Health product recall

On-X Conform-X Prosthetic Heart Valve - Aortic with Extended Valve Holder, Mitral, Aortic and On-X Prosthetic Heart Valve - Aortic, Mitral, On-X Prosthetic Heart Valve - Aortic with Extended Valve Holder, and On-X Aortic Prosthetic Heart Valve with A...

Starting date:
March 13, 2018
Posting date:
April 24, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66534

Affected products

  1. On-X Conform-X Prosthetic Heart Valve - Aortic with Extended Valve Holder
  2. On-X Prosthetic Heart Valve - Aortic with Extended Valve Holder
  3. On-X Prosthetic Heart Valve - Aortic
  4. On-X Prosthetic Heart Valve - Mitral
  5. On-X Conform-X Prosthetic Heart Valve - Mitral
  6. On-X Conform-X Prosthetic Heart Valve - Aortic
  7. On-X Aortic Prosthetic Heart Valve with Anatomic Sewing Ring

Reason

The Medicines & Healthcare products Agency (MHRA) became aware of five (5) incidents worldwide over the last fifteen (15) years where mechanical bileaflet prosthetic valves were reported to have been implanted in an inverted position because they were put in their holder upside down. The 5 reported incidents were not associated with On-X heart valves. To date, On-X Life Technologies, Inc. has received one related report. No Product is subject to removal or correction in the field. A field safety notice will be transmitted to all relevent personnel who handle and implant the On-X Valve Device.

Affected products

A. On-X Conform-X Prosthetic Heart Valve - Aortic with Extended Valve Holder

Lot or serial number

All lots.

Model or catalog number

ONXACE

Companies
Manufacturer
On-X Life Technologies, Inc.
1300 East Anderson Lane
Austin
78752
Texas
UNITED STATES

B. On-X Prosthetic Heart Valve - Aortic with Extended Valve Holder

Lot or serial number

All lots.

Model or catalog number

ONXAE

Companies
Manufacturer
On-X Life Technologies, Inc.
1300 East Anderson Lane
Austin
78752
Texas
UNITED STATES

C. On-X Prosthetic Heart Valve - Aortic

Lot or serial number

All lots.

Model or catalog number

ONXA

Companies
Manufacturer
On-X Life Technologies, Inc.
1300 East Anderson Lane
Austin
78752
Texas
UNITED STATES

D. On-X Prosthetic Heart Valve - Mitral

Lot or serial number

All lots.

Model or catalog number

ONXM

Companies
Manufacturer
On-X Life Technologies, Inc.
1300 East Anderson Lane
Austin
78752
Texas
UNITED STATES

E. On-X Conform-X Prosthetic Heart Valve - Mitral

Lot or serial number

All lots.

Model or catalog number

ONXMC

Companies
Manufacturer
On-X Life Technologies, Inc.
1300 East Anderson Lane
Austin
78752
Texas
UNITED STATES

F. On-X Conform-X Prosthetic Heart Valve - Aortic

Lot or serial number

All lots.

Model or catalog number

ONXAC

Companies
Manufacturer
On-X Life Technologies, Inc.
1300 East Anderson Lane
Austin
78752
Texas
UNITED STATES

G. On-X Aortic Prosthetic Heart Valve with Anatomic Sewing Ring

Lot or serial number

All lots.

Model or catalog number
  • ONXAN
  • ONXANE
Companies
Manufacturer
On-X Life Technologies, Inc.
1300 East Anderson Lane
Austin
78752
Texas
UNITED STATES