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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Abbott Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Abbott Medical
See all →- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighDeep brain stimulators recalled over loss of programmer communication
FDA (Devices) · 2025-11-19
- HighSpinal cord stimulators recalled over loss of programmer communication
FDA (Devices) · 2025-11-19
- HighAbbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk
FDA (Devices) · 2025-04-23
- HighMerlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
FDA (Devices) · 2025-01-01
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- SevereAbbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues
FDA (Devices) · 2020-02-26
- HighAbbott Vascular Recalls Armada 35 PTA Catheters Due to Inflation Issues
FDA (Devices) · 2012-10-03
- HighMedtronic Evolut R System Recalled for Potential Valve Leaflet Damage
FDA (Devices) · 2020-12-16
- SevereAbbott NC Traveler Coronary Dilatation Catheter Recall for Balloon Deflation Issues
FDA (Devices) · 2020-02-26
- HighMedtronic Evolut PRO+ System Recalled for Valve Leaflet Damage Risk
FDA (Devices) · 2020-12-16
- SevereAbbott NC Traveler Coronary Dilatation Catheter Recalled for Deflation Issues
FDA (Devices) · 2020-02-26