Cardiac Oxygenator QUADROX-i Adult Recalled for Sterile Barrier Packaging Defects
Maquet is recalling QUADROX-i Adult cardiopulmonary bypass oxygenators (Models HMO 70000-USA and HMO 71000-USA) due to packaging defects including holes, cracks, and improper placement of accessories that may compromise sterility.
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 an FDA Class II recall of a critical medical device used in cardiac surgery. Although no illnesses have been reported, the failure mechanism (sterile barrier compromise) creates a significant risk of serious complications including sepsis and ischemia in vulnerable cardiac patients. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems USA is recalling QUADROX-i Adult cardiopulmonary bypass oxygenators, Models HMO 70000-USA (Item no. 701067820) and HMO 71000-USA (Item no. 701067823), all lots. These devices are used to supply oxygen and remove carbon dioxide during heart surgery.
The product packaging may exhibit holes, cracks, dents, and crushed areas. Additionally, an accessory may be improperly placed during packaging, causing creases and damage to the sterile pouch. Both issues can compromise the device's sterile barrier, potentially exposing the product to non-sterile conditions.
Exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia. These complications can occur in patients receiving cardiopulmonary bypass using affected devices.
The recalled product
- Product
- QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection
- sepsis
- ischemia
Distribution
Distributed nationwide across the United States.
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