Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part… recallZ-2486-2023 · Datascope Corp. · initiated Jul 31, 2023

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number

Z-2486-2023

Status

Open, Classified

Initiated by the company

Jul 31, 2023

Posted by the FDA

Aug 31, 2023

Recalling firm

Datascope Corp.

Quantity

9379 units

Product code

DSP

FDA submissions

K181122

Distribution

US Nationwide. Global Distribution.

Product description

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

Devices named in this recall

13 devices in the FDA device registry whose identifier appears in the recall's code information.

• CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls39 deaths10,316 reports
• CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls8 deaths1,686 reports
• CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls5 deaths1,181 reports
• CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls2 deaths1,157 reports
• CARDIOSAVE RESCUE 0998-00-0800-83

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  26 recalls167 reports
• CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls3 deaths456 reports
• CARDIOSAVE HYBRID TYPE I (AU) 0998-00-0800-31

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls232 reports
• CARDIOSAVE HYBRID TYPE D PLUG 0998-00-0800-33

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls2 deaths230 reports
• CARDIOSAVE HYBRID TYPE J PLUG 0998-00-0800-32

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls2 deaths48 reports
• CARDIOSAVE RESCUE, CHINESE 0998-00-0800-75

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls12 reports
• CARDIOSAVE RESCUE, 3.1 EDITION 0998-00-0800-85

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls1 report
• CARDIOSAVE HYBRID TYPE M PLUG 0998-00-0800-35

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls13 reports
• CARDIOSAVE HYBRID TYPE K PLUG 0998-00-0800-34

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  15 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92489).

• Z-2487-2023 · Open, Classified
  Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85