Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to damaged O-rings causing helium leaks that may interrupt therapy. Affected units include D998-00-0800-31 to D998-UC-0800-55.
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps with certain model numbers because worn or torn O-rings can cause helium leaks. If the helium supply runs out, the medical therapy stops, which could be dangerous for patients using the device.
Damaged, worn, or torn O-rings in the quick disconnect fitting can cause helium leaks from the pump. If the helium supply is depleted, the therapy stops, which could lead to complications for patients relying on the device.
Patients using the Cardiosave Hybrid Intra-Aortic Balloon Pump with the listed model numbers are most at risk. The device is used for critical medical therapy, so affected individuals should take action immediately.
Check the model number on your Cardiosave Hybrid pump. Affected units have model numbers starting with D998-00-0800 or D998-UC-0800, specifically D998-00-0800-31 through D998-UC-0800-55 as listed in the recall notice.
Look for the model number on your pump, which should be one of the listed numbers starting with D998-00-0800 or D998-UC-0800.
Reach out to Datascope Corp. to confirm if your pump is affected and get instructions for next steps.
Datascope has received reports of damaged, worn, or torn O-rings on the quick disconnect fitting, which can cause helium leaks and interrupt therapy if the helium supply runs out.
The affected model numbers are D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, and D998-UC-0800-55.
Check your pump's model number against the list provided in the recall. Contact Datascope Corp. to confirm if your pump is affected and get instructions for next steps.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1231-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1231-2023 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.
