UnratedMedical device recall · FDA · Published November 14, 2023
Maquet Cardiohelp-i Heart Lung Support System Recall: Leakage Current Risk
Maquet recalls Cardiohelp-i heart lung support systems due to untested leakage current. This device pumps blood during surgery; affected units have specific serial numbers up to 90415172.
“Maquet Cardiohelp-i Heart Lung Support System Recall: Leakage Current Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56870-maquet-cardiohelp-i-heart-lung-support-system-recall-leakage-current. Based on FDA recall #Z-0595-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0595-2024%22&limit=1).
The FDA announced on November 14, 2023, that Maquet Medical Systems USA is recalling the CARDIOHELP-i Heart Lung Support System because it was not properly tested to measure leakage current. The recall affects 1,594 units distributed nationwide and internationally.
How to tell if you have it
Brand: Maquet
Product: CARDIOHELP-i Heart Lung Support System
REF Numbers: 701072780; 701048012
UDI-DI: 04058863074863; 04037691658384
Serial numbers up to and including 90415172
The hazard
The CARDIOHELP-i System was not properly tested to measure leakage current. This device is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support.
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 Medtronic Perfusion Systems EOPA Cannula Recall (June 24, 2026), the Medline Heart Cath Pack-LF Kits Recall (March 24, 2026), and the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026).
How to tell if you have this one
Check the serial number on the device, which should be up to and including 90415172. The product includes specific reference numbers: 701072780, 701048012, and UDI-DI codes 04058863074863 and 04037691658384.
Brand
Maquet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for the serial number on the device, which should be up to and including 90415172.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland,…” 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 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-0595-2024 (November 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0595-2024 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.