Datascope recalls specific Cardiosave Rescue Intra-Aortic Balloon Pumps due to gas circuit alarms triggered by patient movement, coughing, or swallowing. Affected units have unique part numbers and lot numbers.
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.
Datascope is recalling certain Cardiosave Rescue Intra-Aortic Balloon Pumps because they can trigger gas circuit alarms when patients move, cough, or swallow. This could lead to incorrect therapy settings and potential complications during medical treatment.
The pumps can trigger false gas circuit alarms when patients move, cough, or swallow. This may cause the pump to stop therapy unexpectedly, potentially leading to complications in critical cardiac care situations.
Healthcare providers using the Cardiosave Rescue pumps for cardiac support are most at risk. Patients receiving this therapy may experience alarm interruptions if they move during treatment.
Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85. These pumps were sold with specific lot numbers and unique device identifiers (UDIs) listed in the recall notice.
Review the pump's alarm settings to ensure they are configured for the patient's condition and movement patterns.
Be alert for gas circuit alarms during therapy, especially when patients move, cough, or swallow.
Datascope identified that patient movement, coughing, or swallowing can trigger false gas circuit alarms in these pumps, which may cause unexpected therapy interruptions.
Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85. These specific models were recalled with unique device identifiers (UDIs).
No, but you should monitor for alarms and ensure the pump settings are appropriate for the patient's movements.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2436-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2436-2023 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.
