Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect
Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or 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 an FDA Class II recall of a life-critical cardiac implant with a manufacturing defect that could lead to valve failure. No illnesses or injuries have been reported, placing this in the risk-of-harm category without documented incidents.
Plain-English summary
Abbott Medical is recalling the Abbott Navitor Transcatheter Aortic Heart Valve (29mm, model NVTR-29) due to a manufacturing error. A quality control issue resulted in the acceptance of valves with leaflet deflection values that fell outside established specifications.
The out-of-specification leaflet deflection could potentially affect the long-term durability of the implanted valve and may result in valve failure.
The affected valve was distributed to patients in New York and internationally across multiple countries including Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, and the United Kingdom.
Physicians who implanted or have in stock the affected valve should review the recall information and consult Abbott Medical's guidance for recommendations regarding patient monitoring, management, or device replacement. Patients who received this valve should contact their healthcare provider if they have any questions or concerns.
The recalled product
- Product
- Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
- Manufacturer
- Abbott Medical
- Hazard
- device-failure
- manufacturing-defect
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 (2)
- UDI-DI (GTIN): 5415067031600
- Serial Number: 20131478
Distribution
Distribution scope not specified by the agency.
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