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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 Firm June 05, 2023
Date Posted July 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2151-2023
Recall Event ID 92335
510(K)Number K181122  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave 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 Contact Marylou Insinga
973-709-7442
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action 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 RES 92287) Issue 2 - Unexpected shutdown (Covered by this RES event) User Actions: Issue 2: Unexpected Shutdown due to failure of Tantalum Capacitors. Should loss of power occur, therapy will be interrupted and the console will need to be exchanged with another (if available) to resume therapy. If your device remains inoperable, please contact your service representative. It is recommended for users to have an alternate IABP on hand in the event that this issue may occur. 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 Commerce 9174 (4586 US; 4588 OUS) in total
Distribution 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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DSP and Original Applicant = Datascope Corp.
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