
First device listed
December 7, 2007
Registered through
2027
Brand names listed
Endurant II AUI Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant Stent Graft System, Heli-FX EndoAnchor System, Heli-FX Thoracic EndoAnchor System, IN.PACT™ AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter and more

Devices it lists

DeviceProduct codeClassRoleSource
Ablation Catheter, Renal DenervationQYI3Specification developeraccessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)BZN1Specification developeraccessdata.fda.gov
Catheter, PercutaneousDQY2Specification developeraccessdata.fda.gov
Coronary Drug-Eluting StentNIQ3Specification developeraccessdata.fda.gov
Drug-Coated Peripheral Transluminal Angioplasty CatheterPRC3Specification developeraccessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty CatheterONU3Specification developeraccessdata.fda.gov
Endovascular Suturing SystemOTD2Specification developeraccessdata.fda.gov
Introducer, CatheterDYB2Specification developeraccessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm TreatmentMIH3Specification developeraccessdata.fda.gov
Wire, Guide, CatheterDQX2Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 24, 2023K232570Steerant™ Super Stiff GuidewireDQXSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
November 21, 2018K182957Heli-FX EndoAnchor SystemOTDSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
December 20, 2017K171866Sentrant Introducer Sheath with Hydrophilic CoatingDYBSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
June 13, 2017K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTDSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
May 16, 2014K141041APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTEOTDSubstantially EquivalentAptus Endosystemsaccessdata.fda.gov
February 6, 2014K140036APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITHOTDSubstantially EquivalentAptus Endosystems, Inc.accessdata.fda.gov
April 26, 2013K123990SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATINGDYBSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
April 12, 2013K130677APTUS HELI-FX AORTIC SECUREMENT SYSTEMOTDSubstantially EquivalentAptus Endosystems, Inc.accessdata.fda.gov
August 8, 2012K121168APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTHOTDSubstantially EquivalentAptus Endosystems, Inc.accessdata.fda.gov
November 21, 2011DEN100026APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTEOTDUnknownAptus Endosystems, Inc.accessdata.fda.gov
April 13, 2005K050038RELIANT STENT GRAFT BALLOON CATHETERDQYSubstantially EquivalentMedtronic Endovascular Innovationsaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
November 17, 2023P220026Symplicity Spyral™ Renal Denervation SystemQYI17October 23, 2026accessdata.fda.gov
November 21, 2019P190008IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterPRC46May 21, 2026accessdata.fda.gov
April 28, 2017P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ88October 16, 2026accessdata.fda.gov
December 30, 2014P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxONU97September 24, 2026accessdata.fda.gov
April 1, 2011P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH69February 27, 2026accessdata.fda.gov
December 16, 2010P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH129May 12, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 23, 202289935Class IIOngoingMedtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM0402501Packaging for Balloon Catheters may be damaged resulting in loss of sterility.accessdata.fda.gov
September 13, 201778127Class IITerminatedMedtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts anIt was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.accessdata.fda.gov
October 23, 201572502Class IITerminatedAmphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP0Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.accessdata.fda.gov
March 3, 201467646Class IITerminatedFIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. MinneapMedtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.accessdata.fda.gov
October 7, 201366532Class IITerminatedResolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improvingA small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.accessdata.fda.gov
September 16, 201366334Class IITerminatedNC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation CatCompliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.accessdata.fda.gov
February 21, 201261278Not yet classifiedTerminatedTalent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the following designation: TFXXXXXXXXCP and TBXXXXXXXXCP. Medtronic Inc. Santa Rosa, CA 95403. The Talent Thoracic Stent GrafComplaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism.accessdata.fda.gov
April 30, 201055541Not yet classifiedTerminatedPioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculature over a standard lenNeedles may fail to retract and thus cause injury.accessdata.fda.gov
July 30, 200953126Not yet classifiedTerminatedMedtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by Medtronic Vascular, Sunnyvale, CA. Medical device system consisting oMislabeling-- The incorrect Instructions for use may have been included with this product.accessdata.fda.gov
July 17, 200953199Not yet classifiedTerminatedComplete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code 00613994186478, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. Indicated for use in the palliatMislabeling-- A lot of 5 mm x 120 mm stents were labeled as 6 mm x 80 mm stents and vice versa.accessdata.fda.gov
April 29, 200848097Not yet classifiedTerminatedAneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product number ILXCH161685, manufactured by Medtronic Cardiovascular, Santa Rosa, CA. The product is designed to treat infrarenal abdominal aorProducts may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.accessdata.fda.gov
December 10, 200746353Not yet classifiedTerminatedMedtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers Affected: All AAAdvantage models including: AEXC202040, IEXC121255, ILXC1212115, ILXC151585, AEXC222240, IEXC1Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.accessdata.fda.gov
June 8, 200429326Not yet classifiedTerminatedPercutaneous Transluminal Coronary Angioplasty system in sterile pouch.medical device for which sterility may be compromised because of improper seal.accessdata.fda.gov
February 27, 200325794Not yet classifiedTerminatedMedtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System for Biliary Catheter;Model #s: FB720VF, FB730 VF, FB740 VF, FB760 VF, FB820VF, FB830VF, FB840VF, FB860VF; FB720VL, FB730VL, FB820VL, FB830VL; FBDuring use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties.accessdata.fda.gov

Compare with other makers

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.