This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Nc Trek Rx Coronary Dilation Catheters (2017-03-22)
- Starting date:
- March 22, 2017
- Posting date:
- April 4, 2017
- 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-62910
Affected Products
A. Nc Trek Rx Coronary Dilatation Catheter (2.75 Mm)
B. Nc Trek Rx Coronary Dilatation Catheter (3.00 Mm)
C. Nc Trek Rx Coronary Dilatation Catheter (3.25 Mm)
D. Nc Trek Rx Coronary Dilatation Catheter (3.50 Mm)
E. Nc Trek Rx Coronary Dilatation Catheter (3.75 Mm)
F. Nc Trek Rx Coronary Dilatation Catheter (4.00 Mm)
Reason
Abbott Vascular has initiated a field action for specific lots of the NC Trek RX coronary dilatation catheter. Product from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The worldwide frequency of tight sheath removal, inflation and deflation reported events is 0.12%.
Affected products
A. Nc Trek Rx Coronary Dilatation Catheter (2.75 Mm)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1012448-06
1012448-08
1012448-12
1012448-15
1012448-20
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES
B. Nc Trek Rx Coronary Dilatation Catheter (3.00 Mm)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1012449-06
1012449-08
1012449-12
1012449-15
1012449-20
1012449-25
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES
C. Nc Trek Rx Coronary Dilatation Catheter (3.25 Mm)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1012450-06
1012450-08
1012450-12
1012450-15
1012450-20
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES
D. Nc Trek Rx Coronary Dilatation Catheter (3.50 Mm)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1012451-06
1012451-08
1012451-12
1012451-15
1012451-20
1012451-25
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES
E. Nc Trek Rx Coronary Dilatation Catheter (3.75 Mm)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1012452-08
1012452-12
1012452-15
1012452-20
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES
F. Nc Trek Rx Coronary Dilatation Catheter (4.00 Mm)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1012453-08
1012453-12
1012453-15
1012453-20
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES