Intra-Aortic Balloon Catheters Recalled for Packaging Label Discrepancy
Datascope Corp. is recalling 160 units of MEGA 7.5Fr intra-aortic balloon catheters due to discrepant labeling between inner and outer packaging, which could cause confusion about proper use.
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 labeling discrepancy with no reported illnesses or injuries. While labeling accuracy matters for medical device safety, the issue is administrative rather than functional, with no documented harm.
Plain-English summary
Datascope Corp. is recalling 160 units of MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories (Model 0684-00-0295-01, Lot 3000344298). This is a cardiac medical device used to provide mechanical circulatory support during cardiac interventions.
The recalled devices have discrepant labeling on the inner and outer packaging. Inconsistencies between packaging labels could cause confusion regarding device specifications, storage instructions, handling requirements, or use procedures.
The devices were distributed internationally to Germany, Spain, Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, and Singapore.
Healthcare providers and facilities with these devices should verify packaging labeling and address any discrepancies before clinical use. Contact Datascope Corp. for corrected labeling information or device replacement.
The recalled product
- Product
- MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
- Manufacturer
- Datascope Corp.
- Hazard
- labeling-discrepancy
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: 10607567107974
- Lot Number: 3000344298
Distribution
Distribution scope not specified by the agency.
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