Abbott Navitor Titan Heart Valve Recall: Manufacturing Defect
Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.
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: FDA Class II recall of a cardiac valve with manufacturing defect affecting leaflet specification and risking valve failure. No injuries reported, placing this under 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Abbott Medical is recalling the Abbott Navitor Titan transcatheter aortic heart valve (model NVRO-35, 35 mm). One device was distributed in the United States (New York), and nine devices were distributed to Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, and the United Kingdom.
A manufacturing error allowed valves with leaflet deflection values outside the established specifications to be shipped. The defective leaflets could potentially compromise the valve's long-term durability and may result in valve failure.
Healthcare providers and patients who have received units with the affected serial numbers (20078589, 20357219, 20357226, 20357685, 20358319, 20358343, 20358351, 20358363, 20358368, 20358370) should contact Abbott Medical immediately to discuss appropriate next steps. Patients experiencing symptoms related to valve function should seek immediate medical evaluation.
The recalled product
- Product
- Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
- Manufacturer
- Abbott Medical
- Category
- Medical Device — Cardiac Valve
- Hazard
- manufacturing-defect
- valve-failure
- durability-issue
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 (11)
- UDI-DI (GTIN): 05415067045768
- Serial Numbers: 20078589
- 20357219
- 20357226
- 20357685
- 20358319
- 20358343
- 20358351
- 20358363
- 20358368
- & 20358370.
Distribution
Distribution scope not specified by the agency.
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