Abbott Navitor Heart Valve Recalled for Leaflet Deflection Manufacturing Defect
Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.
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 a FDA Class II medical device recall involving a risk-of-harm cardiac implant. While no injuries or illnesses have been reported, the potential for valve failure or durability issues in an aortic valve poses significant patient risk. The manufacturing defect affecting leaflet specifications represents a functional defect in a critical implantable device.
Plain-English summary
Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve (model NVRO-27) due to a manufacturing error. The affected valves have leaflet deflection values that fall outside the manufacturer's established specifications.
This manufacturing defect could potentially affect the long-term durability of the valve and may lead to valve failure. The affected serial numbers are 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, and 20213055.
The recalled valves were distributed to medical facilities in multiple countries including New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, and the United Kingdom.
Healthcare providers who have received or implanted these valves should consult the FDA recall notice for instructions on patient management and appropriate follow-up.
The recalled product
- Product
- Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
- Manufacturer
- Abbott Medical
- Hazard
- manufacturing-defect
- valve-failure
- durability-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 (9)
- UDI-DI (GTIN): 5415067045799
- Serial Numbers: 20158135
- 20172203
- 20183968
- 20184552
- 20184670
- 20184675
- 20190249
- & 20213055.
Distribution
Distribution scope not specified by the agency.
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