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Abbott Hi-Torque Connect Guidwires (2013-11-25)
- Starting date:
- November 25, 2013
- Posting date:
- November 29, 2013
- 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-37027
Recalled products
- Abbott Hi-Torque Connect Straight Guidewires
- Abbott Hi-Torque Connect Flex Straight Guidewires
- Abbott Hi-Torque Connect 250t Straight Guidewires
Reason
A small number of HT Connect peripheral guide wires have exhibited partial delamination of the PTFE coating. To date, the frequency of worldwide reported incidents of delamination of the coating is 0.08%. While there have been no long term or irreversible patient effects reported, potential risks associated with delamination of the coating include embolism, thrombus and occlusion in peripheral vessels.
Affected products
A. Abbott Hi-Torque Connect Straight Guidewires
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 1012587
- 1012588
- 1012589
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES
B. Abbott Hi-Torque Connect Flex Straight Guidewires
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 1012590
- 1012591
- 1012592
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES
C. Abbott Hi-Torque Connect 250T Straight Guidewires
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 1012593
- 1012594
- 1012595
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES