Abbott Vascular Recalls NC TREK Coronary Dilatation Catheters
Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters because the balloon may have difficulty or inability to deflate.
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 FDA classified this recall as Class I, which is defined by the rubric as Severe (score 4). A balloon that cannot deflate in a coronary artery poses a significant risk of serious injury or death.
Plain-English summary
Abbott Vascular is voluntarily recalling specific lots of the NC TREK RX Coronary Dilatation Catheter. The product is indicated for balloon dilatation of stenotic coronary arteries, occlusions, or stents to improve myocardial perfusion or restore flow.
The recall was initiated because the catheters may exhibit difficulty or inability to deflate the balloon. This defect could prevent the device from being withdrawn after use.
A total of 39,687 units are affected, including 13,891 distributed in the United States and 25,796 distributed outside the US. The distribution pattern includes countries across North America, South America, Europe, Asia, Africa, and Oceania. Affected lot numbers include 90819G1, 90927G1, 90819G2, 90930G1, 90916G1, 91031G1, and 90916G2.
Healthcare providers should stop using the affected devices immediately. Patients who have received these devices should contact their healthcare provider for guidance.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
- Manufacturer
- Abbott Vascular
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 defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22