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Rapid Exchange Turbo Elite Atherectomy Catheters
- Starting date:
- June 20, 2017
- Posting date:
- July 17, 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-63976
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
All lots
Model or catalog number
414-156
414-159
420-159
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES