Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect
Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or 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: FDA Class II medical device with a structural defect affecting a critical organ. No reported hospitalizations or injuries, and the hazard is stated as potential rather than confirmed. Per the rubric, risk-of-harm products without reported injuries rate as High (3).
Plain-English summary
Abbott Medical is recalling three units of the Navitor transcatheter aortic heart valve (size 29mm, model NVRO-29) due to a manufacturing error. During production, quality control failed to reject valves with leaflet deflection measurements outside of established specifications. The affected serial numbers are 20150441, 20156804, and 20170535.
This defect could potentially affect the long-term durability of the valve and may cause valve failure. No reports of illness or injury related to this issue have been received.
The recalled units were distributed to New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, and the United Kingdom.
The recalled product
- Product
- Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
- Manufacturer
- Abbott Medical
- Affected units
- 3
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 (4)
- UDI-DI (GTIN): 5415067045775
- Serial Numbers: 20150441
- 20156804
- & 20170535
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.
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