Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential non-compliance with safety standard 60601-1-12:2014 after a software update.
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) with model number 0998-00-0800-55. The recall is because the software update to version D.00 incorrectly stated compliance with a safety standard, which could lead to improper use if the device is not properly regulated.
The software update to version D.00 incorrectly indicated that the device complies with safety standard 60601-1-1-12:2014. This could mean the device does not meet safety requirements, potentially leading to improper function during medical procedures.
Healthcare professionals using Cardiosave IABP devices with model number 0998-00-0800-55 are likely affected. Patients using these devices are at minimal risk if the device is properly maintained.
Check for model number 0998-00-0800-55 on the device. The serial numbers listed are CB286971I8, CB283804G8, CB283867G8, and CB283522G8. The device may also have a UDI-DI code of 10607567108414.
Verify the model number on the device is 0998-00-0800-55.
Reach out to Datascope Corp. for further guidance on the recall.
The recall indicates a potential non-compliance with safety standards after a software update, but the device is not considered immediately dangerous. Healthcare professionals should follow the manufacturer's guidance.
Check the model number and serial numbers listed in the recall. Contact Datascope Corp. for specific instructions.
The recall does not indicate a risk of injury; it is a software compliance issue that may require attention but does not pose an immediate hazard.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1907-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1907-2023 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.
