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 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.
The recall stems from an update to the Preventative Maintenance schedule that may impact device performance. The FDA classified this recall as Class II, indicating a moderate risk to patient safety.
No specific incidents or injuries have been reported related to this recall. The potential risks associated with improper maintenance could lead to device malfunction.
Patients and healthcare providers must stop using the recalled devices immediately. They should follow the recall instructions provided by Datascope Corp. For assistance, contact your healthcare provider or Datascope Corp.
For more information, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0916-2026.
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