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VISUALASE COOLED CATHETER LASER APPLICATOR (2016-05-27)
- Starting date:
- May 27, 2016
- Posting date:
- June 24, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59016
Affected products
A. VISUALASE COOLED CATHETER LASER APPLICATOR
Reason
Manufacturer received reports of melting of the VCLAS catheters during procedures to ablate tissue. Manufacturer revised the recommended treatment parameters and revised and added warnings accordingly.
Affected products
A. VISUALASE COOLED CATHETER LASER APPLICATOR
Lot or serial number
All lots
Model or catalog number
- T10: 001-4000 - VCLAS 001-4000 .4MM CORE FIBER 10M
- T15: 001-6000 - VCLAS 001-6000 .6MM CORE FIBER 15M
Companies
- Manufacturer
-
Medtronic Navigation
Inc.
826 Coal Creek Circle
Colorado
UNITED STATES