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MEDTRONIC VASCULAR, INC.

Last updated September 17, 2026

Information

Country: US
Address: 3576 Unocal Pl, Santa Rosa, CA, 95403
Website: medtronic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)633-8766
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3001452571
DUNS Number: 080009661

Catalogue (509)

Page 1 of 11

Device	Model / Reference	Registries	Class	Status
APTUS Heli-FX®	HG-18-90-42	FDA UDI	Class II	Active
APTUS Heli-FX®	HG-16-62-28	FDA UDI	Class II	Unknown
APTUS Heli-FX®	HG-18-90-32	FDA UDI	Class II	Active
Heli-FX™ Thoracic EndoAnchor™ System	HG-18-90-22	FDA UDI	Class II	Active
Heli-FX™ Ancillary EndoAnchor™ Cassette	EC-05	FDA UDI	Class II	Active
Heli-FX™ Thoracic EndoAnchor™ System	HG-18-90-42	FDA UDI	Class II	Active
Heli-FX™ Thoracic EndoAnchor™ System	HA-18-114	FDA UDI	Class II	Active
APTUS Heli-FX®	HA-18-114	FDA UDI	Class II	Active
APTUS Heli-FX®	HG-18-90-22	FDA UDI	Class II	Active
Heli-FX™ Thoracic EndoAnchor™ System	HG-18-90-32	FDA UDI	Class II	Active
Heli-FX™ EndoAnchor™ System	HG-16-62-28	FDA UDI	Class II	Active
Heli-FX™ EndoAnchor™ System	HA-18-114	FDA UDI	Class II	Unknown
Medtronic Model 5513 Endocardial Pacing Lead	K870885	FDA 510(k)	Class III	Active
Heparin Dose Response Cartridge, Model 304-20	K042070	FDA 510(k)	Class II	Active
Carmeda Coated Cardiotherm Blood Cardioplegia Systems (cbctxxx Series And Cbctxxxbr Series)	K973475	FDA 510(k)	Class II	Active
Programmable Stimulator 2352	K833421	FDA 510(k)	Class II	Active
5f Medtronic Launcher Guide Catheter	K030779	FDA 510(k)	Class II	Active
Resume Ii Lead Kit For Spinal Cord Stimulation (scs) And Peripheral Nerve Stimulation (pns), Resume Tl Lead Kit For	K032561	FDA 510(k)	Class II	Active
Minix 8341m And Minix St 8331m Pulse Generators	K894055	FDA 510(k)	Class III	Active
Model 1850 Electrode	K903918	FDA 510(k)	Class II	Active
Medtronic S3 Tm System	K821004	FDA 510(k)	Class II	Active
Cg Future Annuloplasty System, Model 638r	K061127	FDA 510(k)	Class II	Active
Medtronic Clearview Intravascular Arteriotomy Shunt	K993677	FDA 510(k)	Class II	Active
Selectsite C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-Xs59 & C304-Xl74	K061416	FDA 510(k)	Class II	Active
Medtronic Algoline Intraspinal Catheter System	K965251	FDA 510(k)	Class II	Active
Z3 Guide Catheter	K021256	FDA 510(k)	Class II	Active
#9431 Teletrace, Telephone, Ekg Transmitter	K852971	FDA 510(k)	Class II	Active
Neurological Lead Accessories	K936099	FDA 510(k)	Class II	Active
Model 2872 Bipolar Lead Adaptor Kit	K982220	FDA 510(k)	Class II	Active
Myelostat Dorsal Cord Stimulator, Etc.	K801384	FDA 510(k)	Class II	Active
Medtronic Models 69914/699ou	K791667	FDA 510(k)	Class III	Active
Teletrace Telephone Ekg Transmitter	K780158	FDA 510(k)	Class II	Active
Medtronic Model 5455s Disposable Surgical Cable	K894981	FDA 510(k)	Class II	Active
Myocardial Lead Implant Tool, Model 10626	K022238	FDA 510(k)	Class I	Active
Medtronic Model 7495 Extension Kit	K990104	FDA 510(k)	Class II	Active
Medtronic Permanent Lead Introducer	K854559	FDA 510(k)	Class II	Active
Medtronic Model 5311b A-V Pacing System Analyzer	K884331	FDA 510(k)	Class II	Active
Reveal Insertable Loop Recorder (ilr) System	K972242	FDA 510(k)	Class II	Active
Bifurcated Y-Extension	K953742	FDA 510(k)	Class II	Active
Medtronic #1992-2 Dual Rate Transmitter	K820988	FDA 510(k)	Class II	Active
Alternate Packaging Configuration For Pacing Leads	K890527	FDA 510(k)	Class III	Active
Medtronic Model 3861 Temporary Screening Lead Kit	K912764	FDA 510(k)	Class II	Active
Medtronics Models 8320/8322/8329	K852688	FDA 510(k)	Class III	Active
Model 3487a Pisces Epidural Lead	K885033	FDA 510(k)	Class II	Active
Model 5866-24 Pacemaker Lead Adaptor	K864856	FDA 510(k)	Class III	Active
Medtronic Export Ap Catheter	K081573	FDA 510(k)	Class II	Active
Medtronic Permanent Lead Introducer, Various Mdls	K911236	FDA 510(k)	Class II	Active
Modification To Export Aspiration Catheter	K030201	FDA 510(k)	Class II	Active
Medtronic Model 3625 Screener System	K932948	FDA 510(k)	Class II	Active
Medtronic Minimax Hollow Fiber Oxygenator	K897068	FDA 510(k)	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 23, 2022	Z-1043-2022	—	open, classified	Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Mar 23, 2022	Z-1042-2022	—	open, classified	Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Dec 21, 2021	Z-0657-2022	—	open, classified	Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
Oct 15, 2021	Z-0291-2022	—	open, classified	Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Oct 15, 2021	Z-0292-2022	—	open, classified	Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Oct 15, 2021	Z-0290-2022	—	open, classified	During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Jun 7, 2021	Z-2135-2021	—	open, classified	During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Jun 7, 2021	Z-2136-2021	—	open, classified	During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
May 4, 2021	Z-1860-2021	—	terminated	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.
Apr 28, 2021	Z-1976-2021	—	terminated	Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Feb 12, 2021	Z-1201-2021	—	open, classified	Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
