Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific model numbers due to potential unexpected shutdowns from capacitor failures, which may interrupt 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 Rescue Intra-Aortic Balloon Pumps with model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. These devices may unexpectedly shut down due to capacitor failures, risking interruption of life-saving therapy.
The IABP may unexpectedly shut down because of failures in the tantalum capacitors on the Power Management Board or Solenoid Board. This interruption could stop life-saving therapy for patients needing cardiac support.
Healthcare professionals using the Cardiosave Rescue IABP for cardiac support are most at risk. Patients receiving this device during critical medical procedures could experience therapy interruption.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the device. The unit serial numbers match the listed UDI codes: 10607567112312, 10607567108407, or 10607567113449.
Identify the model number on the device to confirm if it matches the recalled models: 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
Reach out to Datascope Corp. for guidance on next steps if the device is recalled.
The Cardiosave Rescue IABP may unexpectedly shut down due to failures in the tantalum capacitors on the Power Management Board or Solenoid Board, which could interrupt life-saving therapy.
Model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 are affected.
The recall does not require immediate stop use; healthcare professionals should monitor for unexpected shutdowns and contact Datascope 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-2152-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2152-2023 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.
