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.
What this means for you
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
- Hazard
- manufacturing-defect
- valve-failure
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
Distribution scope not specified by the agency.
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