Cardiosave IABP Safety Disk Model 0202-00-0140 Recalled for Performance Defect
Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.
What this means for you
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: This recall involves a Class II FDA medical device (cardiac support component) with a performance defect that may reduce therapeutic efficacy. The hazard is described as potential rather than confirmed, with impacts characterized as 'slight' reductions in balloon inflation and cardiac augmentation. The high score reflects the critical nature of the product category without documented adverse events.
Plain-English summary
Datascope Corp. is recalling the Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model 0202-00-0140, a critical component of cardiac support systems used in intensive care settings. Approximately 669 safety disks with specific manufacturer serial numbers are affected by this recall.
The Safety Disk does not meet a performance requirement that may impact the intra-aortic balloon catheter displacement volume. This defect may result in slightly reduced balloon inflation during therapy or a reduction in the degree of cardiac augmentation provided to the patient.
Healthcare facilities should verify whether they have devices with the recalled serial numbers in their inventory. Patient management decisions should be coordinated with Datascope Corp. and the patient's healthcare provider.
The recalled product
- Product
- Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
- Manufacturer
- Datascope Corp.
- Hazard
- performance-defect
- reduced-cardiac-augmentation
Distribution
Distribution scope not specified by the agency.
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