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U.S. Department of Health and Human Services

Class 1 Device Recall Cardiosave Hybrid

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 Class 1 Device Recall Cardiosave Hybridsee related information
Date Initiated by FirmFebruary 07, 2023
Date PostedMarch 09, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1145-2023
Recall Event ID 91602
510(K)NumberK112372 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductCardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, 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
Code Information All serial numbers. Model 0998-00-0800-31, UDI-DI 10607567109053; Model 0998-00-0800-32, UDI-DI 10607567111117; Model 0998-00-0800-33, UDI-DI 10607567109008; Model 0998-00-0800-34, UDI-DI 10607567111940; Model 0998-00-0800-35, UDI-DI 10607567109107; Model 0998-00-0800-45, UDI-DI 10607567108421; Model 0998-00-0800-52, UDI-DI 10607567108438; Model 0998-00-0800-53, UDI-DI 10607567108391; Model 0998-00-0800-55, UDI-DI 10607567108414; Model 0998-00-0800-65, UDI-DI 10607567113432
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information ContactMs. Allison Jean Kaplan
973-709-7779
Manufacturer Reason
for Recall		An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 2/7/23 to customers. The customers were instructed to do the following actions: Examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. Prior to use of the Cardiosave IABP, inspect the coiled cable cord to ensure that there is no visible damage. Should you experience an unexpected shutdown of the Cardiosave IABP during therapy, or a present frozen or black screen, utilize another IABP to continue therapy. Until an alternative IABP is located you may attempt to restart the IABP. If the IABP remains non-operational, immediately remove from the patient care environment for further product evaluation. During Installation and Replacement of the Helium Tank per the Cardiosave Operating Instructions, please ensure care is taken not to damage the helium tank or the helium tank yoke while inserting and/or removing the helium tank. Follow the instructions for use when changing the helium tank. If user observes any visual damage to the O-ring installed as part of the quick disconnect fitting, contact your Datascope/Getinge service representative. If your device remains inoperable, please contact your service representative to identify the cause and take the necessary actions required. Complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM to acknowledge that you have received and understand this notification. Return the completed form to Datascope/Getinge by e-mailing a scanned copy to cardiosave-sdhl23.act@getinge.com or by faxing the form to 1-877-660-5841. 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. (Eastern Time Zone). Type of Action by the Company: Datascope/Getinge has developed a hardware correction to address this issue. It is important to note that this i
Quantity in Commerce4062 Total
DistributionWorldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GHANA, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, TURKMENISTAN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, AND YEMEN.
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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