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.
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 Intra-Aortic Balloon Pump is a medical device used to assist patients with severe cardiac conditions. It is employed during procedures to help improve blood flow and decrease the workload on the heart.
The recall addresses an important update to the Preventative Maintenance schedule, which is essential for ensuring the device functions properly and safely. Failure to adhere to the updated maintenance guidelines could lead to device malfunction.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act immediately to avoid potential risks associated with using the affected devices. The recall may cause disruptions in patient care but is necessary for ensuring safety.
Model numbers can typically be found on the device label or in the user manual.
Expect a refund or replacement process to take approximately 4-6 weeks once initiated.
Keep copies of all correspondence, receipts, and documentation related to the recall for your records.
The recalled models include D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, and D998-UC-0800-55. The devices were distributed both domestically and internationally.
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