On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Quick Facts at a Glance
- Recall Date
- February 1, 2026
- Hazard Level
- HIGH
- Brand
- On-X Life Technologies
Hazard Information
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact On-X Life Technologies, Inc. or your healthcare provider for instructions. Notification method: Letter
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Full Description
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33. Reason: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.. Classification: Class II. Quantity: 10. Distribution: International distribution to the country of South Korea.
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