CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reported: October 2, 2024 Initiated: August 8, 2024 #Z-3134-2024
Product Description
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason for Recall
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.
Details
- Recalling Firm
- Datascope Corp.
- Units 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, 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.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.. Recalled by Datascope Corp.. Units affected: 5,475 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Critical. Recall number: Z-3134-2024.
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