medical MODERATE Updated 2026-03-11

Datascope Corp. recalls CS100 IABP. Software Version CS100 IABP Q.01.

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Recalled Product

CS100 IABP. Software Version CS100 IABP Q.01.

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Hazard / Issue

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Model No; All UDI; All Serial No.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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