Datascope recalled 47 units of its Cardiosave Rescue Intra-Aortic Balloon Pump on November 4, 2025. The recall addresses a revised Preventative Maintenance schedule in the device's instructions for use. This issue poses a high risk to patient safety and requires immediate attention from healthcare providers.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Datascope Corp. or your healthcare provider for instructions. Notification method: Letter
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The Cardiosave Rescue Intra-Aortic Balloon Pump, model number 0998-00-0800-83, is designed for use in critical care settings. It was distributed across multiple countries, including the United States and many international regions. The recall affects 47 units.
The revision in the Preventative Maintenance schedule could lead to improper device functioning. If not maintained correctly, the device may fail during critical medical procedures, posing a serious risk to patients.
No specific incidents of injury or death have been reported as a result of this issue. However, the potential for harm exists if the device is not properly maintained.
Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's instructions and contact Datascope Corp. for further guidance.
For assistance, reach Datascope Corp. at [insert contact number] or visit their website for more details.
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