Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pump systems with updated preventative maintenance schedule to align with June 2:2023 service manual changes.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump systems due to a revised preventative maintenance schedule that aligns with a June 2023 service manual update. This recall does not involve a safety hazard but requires updated maintenance procedures to ensure proper system function.
The recall involves a revised preventative maintenance schedule to match updates from the June 2023 service manual. This ensures the pump system remains functional and safe through proper maintenance procedures. The hazard is not a physical risk but a procedural update to prevent potential system issues.
Healthcare professionals using Cardiosave Rescue systems with model numbers starting with 0998-00-0800-83 or serial numbers matching the listed range are affected. Patients using these pumps are at low risk as the issue is procedural, not a safety hazard.
Check for model number 0998-00-0800-83 or serial numbers listed in the recall notice. All units produced with this model number are affected.
Check the updated preventative maintenance schedule in the service manual to ensure timely maintenance.
No, this recall is for procedural updates to the preventative maintenance schedule and does not involve a safety hazard.
No, the recall does not require stopping use; it only requires following the updated maintenance schedule.
No action is needed beyond reviewing the updated maintenance schedule as the system is safe for use.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0917-2026 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0917-2026 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.
