Home / Recalls / Abbott Vascular / Z-1144-2020

Z-1144-2020 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 791 Traveler (0 US and 791 OUS)

Product Description

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

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: 08717648196034 Part Number: 1013158-12 Lot Numbers:90813G1

Other recalls by Abbott Vascular

  • Z-0733-2025 Class II — 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular proc (November 6, 2024)
  • 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)