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 is a medical device used to assist patients with cardiac issues during critical care. Hospitals typically purchase this device for use in emergency and surgical settings.
The hazard arises from a potential lack of proper maintenance, which could lead to device failure during critical procedures, affecting patient safety.
This recall is not part of a broader industry pattern.
The recall necessitates immediate action from healthcare providers to ensure patient safety, potentially leading to disruptions in medical procedures.
The model number and serial number are typically found on the back or bottom of the device.
Expect a timeline of 4-6 weeks for refund processing after contacting the manufacturer.
Keep photographs of the device, records of any maintenance performed, and all correspondence regarding the recall.
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.
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Datascope recalled 11,470 Intra-Aortic Balloon Pump systems on November 4, 2025. The recall addresses a revision in the Preventative Maintenance schedule as outlined in the Service Manual. Healthcare providers and patients must stop using these devices immediately.