Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific model numbers due to potential helium regulator failure causing leaks and insufficient helium in the pump reservoir.
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 three specific models of Cardiosave Rescue Intra-Aortic Balloon Pumps because their helium regulator may fail, leading to helium leaks and insufficient helium in the pump reservoir. This could affect medical use if the pump isn't properly replenished during operation.
The helium regulator in the pump may fail, causing a leak that prevents the pump's internal helium reservoir from being replenished when connected to the hospital cart. This could lead to insufficient helium during critical medical procedures.
Healthcare professionals using the Cardiosave pumps in hospitals are most at risk, particularly those handling the specific model numbers listed in the recall.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump. These models were sold with specific serial numbers and UDI-DI identifiers listed in the recall notice.
Identify the pump model number to confirm if it is one of the recalled models: 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
The high pressure helium regulator may fail, causing a helium leak that prevents the pump's internal reservoir from being replenished when docked into the hospital cart, potentially leading to insufficient helium during use.
Check the model number on your pump; if it is 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85, it is affected.
The recall record does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1230-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1230-2023 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.
