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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiohelpi

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  Class 2 Device Recall Cardiohelpi see related information
Date Initiated by Firm October 12, 2023
Date Posted November 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-0290-2024
Recall Event ID 93013
510(K)Number K133598  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Code Information UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868
Recalling Firm/
Maquet Medical Systems USA
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Ms. Marylou Insinga
Manufacturer Reason
for Recall
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.
FDA Determined
Cause 2
Device Design
Action An URGENT MEDICAL DEVICE Correction notification letter dated 10/12/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received a CARDIOHELP-i System having a serial number that is affected by this voluntary Medical Device Correction. " Please examine your inventory immediately to determine if you have any affected CARDIOHELP System(s) in your inventory. " Should you have any affected CARDIOHELP-i System(s), your unit(s) will need to be returned to Getinge for correction. Getinge will contact your facility to arrange the return of your unit for correction. A CARDIOHELP loaner can be provided if needed. " Please do not to fixate any accessory at the slide rail until the slide rail holders have been replaced. " Affected CARDIOHELP-i can be used for intra-hospital transport only when placed on a Sprinter cart. " Inter-hospital transport is not permitted until the slide rail holders have been replaced. " Please forward this information to all current and potential CARDIOHELP-i users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. " Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE- CORRECTION RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to Cardiohelpsliderail2023.act@getinge.com or by faxing the form to 1-866-313-4049. Type of Action by Getinge: A Getinge representative will contact you to arrange for the repair of your CARDIOHELP -i unit(s). Getinge will correct your CARDIOHELP -i unit(s) upon receipt and will return your unit(s) once correction has been completed. This voluntary correction only affects the products listed on Page 1; no other products are affected by this voluntary correction. We apologize for
Quantity in Commerce 1022 units
Distribution US Nationwide.
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 = DTQ and Original Applicant = MAQUET CARDIOPULMONARY AG