Z-0897-2022Class II

Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide...

Name: Z-0897-2022 Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide...
Creator: Maquet Medical Systems USA
Published: 2022-02-18
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2022-02-18 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Medical Systems USA began a recall of Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the... on 2022-02-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0897-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-18
Posted: 2022-04-08
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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)
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: 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 tag: manufacturing process
FDA 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 [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
Quantity in commerce: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0897-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0897-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-08

Product code DTQ

K133598Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2014-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)