Datascope recalls CS100 Intra-Aortic Balloon Pumps with serial numbers 0998-00-3013-55 due to potential battery run time issues. Revised labeling and training are provided to address the risk.
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
Datascope is recalling CS100 Intra-Aortic Balloon Pumps with serial number 0998-00-3013-55 because improper battery maintenance could lead to insufficient power. This affects medical devices used in cardiovascular procedures.
The battery may not provide enough power if maintenance isn't done properly, which could lead to the device stopping working during critical medical procedures. This is a risk specific to the device's operation in cardiovascular settings.
Healthcare professionals using the CS100 Intra-Aortic Balloon Pump for cardiovascular procedures are most at risk if battery maintenance is not done correctly.
Check the serial number on the device, which is 0998-00-3013-55 for the recalled model. The device is designed for cardiovascular use and operates on 220V power.
Ensure battery maintenance is performed correctly to maintain the minimum required run time.
This recall specifically affects CS100 Intra-Aortic Balloon Pumps with serial number 0998-00-3013-55.
Ensure battery maintenance is performed correctly to maintain the minimum required run time.
Revised labeling and training are provided to address the risk, but no specific replacement is mentioned.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1942-2019 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1942-2019 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.
