The Recall Desk
HighFDA (Devices)·Z-1659-2023·Announced 2023-06-07

QUADROX-i Adult Oxygenator Recalled for Packaging Defects Compromising Sterility

Maquet is recalling QUADROX-i Adult Oxygenators used in cardiopulmonary bypass surgery due to packaging defects that may compromise the sterile barrier. Contact with non-sterile devices could cause infection, sepsis, or ischemia.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall for a real packaging defect that compromises sterile barriers in a cardiac surgical device. While potential harms include serious complications like sepsis and ischemia, this is classified as High (not Severe) because it is a risk-of-harm recall without reported injuries documented in the source.

Plain-English summary

Maquet Medical Systems USA is recalling QUADROX-i Adult Oxygenators used during cardiopulmonary bypass procedures. The product packaging may contain small, non-visible pinholes that compromise the sterile barrier.

Affected models include HMO 70000-USA, HMO 71000-USA, and BEQ-HMO 71000-USA (all lots) with nationwide domestic distribution. Exposure to a non-sterile device may result in inflammation, infection, sepsis, or ischemia—serious complications in cardiac surgery patients.

This is an FDA Class II recall.

The recalled product

Product
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829
Manufacturer
Maquet Medical Systems USA
Category
Medical Device — Cardiac Surgery
Hazard
  • packaging-defect
  • infection
  • sepsis
  • ischemia

Distribution

Distributed nationwide across the United States.

Related recalls

Same category