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Class 2 Device Recall Cardiosave Hybrid |
 |
Date Initiated by Firm |
February 28, 2023 |
Date Posted |
March 22, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1276-2023 |
Recall Event ID |
91652 |
510(K)Number |
K112372
|
Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
|
Product |
Cardiosave 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
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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
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For Additional Information Contact |
Marylou Insinga 973-709-7442
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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.
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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 |
391 total IABPs |
Distribution |
Distribution list not yet provided. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DSP and Original Applicant = CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
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