Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Summary
The FDA issued a Class II for Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO by Abbott Medical. Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could pot.
Details
Source
Device Recall
External ID
Z-0494-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Lot/Code Info: UDI-DI (GTIN): 5415067045799, Serial Numbers: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, & 20213055.
Quantity Affected: 8 OUS
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.
Distribution
New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-17
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Medical has 86 FDA actions in our database, including 39 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Medical have FDA actions?
Abbott Medical has 86 FDA actions in our database, including 39 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0494-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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