Class 2 Device Recall Cardiosave Rescue

• Date Initiated by Firm: July 31, 2023
• Date Posted: August 31, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2487-2023
• Recall Event ID: 92489
• 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 experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Fiber Optic Damage 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. Fiber optics assists in the rapid acquisition and accuracy of the arterial pressure waveform although it is not required to provide therapy with a fiber optic catheter. As detailed within the IFU and educational guides, the patient s arterial pressure can also be obtained via the catheter s inner lumen by connecting a standard fluid-filled pressure bag system or by connecting an external arterial pressure source (typically a radial or femoral arterial line) to the IABP console. Despite the ability of using fiber optics for pressure monitoring, the IFU continues to advise maintenance of the catheter s inner lumen. This guidance is provided within the IFU and Operating guides to both prevent thrombus formation at the end of the catheter, as well as to maintain the integrity of the inner lumen despite the use of the fiber optic signal for monitoring. This provides an alternative source for guiding the therapy if the fiber optic signal is lost. Using AUTO Mode and the ECG as Trigger If in Semi-AUTO MODE and using the fiber optic signal as the trigger source and the signal is not available, utilizing AUTO mode will automatically select the ECG or other available trigger source to guide therapy. When in AUTO mode should the fiber optic signal be lost, therapy can still be safely delivered using only the ECG. However, should the ECG not be a reliable or accurate signal, and the system seeks the arterial signal to guide therapy, the IABP will not have the information needed to guide therapy, and therapy is stopped. Should no alternative arterial pressure source be available, the hospital
• Quantity in Commerce: 9175 units
• Distribution: US Nationwide. Global 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.