Maquet Medical Systems USA: 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)

Recall number

Z-0897-2022

Recalling firm

Maquet Medical Systems USA

Product

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)

Status

Open, Classified

Initiated

2022-02-18

Posted

not on file

Terminated

not on file

Reason

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.

Root cause

Process control

Action

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 Transportguardpin2022.act@getinge.com 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

Quantity

US: 32 units; OUS 30 units

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.

Lot, serial or model codes

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)

510(k) numbers

["K133598"]

PMA numbers

not on file

Product code

DTQ

Firm FEI

3008355164

Firm city

Wayne

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy