Datascope recalls specific Cardiosave Hybrid Intra-Aortic Balloon Pumps due to gas circuit alarms triggered by patient movement like coughing or swallowing, which could cause incorrect therapy alerts.
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, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.
Datascope is recalling certain Cardiosave Hybrid Intra-Aortic Balloon Pumps after reports of gas circuit alarms. These alarms can be triggered by normal patient movements such as coughing or swallowing, potentially leading to incorrect therapy alerts.
The pumps can trigger false gas circuit alarms when patients move, cough, swallow, or have blood in the tubing. This may cause the pump to stop therapy unexpectedly, which could be harmful for patients with heart conditions.
Patients using these pumps for heart support, especially those who move frequently or have conditions that cause coughing/swallowing. Healthcare providers managing these patients are most at risk.
Check for part numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, or similar listed in the recall. Also look for the unique device identifiers (UDIs) provided in the record.
Identify your pump model by checking the part number or unique device identifier (UDI) on the pump or packaging.
Check if your pump has triggered gas circuit alarms, especially during patient movement like coughing or swallowing.
Datascope identified that patient movement such as coughing or swallowing can trigger false gas circuit alarms in these pumps, which may cause incorrect therapy alerts.
Check your pump model and unique device identifier (UDI) to see if it's in the recall list. If it is, monitor for gas circuit alarms and contact Datascope for further instructions.
Yes, but you should be aware that patient movement may trigger false alarms. If alarms occur, contact Datascope for guidance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2435-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2435-2023 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.
