Home / Recalls / Abbott Vascular / Z-1132-2020

Z-1132-2020 Class I Terminated

Recalled by Abbott Vascular — Temecula, CA

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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  • Z-0732-2025 Class II — 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascul (November 6, 2024)
  • Z-0731-2025 Class II — 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular (November 6, 2024)
  • Z-0730-2025 Class II — 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conj (November 6, 2024)
  • Z-0117-2023 Class II — Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 C (September 8, 2022)
  • Z-0115-2023 Class II — Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 C (September 8, 2022)
  • Z-0116-2023 Class II — Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR (September 8, 2022)
  • Z-1095-2022 Class I — Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 (March 30, 2022)
  • Z-0921-2022 Class II — 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) (March 11, 2022)
  • Z-0923-2022 Class II — 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) (March 11, 2022)