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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