CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report

Abbott Navitor Transcatheter Aortic Heart Valve, Nvtr-29, Sterile recalled

Abbott Medical is recalling Abbott Navitor Transcatheter Aortic Heart Valve, Nvtr-29, Sterile, distributed in New York. The recall was initiated on 17 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI (GTIN): 5415067031600, Serial Number: 20131478

Quantity recalled1 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0492-2025
FDA event ID: 95627
Recalling firm: Abbott Medical, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 17 Oct 2024
FDA classified: 20 Nov 2024
Reported: 27 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

17 Oct 2024	Recall initiated by company
20 Nov 2024	Classified by FDA	+34 days
27 Nov 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile

Where it was distributed

New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.

New York

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI (GTIN): 5415067031600, Serial Number: 20131478

Where was it sold?

New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 95627

This product is part of a recall event; the main page for the event is Abbott Navitor Transcatheter Aortic Heart Valve, Nvtr-27, Sterile recalled.

Reported	Class	Recall	Company	Reason	Where
27 Nov 2024	CLASS II	Abbott Navitor Transcatheter Aortic Heart Valve, Nvtr-27, Sterile recalled	Abbott Medical	Device Malfunction	NY
27 Nov 2024	CLASS II	Abbott Navitor Titan, Vision Technology recalled by Abbott Medical	Abbott Medical	Device Malfunction	NY
27 Nov 2024	CLASS II	Abbott Navitor, Vision Technology recalled by Abbott Medical	Abbott Medical	Device Malfunction	NY
27 Nov 2024	CLASS II	Abbot Navitor, Vision Technology recalled by Abbott Medical	Abbott Medical	Device Malfunction	NY

More recalls from Abbott Medical

All 33

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	Merlin" Patient Care System (PCS) recalled by Abbott Medical	Abbott Medical	Device Malfunction	Nationwide
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23 Apr 2025Device	CLASS II	Aveir DR Leadless Pacemaker (LP) Ventricular Device recalled	Abbott Medical	Temperature Abuse	Nationwide
4 Dec 2024Device	CLASS III	Merlin@home with the MerlinOnDemand capability Transmitter recalled	Abbott Medical	Device Malfunction	Nationwide
4 Dec 2024Device	CLASS III	Merlin@home Transmitter recalled by Abbott Medical	Abbott Medical	Device Malfunction	Nationwide

Other Heart & Vascular Devices recalls

All 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide