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

• Date Initiated by Firm: December 19, 2022
• Date Posted: January 19, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0886-2023
• Recall Event ID: 91179
• 510(K)Number: K181122
• Product Classification: System, balloon, intra-aortic and control - Product Code DSP
• Product: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
• Code Information: All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-75, 10607567112312; 0998-UC-0800-83, 10607567108407; 0998-UC-0800-85, 10607567113449.
• Recalling Firm/ Manufacturer: Datascope Corp.; 1300 Macarthur Blvd; Mahwah NJ 07430-2052
• For Additional Information Contact: Megan Ties; 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: Device Design
• Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 12/19/2022 was sent to customers. It contains 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 include to examine inventory immediately to determine if affected units are on hand, if a blood back event is suspected, remove the Cardiosave from patient use, and report the event to appropriate biomedical engineering staff for inspection prior to next patient use, and ensure that all Cardiosave Intra-Aortic Balloon Pump users at your facility are aware of this notice. Customers were also instructed to sign and return the MEDICAL DEVICE CORRECTION - RESPONSE FORM and notify customers if affected units were further distributed. The Cardiosave IABP units distributed going forward will be added to the scope and newly affected consignee(s) will be notified of the field correction. Letter dated 11/21/23 titled THIS IS AN UPDATE TO THE PREVIOUSLY INITIATED ACTION URGENT MEDICAL DEVICE CORRECTION was sent to customers. This notification is an update to the previously initiated action, dated December 19, 2022, regarding potential for blood to enter into the Cardiosave Hybrid and Rescue IABPs. The update is primarily to share new recommendations, such as a new labeling addendum and to consider the benefits and risks of using Cardiosave IABP on a patient during transport. Instructions were the same as the first letter. Updated letters will be sent to OUS consignees, beginning on 07/31/2025 alerting consignees of an upcoming component correction and software update to resolve the previous issues. Letters will be distributed as approval is received for each country. Once approval is received in the US, US consignees will be notified.
• Quantity in Commerce: 46 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