Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
- Company
- Datascope Corp.
- Recall Initiated
- June 5, 2023
- Posted
- July 19, 2023
- Recall Number
- Z-2150-2023
- Quantity
- 9174 (4586 US; 4588 OUS)
- Firm Location
- Mahwah, NJ
Reason for Recall
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: ALBANIA ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, 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
Lot / Code Info
All Unit Serial Numbers Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449
Root Cause
Device Design
Action Taken
On June 5, 2023, the firm notified customers of the recall via "URGENT MEDICAL DEVICE CORRECTION" letters. Letters covered two issues: Issue 1 - Failure to charge battery (Covered by this RES event) Issue 2 - Unexpected shutdown (Covered by RES 92335) User Actions: Issue 1: IABP will not charge battery due to failure of the Power Management Board Charge Path Circuitry To prevent electrical surges that may impair the Cardiosave s ability to charge batteries, do not remove the battery from a Cardiosave when the battery level is at 80% or higher and actively charging (i.e successfully connected to AC power). Keep the battery in the charging bay until fully charged. The firm is developing a hardware correction to address this issue. If you have any questions, please contact your Datascope/Getinge representative or call Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. ET