Home / Recalls / Datascope Corporation / Z-2164-2017

Z-2164-2017 Class II Terminated

Recalled by Datascope Corporation — Fairfield, NJ

Recall Details

Product Type
Devices
Report Date
May 31, 2017
Initiation Date
April 12, 2017
Termination Date
January 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
996 UNITS

Product Description

SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.

Reason for Recall

Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.

Distribution Pattern

Nationwide

Code Information

300004515, 3000043376 3000040272 3000038372 added lot numbers: 3000043374 and 3000045513

Other recalls by Datascope Corporation

  • Z-1687-2022 Class II — Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter (August 5, 2022)
  • Z-1685-2022 Class II — MEGA 8Fr 50cc Intra-Aortic Balloon Catheter (August 5, 2022)
  • Z-1686-2022 Class II — Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter (August 5, 2022)
  • Z-0131-2023 Class II — LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra (August 5, 2022)
  • Z-2837-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P (July 27, 2020)
  • Z-2839-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 06 (July 27, 2020)
  • Z-2841-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Ki (July 27, 2020)
  • Z-2836-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Ki (July 27, 2020)
  • Z-2843-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Ja (July 27, 2020)
  • Z-2842-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - (July 27, 2020)