Jan 15, 2021	Z-1248-2021	—	terminated	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Z-1245-2021	—	terminated	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Z-1246-2021	—	terminated	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Z-1247-2021	—	terminated	Sterility may be compromised due to an unsealed pouch
Aug 25, 2020	Z-0088-2021	—	terminated	Subsequent failure of catheters in the field and failed quality testing
Aug 25, 2020	Z-0087-2021	—	terminated	Subsequent failure of catheters in the field and failed quality testing
Aug 25, 2020	Z-0089-2021	—	terminated	Subsequent failure of catheters in the field and failed quality testing
Mar 15, 2019	Z-2605-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2644-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2651-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2749-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2698-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2699-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2732-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2643-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2579-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2574-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2709-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2589-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2575-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2674-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2591-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2604-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2603-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2738-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2562-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2750-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2686-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2688-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2621-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2684-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2721-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2744-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2682-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2733-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2656-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2662-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2647-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2630-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2565-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2654-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2649-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2571-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2635-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2576-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2626-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2692-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2611-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2714-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2633-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2578-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2600-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2618-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2583-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2636-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2752-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2596-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2581-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2726-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2632-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2672-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2593-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2568-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2685-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2652-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2671-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2639-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2585-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2680-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2638-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2710-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2719-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2646-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2718-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2564-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2742-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2594-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2664-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2715-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2717-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2736-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2658-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2650-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2592-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2569-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2597-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2634-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2712-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2747-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.