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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 hybrid see related information
Date Initiated by Firm April 04, 2023
Date Posted April 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-1462-2023
Recall Event ID 92021
510(K)Number K112372  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Code Information UDI-DI: 10607567111117; Serial Numbers: CB343612K1 CB351306D2 CB360094J2 CB351302D2 CB343613K1 CB359782J2 CB359780J2 CB320625E0 CH207880C5 CB359783J2 CB328500J0 CB356765G2 CB356763G2 CB314092J9 CB355433F2 CB355432F2 CB351305D2 CB311676I9 CB355435F2 CB319727D0 CB319726D0 CB342653J1 CB307113G9 CB360092J2 CH245699K6 CB307117G9 CB360095J2 CB351303D2 CB320623E0 CB320621E0 CB320620E0 CB311677I9 CB314093J9 CB356761G2 CB351307D2 CB329943K0 CB360093J2 CB307111G9 CB343611K1 CB307114G9 CB320624E0 CB351301D2 CB359781J2 CB351304D2 CB356762G2 CB355434F2 CB322068F0 CB342652J1 CB311675I9 CB320622E0 CB355431F2 CB314094J9 CB307112G9 CB307119G9
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Stephanie Moretti
973-709-7170
Manufacturer Reason
for Recall		 The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
FDA Determined
Cause 2		 Component design/selection
Action An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION was sent to customers beginning 4/4/23. Actions to be taken by the Customer now: Our records indicate that that you have received one or more CARDIOSAVE hybrid IABPs having the serial numbers that are affected by this recall. 1. Inspect the IABP to determine if it has a Type J power plug (refer to Image 1 below). If present, the IABP should not be used until the cord reel has been replaced. 2. Schedule a service appointment with your Datascope Corp./Getinge Service Representative for the cord reel correction from a Type J connector to Type N (refer to Image 2 below). 3. Please ensure that all Cardiosave Intra-Aortic Balloon Pump users at your hospital / facility are aware of this notice. 4. Please forward this information to all current and potential Cardiosave Hybrid IABP users within your hospital/facility. 5. If you are a distributor who has shipped any affected products to customers, please forward this letter to their attention for appropriate action. Actions to be taken: Please examine your inventory to determine you have a Cardiosave Hybrid IABP. Whether you have an affected cord or not, please complete and sign the attached RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Actions to be taken by Getinge: Getinge will update the affected Cardiosave Hybrid IABPs that contain a Type J connector with a Type N connector to correct and address this issue. This voluntary correction notification only affects the products listed on page 1; no other products are affected by this voluntary correction. We apologize for any inconvenience this Medical Device Correction may cause. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope Corp./Getinge Representative or office.
Quantity in Commerce 54 units
Distribution International distribution in the country of Brazil.
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
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