Datascope recalls CS100 Intra-Aortic Balloon Pumps with serial numbers 0998-00-3013-53 due to potential battery run time issues. Revised labeling and training are provided to address the hazard.
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 offered.
Datascope is recalling CS100 Intra-Aortic Balloon Pumps with specific serial numbers 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 failing during use. This is a risk in medical settings where consistent power is critical for patient safety.
Healthcare professionals using the CS100 Intra-Aortic Balloon Pump for cardiovascular procedures are most at risk if battery maintenance is not followed correctly.
Check the serial number on the device, which is 0998-00-3013-53. The product is an English-language 110V Intra-Aortic Balloon Pump for cardiovascular use.
Ensure battery maintenance is performed correctly to maintain minimum run time.
The product is safe if battery maintenance is performed correctly, but improper maintenance could lead to insufficient power.
Check the serial number; if it matches 0998-00-3013-53, follow the battery maintenance guidelines provided by Datascope.
Yes, revised labeling and training are offered to help users maintain the battery properly.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1941-2019 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1941-2019 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.
