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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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
The recall cites the need to update battery runtime and cycle specifications in the Instructions for Use. The issue could affect how the device operates over time if未 updated guidelines are relied upon.
1. Stop using the product. 2. Follow the recall instructions provided by the manufacturer. 3. Contact Datascope Corp. or your healthcare provider for guidance. 4. Await further instructions communicated by letter.
Manufacturer: Datascope Corp. Recall notifications issued by Datascope. Website/phone: Not specified in the notice. FDA page linked for reference: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1486-2026
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