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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiosave Hybrid

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 Class 2 Device Recall Cardiosave Hybridsee related information
Date Initiated by FirmFebruary 28, 2023
Date PostedMarch 22, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1276-2023
Recall Event ID 91652
510(K)NumberK112372 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductCardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
Code Information Model Number: 0998-00-0800-31, UDI-DI: 10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number: 0998-00-0800-45, UDI-DI: 10607567108421; Model Number: 0998-00-0800-52, UDI-DI: 10607567108438; Model Number: 0998-00-0800-53, UDI-DI: 10607567108391; Model Number: 0998-00-0800-55, UDI-DI: 10607567108414; Model Number: 0998-00-0800-65, UDI-DI: 10607567113432; Serial Numbers: CB355244F2, CB355245F2, CB356759G2, CB356760G2, CB351303D2 CB355431F2 CB355432F2 CB355433F2 CB355434F2 CB355435F2 CB356761G2 CB356762G2 CB356763G2 CB356764G2 CB356765G2 CB351313D2 CB352952E2 CB352953E2 CB355240F2 CB355241F2 CB355242F2 CB355243F2 CB356766G2 CB356767G2 CB356768G2 CB356769G2 CB356770G2 CH351787D2 CH352224D2 CH352225D2 CH352228D2 CH352280E2 CH352283E2 CH352284E2 CH352287E2 CH352289E2 CH352290E2 CH352297E2 CH352298E2 CH353439E2 CH353443E2 CH353445E2 CH353448E2 CH353451E2 CH353454E2 CH353795F2 CH353796F2 CH353797F2 CH353798F2 CH353799F2 CH353801F2 CH353802F2 CH353803F2 CH353804F2 CH353805F2 CH353806F2 CH353807F2 CH353808F2 CH353809F2 CH353810F2 CH353811F2 CH353812F2 CH353813F2 CH353814F2 CH354143F2 CH354144F2 CH354145F2 CH354146F2 CH354147F2 CH354148F2 CH354149F2 CH354150F2 CH354151F2 CH354152F2 CH354153F2 CH354154F2 CH354155F2 CH354156F2 CH354157F2 CH354158F2 CH354159F2 CH354160F2 CH354161F2 CH354162F2 CB351043D2 CB351792D2 CB352956E2 CB353456E2 CB354411F2 CB354412F2 CB354413F2 CB354414F2 CB354415F2 CB354416F2 CB354417F2 CB354418F2 CB354419F2 CB355239F2 CB356772G2 CB356773G2 CB356774G2 CB356775G2 CB356776G2 CA209023D2 CH257564F7 CH352970E2 CH355589F2 CA211084E2 CH257750F7 CH352973E2 CH355590F2 CA212105F2 CH260122H7 CH352975E2 CH355591F2 CA212724F2 CH260980H7 CH352976E2 CH355592F2 CA213851G2 CH261704H7 CH352979E2 CH355593F2 CA214935H2 CH263200I7 CH352981E2 CH355594F2 CA216307I2 CH263202I7 CH352983E2 CH355595F2 CA217776J2 CH263207I7 CH352986E2 CH355596F2 CA217786J2 CH263209I7 CH353368E2 CH355597F2 CA226551D3 CH263211I7 CH353370E2 CH355708G2 CA226957D3 CH265706J7 CH353371E2 CH355709G2 CA227974E3 CH266125J7 CH353372E2 CH355710G2 CA227979E3 CH266143J7 CH353373E2 CH355711G2 CA229121E3 CH266878K7 CH353374E2 CH355712G2 CA237955K3 CH269587L7 CH353376E2 CH355713G2 CA245024D4 CH270087L7 CH353378E2 CH355714G2 CA246297E4 CH270088L7 CH353381E2 CH355715G2 