The Recall Desk
SevereFDA (Devices)·Z-1943-2019·Announced 2019-07-24

Datascope CS300 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

Datascope Corp. is recalling CS300 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies this as a Class I recall, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Datascope Corp. is recalling the CS300 Intra-Aortic Balloon Pump, English, 110V (model 0998-00-3023-53). The recall involves 16,656 units distributed worldwide, including the United States and numerous international locations. All serial numbers are affected.

The recall is issued because if battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power. This is a Class I recall classified by the U.S. Food and Drug Administration.

Healthcare facilities and users should contact Datascope Corp. for further instructions regarding the recall and proper battery maintenance procedures.

The recalled product

Product
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiovascular
Hazard
Affected units
16,656

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers affected

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Datascope Corp.

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Same hazard · battery failure

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