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CHARIOT GUIDING SHEATH (2015-11-19)
- Starting date:
- November 19, 2015
- Posting date:
- December 22, 2015
- 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-56412
Recalled Products
A. CHARIOT GUIDING SHEATH
Reason
Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. The most severe outcome of this failure is embolism of device fragments.
Affected products
A. CHARIOT GUIDING SHEATH
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- H74939277545110
- H74939277645110
- H74939277645120
- H74939277665110
- H74939277690110
- H74939277745110
- H74939277745210
- H74939277845110
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marborough
01752
Massachusetts
UNITED STATES