Datascope CS300 balloon pump manual recalled for outdated battery specifications
Datascope is recalling the CS300 IABP running software version C.01 because the battery runtime and cycle specifications in the device's Instructions for Use need to be updated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers minor labelling errors: the recall corrects specifications printed in the Instructions for Use, and the source describes no defect or malfunction in the device.
Plain-English summary
Datascope Corp. is recalling the CS300 IABP, software version CS300 IABP C.01. About 10,897 units were distributed worldwide, covering the United States nationwide and more than eighty other countries. The FDA has classified this recall as Class II.
The firm has identified that the battery runtime and cycle specifications contained in the device's Instructions for Use need to be updated. The source record does not describe a defect or malfunction in the device itself.
All model numbers, UDIs and serial numbers are affected.
Facilities can identify affected devices by the software version above, and may contact Datascope Corp. for further information.
The recalled product
- Product
- CS300 IABP. Software Version CS300 IABP C.01.
- Manufacturer
- Datascope Corp.
- Affected units
- 10,897
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 (3)
- All Model No
- All UDI
- All Serial No.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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