This page has been archived on the Web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.
Rapid Exchange Turbo Elite Atherectomy Catheters
- Starting date:
- June 20, 2017
- Posting date:
- July 11, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Laceration Hazard
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63900
Reason
Potential for fluoroscopically visible marker band at tip of device to become loose or disengaged from catheter when device is used in an off-label manner
Affected products
Rapid Exchange Turbo Elite Atherectomy Catheters
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
414-156
414-159
420-159
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES