Cardiosave Hybrid IABP Recall: Incorrect Compliance Annotation in Instructions
The Cardiosave Hybrid Intra-Aortic Balloon Pump software update version D.00 includes instructions with incorrect annotations about compliance to standard 60601-1-12:2014. Four units were distributed in Germany.
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: This recall involves a Class III medical device with a labeling error in the instructions for use. No illnesses or injuries have been reported. The error is a minor labeling issue involving incorrect compliance annotations, and the hazard is purely informational rather than a product defect.
Plain-English summary
Datascope Corp. is recalling the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), model 0998-00-0800-55, due to a documentation error. The digital instructions provided with the software update to version D.00 contain incorrect annotations regarding the device's compliance to standard 60601-1-12:2014.
The issue affects the regulatory compliance information presented in the device's instructions for use (IFU). Four units were distributed in Germany, with serial numbers CB286971I8, CB283804G8, CB283867G8, and CB283522G8.
Healthcare facilities should verify the accuracy of their device's compliance information against corrected instructions as they become available from the manufacturer.
The recalled product
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
- Manufacturer
- Datascope Corp.
- Hazard
- labeling-error
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 (2)
- UDI-DI: 10607567108414
- Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8
Distribution
Distribution scope not specified by the agency.
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