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Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part… recallZ-2487-2023 · Datascope Corp. · initiated Jul 31, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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-2487-2023
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 Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Code information (models, lots, serial numbers)

All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449

Devices named in this recall

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

Other products in the same recall event

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

Sources and updates

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