Agency classClass IOur severity:Severe FDA (Devices)·Z-1132-2020·Announced 2020-02-26

Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon."

Plain-English summary

Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters, Reference 1012453-20, due to a defect where the balloon may exhibit difficulty or inability to deflate. The recall covers a total of 39,687 units, including 13,891 units distributed in the United States and 25,796 units distributed outside the United States.

The affected devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, balloon dilatation of a coronary artery occlusion in patients with ST-segment elevation myocardial infarction, and balloon dilatation of a stent after implantation. The recall includes specific lot numbers: 90801G1, 90925G1, 90812G1, 91010G2, 90818G1, 91022G1, 90818G2, 91025G1, 90904G1, 91101G1, and 90912G1.

Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected devices. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product: NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM 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…
Manufacturer: Abbott Vascular
Category: Medical Device — Cardiovascular
Hazard: device-malfunction

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 →

Same manufacturer · Abbott Vascular

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