Class 1 Device Recall Cardiosave Rescue

• Date Initiated by Firm: July 31, 2023
• Date Posted: August 30, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2438-2023
• Recall Event ID: 92480
• 510(K)Number: K181122
• Product Classification: System, balloon, intra-aortic and control - Product Code DSP
• Product: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
• Code Information: All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
• Recalling Firm/ Manufacturer: Datascope Corp.; 1300 Macarthur Blvd; Mahwah NJ 07430-2052
• For Additional Information Contact: Allison Jean Kaplan; 973-709-7779
• Manufacturer Reason for Recall: Users were identifying autofill failure conditions on the devices causing pump stops.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT MEDICAL DEVICE CORRECTION dated 7/31/23 was sent to customers. Autofill Alarms User Actions to be taken now: Our records indicate that you may have a Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. As a result of the investigation into the complaints, Getinge would like to reinforce information that is detailed in the Cardiosave Instructions for Use to help minimize the frequency and impact of these alarms: As per the Cardiosave Operating Instructions in sections 2.1.8, Initiation of Assist and 2.1.9, IAB Fill ; the system performs an autofill under the following three conditions: " Initiation of Therapy " Every two (2) hours while therapy is ongoing " If during transport, the atmospheric pressure changes by a 25 mmHg (~1,000 ft.) rise or 50 mmHg (~2,000 ft.) drop during therapy to keep the balloon pressure acclimated to local conditions If the autofill procedure fails to purge and fill the Pneumatic Module properly, the message Autofill Failure will be displayed, an audible alarm will be activated, and pumping will be suspended until the alarm is cleared. Corrective action can be obtained by pressing the Help Available key. The three high priority alarms are: " Autofill Failure No Helium " Autofill Failure Blood Suspected " Autofill Failure Note: Autofill Failure Blood Suspected is caused by a leak in the IAB which results in blood migration back into the IABP system. The failure of the IAB is outside of the scope of this Field Safety Notification. Autofill Failure No Helium " Verify that the Cardiosave device has sufficient Helium in the system. " If the Cardiosave is in Hybrid mode (console within a hospital cart), verify the external Helium Tank is connected to the cart, is opened, and there is sufficient Helium in the tank to support the IABP therapy. " If the Cardiosave is in Rescue
• Quantity in Commerce: 9175 units
• Distribution: Worldwide - US Nationwide distribution.
• 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.