Abbott Vascular: NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the ste

Is my product affected?

NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 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 myocardial perfusion b) bal

• UPC 08717648152078

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

What happened

Abbott Vascular is recalling the NC TREK RX Coronary Dilatation Catheter (4.00 X 15MM), a device used for balloon dilatation of coronary arteries. The recalled devices may exhibit difficulty or inability to deflate the balloon. A total of 39,687 units have been distributed worldwide, including 13,891 in the United States and 25,796 internationally across numerous countries. The affected lot numbers are: 90815G1, 91008G1, 90816G1, 91009G1, 90828G1, 91020G1, 90904G1, 91026G1, 90920G1, 91109G1, 90926G1, and 91117G1.

The recall notice 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 (13891 US and 25796 OUS) Lot/code info: Device Identifier/GTIN: 08717648152078 Part Number: 1012453-15 Lot Numbers: 90815G1 91008G1 90816G1 91009G1 90828G1 91020G1 90904G1 91026G1 90920G1 91109G1 90926G1 91117G1

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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• 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) ball2020-01-29

All FDA (Device enforcement) recalls