Home / Recalls / Abbott Vascular / Z-1133-2020

Z-1133-2020 Class I Terminated

Recalled by Abbott Vascular — Temecula, CA

FDA device recall Z-1133-2020 was initiated by Abbott Vascular on January 29, 2020 and is designated Class I. Reason for recall: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. The recall status is terminated (terminated April 16, 2024). Affected quantity: Total 39687 NC TREK units (13891 US and 25796 OUS).

Recall Details

Product Type: Devices
Report Date: February 26, 2020
Initiation Date: January 29, 2020
Termination Date: April 16, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Total 39687 NC TREK units (13891 US and 25796 OUS)

Product Description

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) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Reason for Recall

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

Distribution Pattern

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 Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

Code Information

Device Identifier/GTIN: 08717648152092 Part Number: 1012454-08 Lot Numbers: 90801G1 90925G1 90812G1 91010G2 90818G1 91022G1 90818G2 91025G1 90904G1 91101G1 90912G1

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