Cardiosave Hybrid Intra-Aortic Balloon Pump Power Cord Incompatible with Brazilian Outlet
Datascope Corp. is recalling 54 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump distributed to Brazil. The Type J power cord plug is incompatible with Brazilian Type N electrical receptacles.
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: This is a Class II recall with no reported illnesses or injuries. The power cord incompatibility prevents normal device operation but does not describe an inherent safety hazard. This qualifies as a moderate, precautionary recall to address the functional incompatibility.
Plain-English summary
Datascope Corp. is recalling 54 units of the MAQUET Cardiosave Hybrid Intra-Aortic Balloon Pump (Model 0998-XX-0800-32) distributed to Brazil. The power cord supplied with the device features a Type J plug end that is incompatible with the Brazilian Type N electrical receptacle.
Because the supplied power cord does not fit Brazilian electrical outlets, the device cannot be powered using the included cord. The affected units are identified by specific serial numbers and the unique device identifier (UDI-DI: 10607567111117) provided by the manufacturer.
The recalled product
- Product
- MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
- Manufacturer
- Datascope Corp.
- Category
- Medical Device
- Affected units
- 54
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)
- UDI-DI: 10607567111117
Distribution
Distribution scope not specified by the agency.
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