The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1941-2019·Announced 2019-07-24

Datascope CS100 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time. Revised labeling and training are being offered.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered."

Plain-English summary

Datascope Corp. is recalling the CS100 Intra-Aortic Balloon Pump, English, 110V (model 0998-00-3013-53), for cardiovascular use. The recall involves 16,656 units distributed worldwide, including the United States and numerous international locations. All serial numbers are affected.

The recall is being conducted because if battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. This could potentially impact the device's ability to function as intended during use.

Datascope Corp. is offering revised labeling and training to address the issue. Users of the device should contact the recalling firm for details on the revised labeling and training resources.

The recalled product

Product
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 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 →

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