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MAQUET CARDIOHELP recallZ-0897-2022 · Maquet Medical Systems USA · initiated Feb 18, 2022

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

Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.

FDA root cause category: Process control

What the company is doing

Getinge issued Urgent Medical Device Correction Letter dated 2/18/22 via FedEx 2 day service with signature required. . Letter states reason for recall, health risk and action to take: A general decommissioning of the affected Cardiohelp-i is not required, with the consideration of the following: 1. Please examine your inventory immediately to determine if you have received any Cardiohelp-i products with one of the affected serial numbers. 2. If you have a Cardiohelp-i affected by this field correction, please examine your inventory immediately to locate all Transport Guards used with Cardiohelp-i products. Please ensure that the Transport Guard can be opened and that the cylindrical pin is not loose prior to using the device. If so, the device can continue to be used. If your Transport guard cannot be opened or if the cylindrical pin is loose, please remove from use and place in a quarantine location to avoid future use. This activity should be performed prior to every use until the field correction activities have been completed at your facility by a Getinge Representative. 3. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5). A Getinge Service Technician will contact the person you list on the Customer Response Form to schedule service for an inspection of your device. Return the completed form to Maquet Cardiopulmonary GmbH /Getinge by emailing a scanned copy to [email protected] or by faxing the form to 1(888) 722-5375. If your Transport Guard displays the issue identified in this notification, it will be replaced at no cost to your facility. 4. Whether or not you have affected product(s) with the serial numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification, per the instruction in number 3 above. 5. You can also arrange a visit by a Getinge trained or au

Recall details

Recall number
Z-0897-2022
Status
Open, Classified
Initiated by the company
Feb 18, 2022
Recalling firm
Maquet Medical Systems USA
Quantity
US: 32 units; OUS 30 units
Product code
DTQ
FDA submissions
K133598
Distribution
US Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA Foreign: Belgium, Canada, Germany, Hungary, Luxemburg, Malaysia, Mexico, Poland, Slovakia, South Africa, South Korea, and Taiwan.

Product description

Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product Code/REF Number: 701072780 (Cardiohelp-i)

Code information (models, lots, serial numbers)

Serial Numbers for the Cardiohelp-i (Part Number 701072780)as the Transport Guard (701072525) is packaged with the Cardiohelp-i and is not labelled individually  Serial Numbers: 90413945, 90414225, 90414226, 90414227, 90414228, 90414229, 90414232, 90414233, 90414234, 90414235, 90414236, 90414237, 90414283, 90414284, 90414285, 90414286, 90414287, 90414288, 90414289, 90414292, 90414293, 90414294, 90414295, 90414296, 90414297, 90414309, 90414310, 90414311, 90414312, 90414317, 90414318, 90414319.  UDI: 04058863074863 (Cardiohelp-i)

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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