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MEDICAL DEVICE RECALLMODERATE

Datascope CS300 IABP

Datascope is updating the Instructions for Use for the CS300 IABP (software version C.01) to correct battery runtime and cycle specifications.

What to do

Review the updated Instructions for Use provided by the manufacturer to ensure accurate understanding of battery runtime and cycle specifications.

Recalled
Listed
Updated
Recall No.
Z-1487-2026
Agency
FDA
Firm
Datascope Corp.
Recall ID
98189
Status
ONGOING

Recall at a glance

Quantity recalled
10,897 units

Why it was recalled

Datascope Corp. is updating the Instructions for Use for the CS300 Intra-Aortic Balloon Pump (IABP) to correct battery runtime and cycle specifications. The affected devices operate on software version CS300 IABP C.01.

Is mine affected?

This recall covers the products below. If you have any of them, yours is affected.

ProductRecall #
CS300 IABP. Software Version CS300 IABP C.01.Z-1487-2026
CS100 IABP. Software Version CS100 IABP Q.01.Z-1486-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Datascope Corp.

All recalls from Datascope Corp.

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Editorial summary by Recall Canary · summary updated 2026-07-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification