Datascope recalls Cardiosave Rescue devices with model 0998-00-080: IFU addendum updates vibration/shock table standards. All units affected.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Datascope is recalling all Cardiosave Rescue devices with model 0998-00-0800-83. The recall is due to an update in the user manual that references correct vibration and shock table standards.
The recall involves an update to the user manual (IFU) that references correct vibration and shock table standards. This update ensures the device meets safety standards for vibration and shock testing.
All owners of Cardiosave Rescue devices with model 0998-00-0800-83 are affected. Healthcare professionals using the device are most at risk.
Check for the model number 0998-00-0800-83 on your Cardiosave Rescue device. All units produced are affected by this recall.
Check the IFU addendum for updated vibration and shock table standards.
No, the recall is a minor update to the user manual for safety standards. It does not pose a risk to users.
No, the recall does not require stopping use. The update is for the user manual to reference correct standards.
Review the user manual for the updated vibration and shock table standards as part of the recall.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0932-2026 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0932-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
