Abbott Vascular: 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 ste

Is my product affected?

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 myocardial perfusion b) bal

• UPC 08717648152115

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

What happened

Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters (4.50 X 15MM BDC) worldwide due to a defect in which the balloon may exhibit difficulty or inability to deflate. The recall affects a total of 39,687 units, including 13,891 units distributed in the United States and 25,796 units distributed internationally across numerous countries. The affected devices are identified by part number 1012454-15 (Device Identifier/GTIN: 08717648152115) and involve specific lot numbers: 90819G1, 90927G1, 90819G2, 90930G1, 90916G1, 91031G1, and 90916G2.

The source document does not specify a remedy or recommended action for consumers or healthcare providers.

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: 08717648152115 Part Number: 1012454-15 Lot Numbers: 90819G1 90927G1 90819G2 90930G1 90916G1 91031G1 90916G2

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