Cardiosave IABP Pneumatic Interface Module Recalled for Performance Issue
Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.
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: This recall is classified as High because it involves a critical cardiac-support device where performance degradation could affect patient outcomes. Although no illnesses have been reported and the reduction is described as 'slight,' the device's role in maintaining hemodynamic support during therapy presents a risk-of-harm that warrants this classification.
Plain-English summary
The Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM), Model Number 0997-00-1178, manufactured by Datascope Corp., is being recalled. The recall affects 10 specific units identified by serial number.
The Safety Disk in these units does not meet performance requirements. This defect may impact the Intra-Aortic Balloon catheter's displacement volume, potentially resulting in slightly reduced balloon inflation during therapy or a reduction in the degree of augmentation provided to patients.
Healthcare facilities and clinicians using these devices should verify whether they have any of the affected serial numbers: MH353075E2, MH353057E2, MH353067E2, MH353077E2, MH356112G2, MH353056E2, MH356111G2, MH356119G2, MH353065E2, MH356117G2. If an affected device is identified, contact Datascope Corp. for further instructions.
The recalled product
- Product
- Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
- Manufacturer
- Datascope Corp.
- Affected units
- 10
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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