Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential unexpected shutdown from blood entering the device during therapy with a compromised catheter.
The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Datascope is recalling certain Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) models because they may shut down unexpectedly if blood enters the device while using a compromised catheter. This could lead to treatment interruptions for patients needing cardiac support.
The device may shut down unexpectedly when blood enters the pump during therapy with a catheter that is not properly functioning. This could interrupt life-saving cardiac support for patients with heart conditions.
Patients using the recalled Cardiosave IABP devices for cardiac support are most at risk. Healthcare providers who use these devices in medical settings may also be 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. The device may also be designated as part number D998.
Identify the model number on your Cardiosave IABP device to confirm if it is in the recalled list.
Reach out to Datascope Corp. for guidance on next steps if your device is affected.
The Cardiosave IABP may shut down unexpectedly due to blood entering the device when therapy is provided with a compromised intra-aortic balloon catheter.
Model numbers 0998-00-0800-31 through 0998-00-0800-65 and 0998-UC-0800-31 through 0998-UC-0800-65 are affected. All serial numbers are also included.
The recall does not require immediate stop use; however, affected users should check with Datascope Corp. for guidance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0885-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0885-2023 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.
