Use caution Medical device recall · FDA · Published February 18, 2022

Maquet Cardiohelp-i Transport Guard Recall: Loose Pin May Cause Jamming

Maquet recalls Cardiohelp-i Transport Guard (serials 90413945-90414319) due to potential loose pin causing jamming or disassembly, delaying critical medical support.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0897-2022Medical device Maquet Medical Systems ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMaquet Medical Systems USA45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

Maquet is recalling specific Cardiohelp-i Transport Guards that may have a loose pin causing the device to jam or disassemble. This could delay critical medical support during emergencies if a product exchange is needed. Read more at govinfonow.com/recall/61134-maquet-cardiohelp-i-transport-guard-recall-loose-pin-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/61134-maquet-cardiohelp-i-transport-guard-recall-loose-pin-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0897-2022

Cite this page

“Maquet Cardiohelp-i Transport Guard Recall: Loose Pin May Cause Jamming.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61134-maquet-cardiohelp-i-transport-guard-recall-loose-pin-may-cause. Based on FDA recall #Z-0897-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0897-2022%22&limit=1).

The FDA announced on Feb. 18, 2022, that Maquet Medical Systems USA is recalling the Cardiohelp-i Transport Guard (701072525) due to a potential loose pin that could cause the locking mechanism to jam or the unit to fully disassemble. The agency classified the recall as Class II.

How to tell if you have it

Brand: Maquet Medical Systems
Product: Cardiohelp-i Transport Guard with Transport Guard (701072525)
Product Code/REF Number: 701072780 (Cardiohelp-i)
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)
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

The hazard

According to the FDA, a loose cylindrical pin on the Transport Guard may result in the jamming of the locking mechanism, causing the guard to not open. 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.

Context

GovInfoNow's records show Maquet Medical Systems USA has 14 other recalls on record since July 14, 2021. Recent brand recalls include the April 15, 2024, Cardiohelp-i System Recall for excessive patient leakage current risk and the Jan. 16, 2024, BEQ-HLS 7050 Recall for compromised sterile barrier risk. Other recent recalls of similar products include the Dec. 4, 2025, Merit Medical Allwell Angioplasty Pack Recall and the Feb. 27, 2026, Medline Medical Kits Recall.

How to tell if you have this one

The Cardiohelp-i Transport Guard (model 701072525) with serial numbers starting with 90413945 through 90414319. This device is used with Cardiohelp-i blood oxygenation systems for cardiac surgery.

Brand
Maquet Medical Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Look for the serial number on the device packaging or label, which should start with 90413945 through 90414319.
Contact Manufacturer
If you have the recalled device, contact Maquet Medical Systems USA for instructions on potential fixes or exchanges.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 8 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Kentucky, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Virginia.

Recall timeline

FDA published this recall 54 days after the firm started it.

Feb 18, 2022Firm started the recall
Apr 8, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Maquet Medical Systems recalls

Link to this recall

<a href="https://govinfonow.com/recall/61134-maquet-cardiohelp-i-transport-guard-recall-loose-pin-may-cause">Maquet Cardiohelp-i Transport Guard Recall: Loose Pin May Cause Jamming (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0897-2022 (February 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0897-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.