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Everflex Self-Expanding Peripheral Stent With Entrust (2013-09-12)
- Starting date:
- September 12, 2013
- Posting date:
- October 16, 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-36219
Recalled Products
Everflex Self-Expanding Peripheral Stent With Entrust
Reason
Covidien Canada is conducting a field safety corrective action for a specific lot of Everflex self expanding peripheral stent with entrust delivery system because of reported deployment issues. The 200 mm Everflex Entrust have a higher rate of stent deployment difficulties 16 tight lesions or torturous anatomy.
Affected products
Everflex Seif-Expanding Peripheral Stent With Entrust
Lot or serial number
- 9774961
Model or catalog number
- EVX35-06-200-120
Companies
- Manufacturer
-
EV3 Inc.
4600 Nathan Lane North
Plymouth
55442
Minnesota
UNITED STATES