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MAQUET CARDIOHELP recallZ-0290-2024 · Maquet Medical Systems USA · initiated Oct 12, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Medical Systems USA or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-0290-2024
Status
Open, Classified
Initiated by the company
Oct 12, 2023
Posted by the FDA
Nov 9, 2023
Recalling firm
Maquet Medical Systems USA
Quantity
1022 units
Product code
DTQ
FDA submissions
K133598
Distribution
US Nationwide.

Product description

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)

Code information (models, lots, serial numbers)

UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K133598 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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