Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-2152-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Product Classification:

Class I

Date Initiated: June 5, 2023

Date Posted: July 26, 2023

Recall Number: Z-2152-2023

Event ID: 92335

Reason for Recall:

An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.

Status: Ongoing

Product Quantity: 9174 (4586 US; 4588 OUS) in total

Code Information:

All Unit Serial Numbers Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449

Distribution Pattern:

Worldwide Distribution- US (Nationwide) and OUS (foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, AZERBAIJAN , BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, C¿te d'Ivoire, CROATIA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GHANA, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM, YEMEN, ZAMBIA

Voluntary or Mandated:

Voluntary: Firm initiated