Abbott Vascular: NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM 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 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM 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 08717648152061

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

What happened

Abbott Vascular is recalling 39,687 NC TREK RX Coronary Dilatation Catheters (13,891 units in the US and 25,796 units outside the US) distributed worldwide. The catheters, which are used for balloon dilatation of coronary arteries, may exhibit difficulty or inability to deflate the balloon. The affected devices have part number 1012453-12 and specific lot numbers including 90730G1, 90919G1, 90731G1, 90927G1, 90818G1, 91001G1, 90822G1, 91015G1, 90905G1, 91025G1, 90918G1, and 91101G1.

The recall was issued because of the potential for the balloon to not deflate properly during use. The source document does not specify a remedy or corrective 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: 08717648152061 Part Number: 1012453-12 Lot Numbers: 90730G1 90919G1 90731G1 90927G1 90818G1 91001G1 90822G1 91015G1 90905G1 91025G1 90918G1 91101G1

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