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Alligator Retrieval Device (2014-04-03)
- Starting date:
- April 3, 2014
- Posting date:
- April 15, 2014
- 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-39099
Recalled products
- Alligator Retrieval Device
Reason
Covidien identified one component lot of delivery wires used in the alligator retrieval device that has a potential for the PTFE (polyetrafluoroethylene) coating to delaminate and detach from the delivery wire. PTFE particulate resulting from delaminated coating may lead to embolic occlusion of the cerebral vasculature.
Affected products
A. Alligator Retrieval Device
Lot or serial number
- 9774620
- 9758532
- 9783730
- 9798648
- 9834039
- 9764206
- 9764212
- 9786013
- 9801041
Model or catalog number
- FA-88810-20
- FA-88810-30
- FA-88810-40
- FA-88810-50
Companies
- Manufacturer
-
Micro Therapeutics Inc.
Dba Ev3 Neurovascular
9775 Toledo Way
Irvine
92618
California
UNITED STATES