CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

FDA device recall Z-3136-2024 · posted 2024-09-20 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

Reason for recall

Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.

Action taken

Consignees were mailed an URGENT FIELD SAFETY NOTICE dated 8/5/2024. This notification informs consignees of the deployment of previously installed software to mitigate previously identified issues in Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump devices. Consignees are asked to examine their inventory immediately to identify if they have any Cardiosave Hybrid and/or Rescue IABP devices, and to identify what software version is currently installed in devices. Devices with software revision D.00 or D.01 have been corrected. If consignee units have a software version lower than D.00 or D.01 (e.g.: B.XX or C.XX) the device still requires the software update and has not yet been corrected. If consignee units do not have the corrected software revision installed, they are to continue

Root cause

Software design

Status

Open, Classified

Product code

DSP

Quantity affected

5,475 units

Distribution

International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GE

Date initiated

2024-08-08

Date posted

2024-09-20

Location

Mahwah, NJ

Related 510(k) clearances