CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report

Cardiohelp-i Transport Guard with Transport Guard recalled

Maquet Medical Systems USA is recalling Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and, distributed nationwide in the US. The recall was initiated on 18 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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)

Quantity recalledUS: 32 units; OUS 30 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0897-2022
FDA event ID: 89745
Recalling firm: Maquet Medical Systems USA, Wayne, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 18 Feb 2022
FDA classified: 8 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Feb 2022	Recall initiated by company
8 Apr 2022	Classified by FDA	+49 days
13 Apr 2022	Published in enforcement report	+5 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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)

Where it was distributed

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.

Nationwide Florida Kentucky New Hampshire New Jersey New York Pennsylvania Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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)

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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