Home / Recalls / Datascope Corporation / Z-1710-2018

Z-1710-2018 Class II Terminated

Recalled by Datascope Corporation — Fairfield, NJ

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
October 19, 2017
Termination Date
April 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752

Reason for Recall

The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

Distribution Pattern

Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

Code Information

Lot 3000056255

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-2842-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - (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-2845-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Jap (July 27, 2020)