Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific part numbers due to reported overheating causing system shutdowns. Affected units may lose pumping function and enter standby mode.
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps with certain part numbers because users reported overheating alarms that can cause the system to stop working or go into standby mode. This could lead to the pump failing during critical medical use.
The pumps can overheat and trigger alarms that cause the system to stop pumping or enter standby mode. This means the device might fail during critical medical procedures when it's needed to support a patient's heart.
Healthcare professionals using Cardiosave pumps for cardiac support are most at risk. Patients receiving this life-saving device may experience pump failure if the recalled units are in use.
Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0999-00-0800-85 on the pump. Also look for the unique device identifier (UDI) listed in the recall notice.
Look for overheating alarms or the pump entering standby mode, which may indicate the device is malfunctioning.
Users reported overheating alarms that can cause the pump to stop working or enter standby mode, potentially leading to failure during critical medical use.
Part numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85, as well as the UC versions with corresponding UDI numbers.
The recall does not require immediate stoppage; healthcare providers should monitor for overheating alarms and ensure the pump is functioning properly.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2434-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2434-2023 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.
