Maquet recalls Quadrox-i Neonatal without integrated arterial filter and VHK 11000 units with potential blood leakage at blood inlet connector using reducing screw adapter 1/4 x 3/16.
There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
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Contact the company
📍Recalling firmMaquet Cardiovascular Us Sales, Llc45 Barbour Pond Dr · Wayne, NJ 07470-2094
✎ GovInfoNow plain-language explainer
Maquet is recalling certain Quadrox-i Neonatal without integrated arterial filter and VHK 11000 units due to a risk of blood leakage at the blood inlet connector when using a specific reducing screw adapter. This could lead to clinically significant blood loss during patient connection or loss of prime before patient connection. Read more at govinfonow.com/recall/69552-maquet-quadrox-i-neonatal-recall-blood-leakage-risk-with-reducing.
“Maquet Quadrox-i Neonatal Recall: Blood Leakage Risk with Reducing Screw Adapter.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69552-maquet-quadrox-i-neonatal-recall-blood-leakage-risk-with-reducing. Based on FDA recall #Z-0436-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0436-2019%22&limit=1).
The FDA announced on 2018-10-25 that Maquet Cardiovascular Us Sales, Llc is recalling QUADROX-i Neonatal oxygenators and VHK 11000 parts due to potential blood leakage at the inlet connector. The recall affects 490 units distributed worldwide.
How to tell if you have it
Brand: Maquet
Product: QUADROX-i Neonatal without integrated arterial filter; Part Number 701055120
According to the FDA, there is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16. This may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
Context
GovInfoNow's records show Maquet Cardiovascular Us Sales, Llc has 14 other recalls on record since 2019-02-08. Other recent recalls include the 2020-11-20 Maquet HLS Set Advanced 7.0 Recall for sterility barrier breaches and the 2020-09-30 Maquet BMU 40 Blood Monitor Recall for PCBA short creepage risk. Other recent recalls of similar products include the 2026-08-10 Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall and the 2026-05-25 Medtronic Pediatric Cannula Recall.
How to tell if you have this one
Check for the Quadrox-i Neonatal without integrated arterial filter and VHK 11000 units with part number 701055120. The units were sold in lots 92212343, 92214685, and 92225187.
Brand
Maquet
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
Distribution
Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, IA, LA, NC, and TX and countries of: Canada, Argentina, Brazil, Chile, Colombia, Mexico, Uruguay, United Arab Emirates, Belgium, Switzerland, Germany, Egypt, Spain, France, United Kingdom, Ireland, Italy, Lebanon, Netherlands, Pakistan, Portugal, Reunion, Saudi Arabia, Sweden, South Africa, Poland, Serbia, Russia, Turkey, Ukraine, China, India, Japan, Republic of Korea (South Korea), Malaysia, Thailand, and Taiwan.
Recall number
Product, codes & lots
Z-0436-2019
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.; UDI: 04037691780139; Lots: 92212343, 92214685, 92225187
Z-0437-2019
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.; UDI: 04037691773414; Lots: 92209374, 92211752, 92215106, 92222131, 92223169, 92228805, 92234286, 92236876
Based on the official FDA remedy
What to do — step by step
Check for Recalled Units
Identify units with part number 701055120 from lots 92212343, 92214685, or 92225187.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, IA, LA, NC, and TX and countries of: Canada, Argentina, Brazil, Chile, Colombia, Mexico, Uruguay, United Arab Emirates, Belgium, Switzerland, Germany, Egypt, Spain, France,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Iowa, Louisiana, North Carolina, Texas.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0436-2019 (October 25, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0436-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.