Datascope Corp. Recall 95150
Description: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Datascope Corp. Recall 95150 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3134-2024 |
| Event ID | 95150 |
| Event Description | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. |
| Product Type | 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. |
| Quantity | 5,475 units |
| Recall Reason | Firm has developed a software correction (Revision D.00) 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. |
| Device Classification | 20241002 |
| Device 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. |
| Center Classification Date | 20240920 |
| Recall Initiation Date | 20240808 |
| Recalling Firm | Datascope Corp. |
| Initial Notification | Letter |
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