QUADROX-i Pediatric Oxygenators Recalled for Packaging Sterility Defects
QUADROX-i Pediatric Oxygenators used in cardiopulmonary bypass surgery are recalled for packaging defects that may compromise sterility, potentially causing inflammation, 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: No illnesses or injuries are reported. This is a risk-of-harm medical device with potential for serious consequences (sepsis, ischemia) but without reported incidents. This meets High severity criteria.
Plain-English summary
Maquet Medical Systems USA is recalling QUADROX-i Pediatric Oxygenators used during cardiopulmonary bypass surgery. The affected models are HMO 30000-USA (Item No. 701070384) and HMO 31000-USA (Item No. 701070388), with all lots distributed nationwide.
The product packaging may contain small pinholes that are not visible to the naked eye. These defects compromise the sterile barrier of the packaging, potentially exposing the device to non-sterile conditions.
Exposure to a non-sterile device may result in inflammation, infection, sepsis, and ischemia in patients undergoing cardiopulmonary bypass surgery who receive the affected device.
The recalled product
- Product
- QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
- Manufacturer
- Maquet Medical Systems USA
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Maquet Medical Systems USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Maquet Medical Systems USA
See all →- HighCARDIOHELP-i System Recalled for Elevated Patient Leakage Current
FDA (Devices) · 2024-05-22
- HighFDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect
FDA (Devices) · 2024-02-21
- HighMedical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect
FDA (Devices) · 2024-02-21
- HighRotaFlow Centrifugal Pump Seal Defect Poses Infection Risk
FDA (Devices) · 2024-02-14
- ModerateBubble Sensor for CARDIOHELP-i system has incorrect device identifier on label
FDA (Devices) · 2024-02-14
Same hazard · sterile barrier defect
See all →- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighPruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2025-05-21
- HighPruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
FDA (Devices) · 2025-05-21
- HighB Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall
FDA (Devices) · 2025-05-14
- HighSocrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
FDA (Devices) · 2025-03-05