Datascope recalled 10,897 CS100 IABP devices worldwide on Jan. 23, 2026. The issue concerns battery runtime and cycle specifications in the device Instructions for Use. Healthcare providers and patients must stop using the device and follow recall instructions.
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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CS100 IABP is a hospital-use cardiology device used to support the heart by inflating a sleeve in the aorta during cardiac procedures.
The hazard stems from outdated battery runtime and cycle specifications in the Instructions for Use, which could affect device performance.
This recall is not part of a broader industry pattern.
Hospitals and patients must stop using the device until updated IFU guidance is applied. No injuries are reported, but the risk is potential misoperation if specifications are not updated.
Recall details are posted on the FDA enforcement page and should be in manufacturer communications. The URL provided in the notice is the primary reference.
The recall process timeline for updates and guidance is not specified.
Keep a copy of the recall notice, track device identifiers, document communications with the manufacturer, and preserve any failure reports.
Model numbers: All Model No. All UDI. All Serial No. Where sold: Worldwide distribution, including US nationwide and the listed countries. When sold: Unknown Price: Unknown
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