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Recall Observatory FDA recall evidence

Device product

Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178

Z-1279-2023

February 28, 2023

Class II

Product summary

Firm
Datascope Corp.
Event
Event 91652
Status
Ongoing
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-1279-2023

Official wording

Reason: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.

Code information: Serial Numbers: MH353075E2 MH353057E2 MH353067E2 MH353077E2 MH356112G2 MH353056E2 MH356111G2 MH356119G2 MH353065E2 MH356117G2

Distribution pattern: Distribution list not yet provided.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.