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

• Date Initiated by Firm: June 05, 2023
• Date Posted: July 19, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2150-2023
• Recall Event ID: 92287
• 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
• Code Information: All Unit Serial Numbers Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449
• 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: 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: Device Design
• 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 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 Commerce: 9174 (4586 US; 4588 OUS)
• Distribution: Worldwide 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 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.