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On-X Mitral Heart Valve with Standard Sewing Ring ONXM-31/33

by On-X Life Technologies, Inc.

Ref ONXM-31/33

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00851788001297 Basic UDI-DI 00851788001297UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00851788001297 UDI-DI Date12 Sep 2014ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2133-2026 FDA Class II initiated 1 Feb 2026

    Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

    • Terminated Z-1073-2019 FDA Class II initiated 17 Jan 2019

    On-X Valve was mislabeled with the incorrect serial number.

    • Terminated Z-2715-2017 FDA Class II initiated 12 Jun 2015

    Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.

    • Terminated Z-3108-2017 FDA Class II initiated 12 Feb 2014 on shared PMA P000037

    Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
On-X Prosthetic Heart Valve EUDAMED
On-X Mitral Heart Valve with Standard Sewing Ring GUDID
Generic Name
Mitral bi-leaflet mechanical heart valve prosthesis
Model / Reference
ONXM-31/33
Primary DI / UDI-DI
00851788001297
Basic UDI-DI
B-00851788001297
PMA Number
FDA Product Code
LWQ
EMDN Code
P0703020302 Bileaflet mechanical mitral valves
GMDN Term
Mitral bi-leaflet mechanical heart valve prosthesis
Device Class
Class III
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Outer Diameter — 33 Millimeter

Related devices

Cleared under the same submission (P000037)

Show all (12)

Other devices from On-X Life Technologies, Inc.

See all devices from On-X Life Technologies, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (16)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No