CA247925F4 CH271216A8 CH353383E2 CH355716G2 CA249755G4 CH274609C8 CH353385E2 CH355717G2 CA251232H4 CH276227D8 CH353386E2 CH355718G2 CA251252H4 CH276230D8 CH354420F2 CH355719G2 CA251720I4 CH277366D8 CH354421F2 CH355720G2 CH203093L4 CH277844E8 CH354422F2 CH355721G2 CH203613L4 CH279405E8 CH354423F2 CH355722G2 CH203794L4 CH280574F8 CH354424F2 CH355723G2 CH203795L4 CH284286H8 CH354425F2 CH355724G2 CH208131C5 CH284289H8 CH354426F2 CH355725G2 CH210973E5 CH284293H8 CH354427F2 CH355726G2 CH210974E5 CH285038H8 CH354428F2 CH355727G2 CH212821F5 CH286421I8 CH354429F2 CH356090G2 CH214976G5 CH286990I8 CH354430F2 CH356091G2 CH215363G5 CH289804J8 CH354431F2 CH356092G2 CH216809H5 CH289805J8 CH354432F2 CH356093G2 CH216816H5 CH289806J8 CH354433F2 CH356094G2 CH220795J5 CH291673K8 CH354434F2 CH356095G2 CH222872K5 CH293251L8 CH354435F2 CH356096G2 CH222888K5 CH293258L8 CH354436F2 CH356097G2 CH222889K5 CH296588B9 CH354437F2 CH356098G2 CH222891K5 CH299569C9 CH354438F2 CH356099G2 CH222897K5 CH299573C9 CH354439F2 CH356100G2 CH222898K5 CH303093E9 CH354724F2 CH356101G2 CH223512K5 CH307520G9 CH354725F2 CH356102G2 CH223540K5 CH308230H9 CH354726F2 CH356103G2 CH232203D6 CH311931I9 CH354727F2 CH356104G2 CH232213D6 CH312530J9 CH354728F2 CH356105G2 CH233414E6 CH314067J9 CH354729F2 CH356106G2 CH233420E6 CH314077J9 CH354730F2 CH356107G2 CH235254F6 CH314282J9 CH354731F2 CH356108G2 CH235259F6 CH314284J9 CH354732F2 CH356109G2 CH236295F6 CH314289J9 CH354733F2 CH356246G2 CH236307F6 CH315552K9 CH354734F2 CH356247G2 CH246500L6 CH315555K9 CH354735F2 CH356248G2 CH247705L6 CH316289L9 CH354736F2 CH356249G2 CH250188B7 CH330263K0 CH354737F2 CH356250G2 CH250993B7 CH330725L0 CH354738F2 CH356251G2 CH251004B7 CH331534L0 CH354739F2 CH356252G2 CH252916C7 CH335172D1 CH354740F2 CH356253G2 CH256993E7 CH338672F1 CH354741F2 CH356254G2 CH257551F7 CH341944I1 CH354742F2 CH356255G2 CH257558F7 CH345853L1 CH354743F2 CH358824I2 CH257561F7 CH351793D2 CH355588F2 CA222643A3 CB293277L8 CB351786D2 CB352696E2 CB352698E2 CB352701E2 CB352702E2 CB352703E2 CB352958E2 CB355439F2 CB355440F2 CB355441F2 CB355442F2 CB355443F2 CB352222D2 CB352223D2 CB353458E2 CB353460E2 CB353462E2 CB353464E2 CB353568F2 CB353569F2 CB353572F2 CB353573F2 CB353574F2 CB353575F2 CB353577F2 CB353578F2 CB353579F2 CB353580F2 CB353581F2 CB353582F2 CB356771G2 CH250188B7 CH330725L0 CH354741F2 CH360749K2 CH250993B7 CH331534L0 CH354742F2 CH251004B7 CH335172D1 CH354743F2
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information ContactMarylou Insinga
973-709-7442
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
ActionAn 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 Commerce391 total IABPs
DistributionDistribution list not yet provided.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DSP
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