Cardiosave Hybrid Intra-Aortic Balloon Pump Performance Issue Recall
Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a high-risk cardiac support device with a theoretical performance-related hazard and no reported injuries, meeting the rubric criterion for 'High' severity where injury has not yet been reported.
Plain-English summary
Datascope Corp. is recalling the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. A total of 391 units have been affected.
The Safety Disk in these devices may not meet required performance specifications. This could impact the displacement volume of the intra-aortic balloon catheter.
The potential failure may result in slightly reduced balloon inflation during therapy or a reduction in the degree of augmentation provided to the patient during treatment. No injuries or illnesses have been reported in connection with this issue.
The recalled product
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Manufacturer
- Datascope Corp.
- Affected units
- 391
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 (7)
- Model Number: 0998-00-0800-75
- UDI-DI: 10607567112312
- Model Number: 0998-00-0800-83
- UDI-DI: 10607567108407
- Model Number: 0998-00-0800-85
- UDI-DI: 10607567113449
- Serial Numbers: CA237026J3 CH231276C6
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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