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
- On-X Conform-X Prosthetic Heart Valve - Aortic with Extended Valve Holder
- On-X Prosthetic Heart Valve - Aortic with Extended Valve Holder
- On-X Prosthetic Heart Valve - Aortic
- On-X Prosthetic Heart Valve - Mitral
- On-X Conform-X Prosthetic Heart Valve - Mitral
- On-X Conform-X Prosthetic Heart Valve - Aortic
- 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