FDA-Device2026-05-20Class IIPROCESSING DEFECT
On-X Mitral Heart Valve with Conform-X Sewing Ring recalled due to incomplete testing
What this means
On-X Life Technologies released and distributed 10 mitral heart valves (Model ONXMC-25/33) before completing all required quality and performance testing. Because testing was incomplete, the company cannot confirm the valves meet all safety and performance specifications. The affected valves were distributed internationally to South Korea.
- If you received one of these valves, contact On-X Life Technologies or your healthcare provider immediately with the serial number.
- Do not implant affected valves. Check serial numbers A2013401–A2013411 against any inventory.
- Report any adverse events to the FDA MedWatch program.
The agency's original wording
Hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
International distribution to the country of South Korea.
Affected count
10
Manufactured in
1300 E Anderson Ln Ste B, Austin, TX, United States
Products
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2026Want us to check the next one for you?
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