Datascope recalls Cardiosave Rescue Model 0998-00-0800-83 due to helium leaks from damaged O-rings causing therapy interruptions. Affected units may need repair or replacement.
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 Rescue pump consoles with model number 0998-00-0800-83 because worn or torn O-rings can cause helium leaks, interrupting therapy. This could lead to interrupted medical treatment if the helium supply runs out.
Damaged, worn, or torn O-rings in the quick disconnect fitting can cause helium leaks. If the helium supply is depleted, the device may stop providing therapy, interrupting medical treatment.
Users of Cardiosave Rescue devices with the specified model number are affected. Patients relying on this device for medical therapy are at risk of interrupted treatment.
Check for the model number 0998-00-0800-83 on the device. The recall includes all units with this specific model number and serial numbers.
Inspect the quick disconnect fitting for signs of worn, torn, or damaged O-rings.
Reach out to Datascope Corp. for guidance on repairing or replacing the device if needed.
Datascope has received reports of damaged, worn, or torn O-rings on the quick disconnect fitting, which can cause helium leaks and interrupt therapy.
Check for damaged O-rings and contact Datascope Corp. for repair or replacement options.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1232-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1232-2023 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.