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U.S. Department of Health and Human Services

Class 2 Device Recall Safety Disk

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  Class 2 Device Recall Safety Disk see related information
Date Initiated by Firm February 28, 2023
Date Posted March 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-1279-2023
Recall Event ID 91652
510(K)Number K112372  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Code Information Serial Numbers: MH353075E2 MH353057E2 MH353067E2 MH353077E2 MH356112G2 MH353056E2 MH356111G2 MH356119G2 MH353065E2 MH356117G2
Recalling Firm/
Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Marylou Insinga
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Under Investigation by firm
Action An URGENT MEDICAL DEVICE CORRECTION dated 2/28/23 was sent to customers. User Actions to be taken: A review of our records indicate that you may have a Cardiosave IABP at your facility with an affected Safety Disk or affected spare Safety Disks or PIM assembly installed recently into Cardiosave IABP. 1. Please examine your inventory immediately to determine if you have any Cardiosave IABPs with the affected Safety Disks and/or PIM, or any affected Safety Disk and/or PIM assembly spare parts, per attachment 1. 2. You may continue to use any affected IABPs until replacement parts are installed. Please keep in mind the potential health risks cited above, particularly with prolonged heart rates above 100 beats per minute for three consecutive hours. When transporting patients outside the hospital environment, consider using an unaffected console if available. 3. Should you have any unused affected spare parts of the Safety Disk or PIM Assembly in your inventory, please remove them from areas of use and contact your local Datascope/Getinge Customer Service department at 888-9GETUSA (888 943-8872) to request a return authorization (RMA) and shipping instruction to return the affected product for credit. 4. If you installed an affected spare part into one of your IABPs the Safety Disk will need to be replaced. 5. If you purchased spare parts and they are no longer in your inventory and you are unsure of their location, please contact Getinge Service. Getinge Service will schedule an on-site visit to inspect your IABP/(s) at no cost to your facility. 6. Should you have any affected Cardiosave IABPs you will be contacted by a Getinge Service Representative to schedule an on-site visit to replace the Safety Disk, free of charge. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone
Quantity in Commerce 10
Distribution Distribution list not yet provided.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC