The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1942-2019·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 the minimum run time of operating power.

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 source text explicitly identifies this as a Class I recall. Per the rubric, FDA Class I recalls are classified as Severe (score 4) or Critical (score 5). Since no reported deaths are mentioned in the source text, the score is 4.

Plain-English summary

Datascope Corp. is recalling the CS100 Intra-Aortic Balloon Pump, English, 220V (catalog number 0998-00-3013-55). The recall involves 16,656 units that were 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 is a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Revised labeling and training are being provided to address the issue. Users of the device should contact Datascope Corp. for further instructions regarding the recall and the provision of updated materials.

The recalled product

Product
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 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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