Datascope recalls specific Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may cause insufficient helium in the pump reservoir during use.
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.
Datascope is recalling certain Cardiosave Hybrid Intra-Aortic Balloon Pump models because their helium regulator can fail, leading to insufficient helium in the pump reservoir when docked with the hospital cart. This could cause the pump to malfunction during medical procedures.
The high pressure helium regulator in the pump can fail, causing a helium leak in the hospital cart. When the pump is docked into the cart, the internal helium reservoir won't replenish properly, potentially leading to insufficient helium for medical use.
Healthcare professionals using the Cardiosave Hybrid Intra-Aortic Balloon Pump in hospitals are most at risk. Patients receiving this pump during medical procedures may be affected if the pump malfunctions.
Check for 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, or 0998-UC-0800-53. All units with these model numbers are affected.
Identify the model number on your Cardiosave Hybrid Intra-Aortic Balloon Pump to see if it is listed in the recall.
Reach out to Datascope Corp. for guidance on next steps if your pump is affected.
The recall affects Cardiosave Hybrid Intra-Aortic Balloon Pump models 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, and 0998-UC-0800-52.
The high pressure helium regulator in the pump can fail, causing a helium leak in the hospital cart and preventing the internal helium reservoir from replenishing when docked.
Check your model number against the list provided in the recall. Contact Datascope Corp. for further instructions.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1229-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1229-2023 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
