On-X Mitral Heart Valve Model ONXMC-25/33 Released Without Complete Testing
On-X Life Technologies is recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33, because the valves were distributed before all required testing was complete, preventing confirmation that they meet all release specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a critical life-sustaining implantable device (heart valve) that was distributed without completion of required testing. The inability to confirm the valve meets all release specifications represents a significant potential risk for an implanted cardiac device.
Plain-English summary
On-X Life Technologies, Inc. is recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33. The recall affects 10 units distributed internationally to South Korea.
The valves were released and distributed before all required testing was completed. Because testing was incomplete, it cannot be confirmed that the heart valves meet all required release specifications.
Patients and healthcare providers who have received or implanted these valves should contact On-X Life Technologies, Inc. for further guidance. The affected serial numbers are A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, and A2013411, with an expiration date of December 17, 2031.
The recalled product
- Product
- On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Manufacturer
- On-X Life Technologies, Inc.
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- UDI-DI: 00851788001303. Serial Numbers: A2013401
- A2013402
- A2013403
- A2013404
- A2013405
- A2013407
- A2013408
- A2013409
- A2013410
- A2013411. Expiration: 2031Dec17
Distribution
Distribution scope not specified by the agency.
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