Company: Datascope Corp.
Date of Enforcement Report: 9/20/2024
Class I
PRODUCT
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Recall Number:
Z-3134-2024
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.
RECALLING FIRM/MANUFACTURER:
Datascope Corp.
VOLUME OF PRODUCT IN COMMERCE:
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
