Datascope Corp. recalls 10,897 CS300 IABP devices sold through healthcare providers worldwide after determining the battery runtime and cycle specifications in the Instructions for Use must be updated. The issue is an information update rather than a device fault. Stop using the device immediately and follow the manufacturer’s recall instructions. Contact Datascope Corp. or your healthcare team to
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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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CS300 IABP is a specialized cardiac support device used in clinical settings to assist heart function. It is typically managed by healthcare facilities and clinicians.
The recall addresses updates needed to battery runtime and cycle specifications in the IFU, which could impact device operation guidance.
This recall is not described as part of a broader industry pattern.
The immediate action required is to halt use of affected devices and await manufacturer guidance, which may affect procurement and clinical workflows.
Recall number Z-1487-2026 on the FDA enforcement page and manufacturer communications.
Refunds or replacements are typically processed after manufacturer remediation steps, but no firm timeline is provided in the recall notice (investor/
Keep recall notices, correspondence, inventory lists of affected devices, and any disposal or quarantine actions.
Model numbers: CS300 IABP CS300 IABP C.01. Sold worldwide through healthcare providers. Sold date and price not specified.
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