Abbott Navitor Transcatheter Aortic Heart Valve recall
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Why was Abbott Navitor Transcatheter Aortic Heart Valve recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): 5415067031594, Serial Numbers: 20110016, 20155472, 20155476, 20166304, & 20168050.
- Product
- Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
- Recalling firm
- Abbott Medical
- Quantity
- 5 OUS
- Distribution
- New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
- Recall date
- November 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)