FDA Enforcement
Class II
Ongoing
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Recall: Z-0494-2025
·
Reported November 27, 2024
Enforcement
- Recall Number
- Z-0494-2025
- Event ID
- 95627
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2024
- Initiation Date
- October 17, 2024
- Classification Date
- November 20, 2024
- Address
- 177 E County Road B, N/A, Saint Paul, MN, 55117, United States
Description
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Reason
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.
Code Info
UDI-DI (GTIN): 5415067045799, Serial Numbers: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, & 20213055.
Distribution
New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
Quantity
8 OUS