This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
OVER-THE-WIRE SELF-EXPANDING STENT SYSTEM (2017-11-07)
- Starting date:
- November 7, 2017
- Posting date:
- November 24, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-65170
Affected products
OVER-THE-WIRE SELF-EXPANDING STENT SYSTEM
Reason
Elevated complaint rates for partial stent deployment. Partial deployment occurs when the stent is unable to be fully released from the delivery system. Part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system
Affected products
OVER-THE-WIRE SELF-EXPANDING STENT SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H74939180052070
H74939180062070
H74939180072070
H74939181052030
H74939181062030
H74939181072030
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES