Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a score of at least 4 (Severe) due to the potential for serious adverse health consequences.
Plain-English summary
Abbott Vascular is recalling the NC Traveler Coronary Dilatation Catheter (REF 1013157-08, NC Traveler RX 4.0 X 8MM) due to a potential defect where the balloon may exhibit difficulty or inability to deflate. The recall covers 791 units distributed worldwide, with zero units distributed in the United States.
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. The affected units were distributed in various countries outside the US, including Canada, the United Kingdom, and Australia. The specific lot number for the recalled units is 91010G1.
Healthcare providers and patients should stop using the affected catheters and contact Abbott Vascular for further instructions. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by Abbott Vascular 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 17 products in this recall →Related recalls
Same manufacturer · Abbott Vascular
See all →- HighMitraClip Clip Delivery System Recalled for Locking Malfunctions
FDA (Devices) · 2022-10-26
- HighAbbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk
FDA (Devices) · 2022-10-26
- HighMitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction
FDA (Devices) · 2022-10-26
- SevereDragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk
FDA (Devices) · 2022-05-25
- HighAbbott Vascular Cardiovascular Device Recalled for Leaks and Loose Connections
FDA (Devices) · 2022-04-20
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12