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U.S. Department of Health and Human Services

Class 1 Device Recall Cardiosave Hybrid IntraAortic Balloon Pump (IABP)

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 Class 1 Device Recall Cardiosave Hybrid IntraAortic Balloon Pump (IABP)see related information
Date Initiated by FirmJune 05, 2023
Date PostedJuly 19, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2149-2023
Recall Event ID 92287
510(K)NumberK181122 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductCardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
Code Information All Unit Serial Numbers Model UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 0998-00-0800-33 10607567109008 0998-00-0800-34 10607567111940 0998-00-0800-35 10607567109107 0998-00-0800-45 10607567108421 0998-00-0800-52 10607567108438 0998-00-0800-53 10607567108391 0998-00-0800-55 10607567108414 0998-00-0800-65 10607567113432
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information ContactMarylou Insinga
973-709-7442
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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
Quantity in Commerce9174 (4586 US; 4588 OUS)
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DSP
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