Home / Recalls / Datascope Corporation / Z-1685-2022

Z-1685-2022 Class II Ongoing

Recalled by Datascope Corporation — Fairfield, NJ

FDA device recall Z-1685-2022 was initiated by Datascope Corporation on August 5, 2022 and is designated Class II. Reason for recall: Certain lots containing undersized dilator. The recall status is ongoing. Affected quantity: 10,427 units.

Recall Details

Product Type: Devices
Report Date: September 14, 2022
Initiation Date: August 5, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,427 units

Product Description

MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

Reason for Recall

Certain lots containing undersized dilator.

Distribution Pattern

Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Code Information

Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01.

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-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-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-2837-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P (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-2839-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 06 (July 27, 2020)
Z-2844-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Ja (July 27, 2020)
Z-2841-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Ki (July 27, 2020)