Health product recall

NC Trek RX Coronary Dilatation Catheter (2020-01-29)

Starting date:
January 29, 2020
Posting date:
February 4, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72273

Last updated: 2020-02-04

Affected Products

NC Trek RX Coronary Dilatation Catheter

Reason

Devices from the identified lots may exhibit difficulty or inability to deflate the balloon due to weaker material proximal to the balloon bond resulting from excess heat exposure during manufacturing. The reported frequency of difficulty or inability to deflate the balloon for the affected population of lots is 0.09%.

Affected products

NC Trek RX Coronary Dilatation Catheter

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