CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
- Company
- Datascope Corp.
- Recall Initiated
- August 8, 2024
- Posted
- September 20, 2024
- Recall Number
- Z-3136-2024
- Quantity
- 5,475 units
- Firm Location
- Mahwah, NJ
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.
Distribution
International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.
Lot / Code Info
Product No. 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65; UDI: 10607567109053, 10607567111117, 10607567109008, 10607567111940, 10607567109107, 10607567114187, 10607567108421, 10607567108438, 10607567108391, 10607567108414, 10607567113432; Lot No. ALL LOTS.
Root Cause
Software design
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