Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific part numbers due to risk of unexpected pump stops during use. Affected units may require replacement.
Users were identifying autofill failure conditions on the devices causing pump stops.
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps with certain part numbers because users may experience unexpected pump stops. This could lead to medical complications if the pump fails during critical cardiac support.
The pumps may stop unexpectedly due to autofill failure conditions. This can disrupt critical cardiac support and potentially cause medical complications if the pump fails during use.
Healthcare professionals using these pumps for cardiac support are most at risk. Patients receiving this life-saving treatment could be affected if the pump stops unexpectedly.
Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85. The unique device identifiers (UDIs) listed are 10607567112312, 10607567108407, and 10607567113449.
Identify the part number on your pump to see if it matches the recalled models: 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
Reach out to Datascope Corp. for guidance on next steps if your pump is affected.
The pumps may stop unexpectedly due to autofill failure conditions, which could disrupt critical cardiac support.
Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85. The unique device identifiers (UDIs) listed are 10607567112312, 10607567108407, and 10607567113449.
Contact Datascope Corp. for guidance on next steps if your pump is affected.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2438-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2438-2023 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.
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.
