CS100 IABP Medical Device Battery Specifications Documentation Update
Datascope Corp. is updating battery runtime and cycle specifications in the technical documentation for the CS100 IABP cardiac support device distributed worldwide.
What this means for you
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: FDA Class II recall addressing a documentation issue in the device's Instructions for Use. The source does not report any illnesses, injuries, or incidents. The classification reflects that this is a precautionary documentation correction with no evidence of actual harm.
Plain-English summary
The CS100 IABP (Intra-Aortic Balloon Pump), Software Version Q.01, manufactured by Datascope Corp., is the subject of a Class II recall. The manufacturer has identified that the battery runtime and cycle specifications contained in the device's Instructions for Use (IFU) need to be updated.
The device is distributed worldwide, including throughout the United States and over 80 additional countries. Approximately 10,897 units are affected, encompassing all model numbers, UDI codes, and serial numbers of this software version.
The manufacturer is correcting the device's technical documentation to ensure accurate battery runtime and cycle specifications.
The recalled product
- Product
- CS100 IABP. Software Version CS100 IABP Q.01.
- Manufacturer
- Datascope Corp.
- Hazard
- inaccurate-specifications
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.
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