Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Reported: November 27, 2024 Initiated: October 17, 2024 #Z-0492-2025
Product Description
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Reason for Recall
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.
Details
- Recalling Firm
- Abbott Medical
- Units Affected
- 1 OUS
- Distribution
- New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile. Recalled by Abbott Medical. Units affected: 1 OUS.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2024. Severity: Moderate. Recall number: Z-0492-2025.
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