UnratedMedical device recall · FDA · Published November 6, 2023
Maquet Cardiohelp-i Heart Lung Support System Recall: Incorrect Settings Risk
Maquet recalls Cardiohelp-i heart lung support systems with incorrect factory settings that could risk improper blood oxygenation. Affected units have specific part numbers and serial numbers up to 90415177.
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp
Take action
Contact the company
📍Recalling firmMaquet Medical Systems USA45 Barbour Pond Dr · Wayne, NJ 07470-2094
“Maquet Cardiohelp-i Heart Lung Support System Recall: Incorrect Settings Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56934-maquet-cardiohelp-i-heart-lung-support-system-recall-incorrect-settings. Based on FDA recall #Z-0555-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0555-2024%22&limit=1).
Maquet Medical Systems USA is voluntarily recalling CARDIOHELP-i Heart Lung Support Systems due to incorrect factory settings described in the instructions for use, according to the FDA. The recall was announced on November 6, 2023.
How to tell if you have it
Brand: Maquet Medical Systems
Product: CARDIOHELP-i Heart Lung Support System
Part Number: 701072780 (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)
Certain factory settings for the device were incorrectly described in the instructions for use related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor and the automatic lock in the Minimized Extracorporeal Circulation ThApp.
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 Spacelabs Healthcare Multi-parameter Command Module Model 91496 Recall (February 27, 2026), Medline Heart Cath Pack-LF Kits Recall (March 24, 2026), and Baxter Blue Ventilator Adapter Module Recall (February 18, 2026).
How to tell if you have this one
Check for part numbers 701072780 (US) or 701048012 (non-US) and serial numbers up to 90415177. The device is used for blood oxygenation and carbon dioxide removal during heart surgery.
Brand
Maquet Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the part number and serial number to confirm if your Cardiohelp-i system is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0555-2024 (November 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0555-2024 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.