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Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model… recallZ-1229-2023 · Datascope Corp. · initiated Feb 7, 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

There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.

FDA root cause category: Under Investigation by firm

What the company is doing

URGENT MEDICAL DEVICE CORRECTION dated 2/7/23 were sent to customers. There have been reported failures of the high pressure helium regulator which may cause a helium leak in the Cardiosave Hospital Cart. The high pressure helium regulator is located in the Cardiosave Hospital Cart and regulates the helium pressure of the external helium supply. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir. Please refer to images under Issue 3 for reference. Issue 3: Leak in the High Pressure Helium Regulator Identification of the issue: There have been reported failures of the high pressure helium regulator which may cause a helium leak in the Cardiosave Hospital Cart. The high pressure helium regulator is located in the Cardiosave Hospital Cart and regulates the helium pressure of the external helium supply. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir. Please refer to images below for reference. Datascope/Getinge has received 51 reported complaints of helium leak as a result of high pressure helium regulator failure over a 2 year period. There have been 0 adverse events reported. Risk to Health: Should a Cardiosave s helium supply be depleted due to an impaired helium pressure regulator, therapy may be interrupted. As with any therapy interruption, the degree of subsequent hemodynamic stability is related to the patient s overall clinical condition, those critically ill are more vulnerable to clinical decline. The risk of therapy interruption from a depleted helium supply is mitigated by the advanced notice provided to the User (a minimum of approximately 24 hours). The Pump Console s internal helium

Recall details

Recall number
Z-1229-2023
Status
Open, Classified
Initiated by the company
Feb 7, 2023
Posted by the FDA
Mar 6, 2023
Recalling firm
Datascope Corp.
Quantity
8909 units
Product code
DSP
FDA submissions
K112372
Distribution
US Nationwide. Global Distribution.

Product description

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

Code information (models, lots, serial numbers)

All Serial Numbers. Model Number: 0998-00-0800-31, UDI-DI:10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-34, UDI-DI: 10607567111940; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number: 0998-00-0800-45, UDI-DI: 10607567108421; Model Number: 0998-00-0800-52, UDI-DI: 10607567108438; Model Number: 0998-00-0800-53, UDI-DI: 10607567108391; Model Number: 0998-00-0800-55, UDI-DI: 10607567108414; Model Number: 0998-00-0800-65, UDI-DI: 10607567113432

Devices named in this recall

10 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 91645).

Sources and updates

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