Use caution Medical device recall · FDA · Published October 12, 2023

Maquet Cardiohelp-i Blood Oxygen System Recall: Nut Bolt Breakage Risk

Maquet recalls Cardiohelp-i blood oxygenation systems with part numbers 701072780 and 701068550 due to risk of nut bolt breaking off during use, potentially causing injury.

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

🇺🇸 FDA recall #Z-0290-2024Medical device Maquet ›

Use caution until it’s fixed

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Maquet is recalling Cardiohelp-i blood oxygenation systems that could have a nut bolt breaking off with slight force, which might cause injury. This recall affects specific model numbers and serial ranges. Read more at govinfonow.com/recall/57076-maquet-cardiohelp-i-blood-oxygen-system-recall-nut-bolt-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/57076-maquet-cardiohelp-i-blood-oxygen-system-recall-nut-bolt-breakage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0290-2024

Cite this page

“Maquet Cardiohelp-i Blood Oxygen System Recall: Nut Bolt Breakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57076-maquet-cardiohelp-i-blood-oxygen-system-recall-nut-bolt-breakage. Based on FDA recall #Z-0290-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2024%22&limit=1).

The FDA announced on Oct. 12, 2023, that Maquet Medical Systems USA is recalling Cardiohelp-i blood oxygenation systems due to a defective weld that allows a nut bolt to break off. The recall affects 1,022 units distributed nationwide.

How to tell if you have it

Brand: Maquet
Product: Cardiohelp-i, blood oxygenation and carbon dioxide removal system
Part Numbers: 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
UDI-DI: 04058863074863
Serial Numbers: 90414355 through 90414868

The hazard

The FDA said the fixation weld employed by the supplier of the nut bolt to the slide rail plate was insufficient. This deficiency allows the nut bolt to break off from the slide rail plate with slight manual force.

Context

GovInfoNow's records show Maquet Medical Systems USA has 14 other recalls on record since July 14, 2021. Other recent recalls of similar products include the Maquet Cardiohelp-i System Recall (April 15, 2024) and the Maquet HLS Set Advanced 5.0 Recall (Jan. 16, 2024).

How to tell if you have this one

Check for part numbers 701072780 (Cardiohelp-i) or 701068550 (Slide Rail Holder) on the device. The serial numbers range from 90414355 to 90414868.

Brand
Maquet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device
Verify the part numbers and serial numbers on your Cardiohelp-i system to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 34 days after the firm started it.

Oct 12, 2023Firm started the recall
Nov 9, 2023FDA classified it Class II
Nov 15, 2023Published in FDA’s Enforcement Report

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

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Keep exploring

More Maquet recalls

Link to this recall

<a href="https://govinfonow.com/recall/57076-maquet-cardiohelp-i-blood-oxygen-system-recall-nut-bolt-breakage">Maquet Cardiohelp-i Blood Oxygen System Recall: Nut Bolt Breakage Risk (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-0290-2024 (October 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0290-2024 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.