Agency classClass IIOur severity:High FDA (Devices)·Z-0495-2025·Announced 2024-11-27

Abbott Navitor Transcatheter Aortic Valve Recalled for Manufacturing Defect

Abbott is recalling Abbott Navitor Transcatheter Aortic Heart Valves (27 mm) due to a manufacturing error causing leaflet deflection values outside specifications. This could affect valve durability and potentially cause valve failure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II medical device recall with an identified manufacturing defect (leaflet deflection values outside specifications) in a critical cardiac device. While no illnesses or injuries have been reported, the potential for serious harm exists (valve failure), meeting the rubric criterion for a risk-of-harm product without reported injury.

Plain-English summary

Abbott Medical is recalling Abbott Navitor Transcatheter Aortic Heart Valves, model NVTR-27 (27 mm), Sterile. A manufacturing error resulted in the production of valves with leaflet deflection values that fall outside of established specifications. This defect could potentially affect the long-term durability of the affected valves and may cause valve failure.

The recall affects 5 units that were distributed internationally, including locations in New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, and the United Kingdom. The affected serial numbers are 20110016, 20155472, 20155476, 20166304, and 20168050.

The recalled product

Product: Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Manufacturer: Abbott Medical
Category: Medical Device — Implantable Cardiac Device
Hazard: manufacturing-defect
valve-failure
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

UDI-DI (GTIN): 5415067031594
Serial Numbers: 20110016
20155472
20155476
20166304
& 20168050.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 5 recalled by Abbott Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Abbott Medical

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