Datascope recalls CS300 Intra-Aortic Balloon Pump models with battery run time risk if maintenance isn't followed. Affected units may not operate as intended.
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Datascope is recalling CS300 Intra-Aortic Balloon Pumps that may not run long enough if battery maintenance isn't done as instructed. This could affect medical use where consistent power is critical.
The battery may not provide enough power for the required operation time if maintenance isn't performed correctly. This could lead to the pump failing during critical medical procedures.
Healthcare professionals using the CS300 Intra-Aortic Balloon Pump for cardiovascular procedures are most at risk. Patients receiving this device may also be affected if the pump fails during use.
Check for the model number 0998-00-3023-53 on the pump. The device is designed for cardiovascular use and operates on 110V power.
Ensure battery maintenance is performed according to the manufacturer's instructions to maintain proper run time.
The recall is for healthcare professionals using the device. Patients are not directly affected unless the device fails during use.
Check for the model number 0998-00-3023-53 on the pump. The device is designed for cardiovascular use and operates on 110V power.
Ensure battery maintenance is performed as instructed to maintain proper run time. No immediate action is required beyond following the maintenance steps.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1943-2019 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1943-2019 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.
