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Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part… recallZ-2436-2023 · 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 reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.

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. Gas Loss & Gas Gain 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) affected by this correction in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. The following actions should be taken should you experience an alarm for Gas Loss in IAB & Gas Gain in IAB : Gas Gain in IAB Circuit " Verify all of the tubing connections are leak free. " Press the START key to initiate an Autofill and resume pumping. Gas Loss in IAB Circuit " Inspect the tubing from the patient through to the connection of the helium extender tubing to the female luer port of the Cardiosave IABP. " If any blood is noted or perforation is suspected, the following procedure must be performed immediately: 1. Disconnect the catheter extender tubing from the IABP console to allow the balloon to deflate. 2. Clamp extracorporeal tubing between white y-fitting and male connector. 3. Place patient in Trendelenburg as tolerated to guide any residual helium to travel away from the head vessels. 4. Notify physician, and prepare for IAB catheter removal. 5. Consider IAB catheter replacement, if the patient s condition warrants. 6. If blood is suspected of having entered the pump, take pump out of service. It should be evaluated before use in another patient by a Getinge or Biomed/Technical Service representative who has been trained on Cardiosave service requirements, to determine if replacement of contaminated components is necessary. " If blood is not detected, ensure that the IAB extender tubing is tightly connected to the IAB and the IABP. If appropriate, perform an Autofill by pressing and holding the IAB FILL key for 2 seconds, then press the START key to resume pumping. " If the patient is febrile or tachycardic, consider increasi

Recall details

Recall number
Z-2436-2023
Status
Open, Classified
Initiated by the company
Jul 31, 2023
Posted by the FDA
Aug 30, 2023
Recalling firm
Datascope Corp.
Quantity
9175 units
Product code
DSP
FDA submissions
K181122
Distribution
Worldwide - US Nationwide 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 92491).

Sources and updates

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