Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential unexpected shutdowns from capacitor failures, which could interrupt life-saving therapy.
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps with model numbers 0998-00-0800-31 to 0998-00-0800-65 and 0998-UC-0800-31 to 0998-UC-0800-53. This recall is because faulty tantalum capacitors in the pump's power and solenoid boards may cause unexpected shutdowns, interrupting critical therapy for patients with heart conditions.
The pump's power management board and solenoid board contain tantalum capacitors that can fail unexpectedly. This failure may cause the pump to shut down abruptly, interrupting life-saving therapy for patients with heart conditions who rely on continuous support.
Patients using the Cardiosave Hybrid Intra-Aortic Balloon Pump for heart support are most at risk. The device is typically used in hospitals or by medical professionals during critical cardiac procedures.
Check your pump's model number on the device or its packaging. The affected models include 0998-00-0800-31 through 0998-00-0800-65 and 0998-UC-0800-31 through 0998-UC-0800-53. Note that some models are not distributed in the U.S.
Look for the model number on the pump or its packaging to confirm if it is affected.
Reach out to Datascope Corp. for guidance on next steps if your pump is affected.
The pump's power management board and solenoid board contain tantalum capacitors that can fail unexpectedly, potentially causing the pump to shut down and interrupt life-saving therapy.
Models 0998-00-0800-31 through 0998-00-0800-65 and 0998-UC-0800-31 through 0998-UC-0800-53. Note that some models are not distributed in the U.S.
The recall does not require immediate discontinuation; however, affected pumps should be checked 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-2151-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2151-2023 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.
