Abbott Vascular: 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 sten

Is my product affected?

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 myocardial perfusion b) ball

• UPC 08717648152092

Check against the official notice below — it lists the full affected range.

What happened

Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters because the balloons may have difficulty or inability to deflate. The affected devices are model REF 1012453-20 (4.50 x 8MM), with part number 1012454-08 and specific lot numbers ranging from 90801G1 through 91101G1. A total of 39,687 units have been distributed worldwide, including 13,891 units in the United States and 25,796 units in other countries.

The NC TREK RX Coronary Dilatation Catheter is used for balloon dilatation of stenosis in coronary arteries. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Details from the source

Reason for recall: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Distribution: Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federa Quantity: Total 39687 NC TREK units (13891 US and 25796 OUS) Lot/code info: Device Identifier/GTIN: 08717648152092 Part Number: 1012454-08 Lot Numbers: 90801G1 90925G1 90812G1 91010G2 90818G1 91022G1 90818G2 91025G1 90904G1 91101G1 90912G1

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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All FDA (Device enforcement) recalls