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 the minimum required 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 agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Datascope Corp. is recalling the CS300 Intra-Aortic Balloon Pump, English, 220V (model 0998-00-3023-55), for cardiovascular use. The recall involves 16,656 units distributed worldwide, including the United States and numerous international locations.
The recall is being issued because if battery maintenance is not performed according to the manufacturer's instructions, the battery may provide less than the minimum run time of operating power. All serial numbers are affected.
The U.S. Food and Drug Administration has classified this as a Class I recall. Consumers and healthcare providers should contact Datascope Corp. for further instructions regarding the recall and proper battery maintenance.
The recalled product
- Product
- CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 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
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.
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