Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk Recalled by Datascope Corp. Due to There is an issue related to the Safety...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Datascope Corp. directly.
Affected Products
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Quantity: 669 safety disks
Why Was This Recalled?
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.
Where Was This Sold?
Distribution list not yet provided.
About Datascope Corp.
Datascope Corp. has 66 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report