Datascope recalls Cardiosave Hybrid IntraAortic Balloon Pumps with specific model numbers due to risk of fluid ingress causing system shutdown and unsafe hemodynamic instability.
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Datascope is recalling Cardiosave Hybrid IntraAortic Balloon Pumps with model numbers 0998-00-0800-31 through 0998-00-0800-65. Fluid entering the device could cause electronic short circuits, leading to system shutdown and potentially unsafe blood flow.
Fluid can enter the pump's electronic components, causing short circuits that may shut down the device. This could lead to unstable blood flow, which is dangerous for patients relying on the pump for cardiac support.
Patients using the Cardiosave Hybrid IntraAortic Balloon Pump for cardiac support are affected. Those with the specific model numbers listed are most at risk.
Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 or 0998-UC-0800-31 through 0998-UC-0800-65. All serial numbers are also affected. The pump may also be designated as part number D998.
Identify if your pump has model numbers 0998-00-0800-31 through 0998-00-0800-65 or 0998-UC-0800-31 through 0998-UC-0800-65.
Contact Datascope Corp. for further assistance or to confirm if your pump is affected.
Model numbers 0998-00-0800-31 through 0998-00-0800-65 and 0998-UC-0800-31 through 0998-UC-0800-65 are affected.
Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 or 0998-UC-0800-31 through 0998-UC-0800-65. All serial numbers are also affected.
Contact Datascope Corp. for further assistance or to confirm if your pump is affected.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0336-2022 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0336-2022 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.
