Maquet recalls QUADROX-i Neonatal devices with specific part numbers due to potential blood leakage when using a reducing screw adapter, risking clinically relevant blood loss during patient connection.
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.
Maquet is recalling neonatal heart-lung machines that may leak blood when using a specific reducing screw adapter. This could cause blood loss during patient connection, which is serious for newborns.
The reducing screw adapter (1/4 x 3/16) can cause blood leakage at the blood inlet connector. This may lead to clinically significant blood loss before or during patient connection, which is dangerous for newborns.
Newborns undergoing heart surgery with the QUADROX-i Neonatal device are most at risk. Healthcare providers using the device with the specified part numbers are affected.
Check for the part number 701055207 on the QUADROX-i Neonatal device. The device was sold with specific lot numbers: 92209374, 92211752, 92215106, 92222131, 92223169, 92228805, 92234286, 92236876.
Look for part number 701055207 on the QUADROX-i Neonatal device.
The recall is due to a potential blood leakage risk at the blood inlet connector when using the reducing screw adapter (1/4 x 3/16), which could cause clinically relevant blood loss during patient connection.
The affected part number is 701055207. The device was sold with specific lot numbers: 92209374, 92211752, 92215106, 92222131, 92223169, 92228805, 92234286, 92236876.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0437-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0437-2019 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
