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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 December 19, 2022
Date Posted January 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-0885-2023
Recall Event ID 91179
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-UC-0800-55
Code Information All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-00-0800-33, 10607567109053; 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; 0998-UC-0800-31, no UDI; 0998-UC-0800-33, no UDI; 0998-UC-0800-52, no UDI; 0998-UC-0800-53, no UDI; 0998-UC-0800-55, no UDI.
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Ms. Marylou Insinga
973-709-7442
Manufacturer Reason
for Recall		 The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
FDA Determined
Cause 2		 Device Design
Action An URGENT MEDICAL DEVICE CORRECTION notification letter dated 12/19/22 was sent to customers. It contains IMMEDIATE CLINICAL GUIDANCE to augment current clinical recommendations of patient management strategies should an IAB perforation occur. Maintain established patient and device management strategies regarding timing to IAB catheter removal. User Actions to be taken: . Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. . If a blood back event is suspected, remove the Cardiosave from patient use, and report the event to appropriate biomedical engineering staff for inspection of the safety disk prior to next patient use. . Ensure that all Cardiosave Intra-Aortic Balloon Pump users at your facility are aware of this notice and actions to perform. . Distribute the clinical guidance to users per your institution policy. . Complete and sign the MEDICAL DEVICE CORRECTION - RESPONSE FORM to acknowledge that you have received this notification. Return the form to Datascope/Getinge by e-mail to cardiosavebloodback2022.act@getinge.com or fax 1-877-690-5160. . If you are a distributor who has shipped any affected products to customers, forward this letter to their attention for appropriate action. If you have any questions, please contact your Datascope/Getinge representative or call the 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). The Cardiosave IABP units distributed going forward will be added to the scope of the recall. Newly affected consignee(s), not initially within the scope of the field correction, will be notified of the field correction.
Quantity in Commerce 8759 Total
Distribution Worldwide Distribution - US Nationwide and the countries of Albania, 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, Reunion, 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, Vietnam, Yemen, and 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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