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Express LD Iliac/Biliary Premounted Stent System
- Starting date:
- December 19, 2016
- Posting date:
- January 12, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61770
Reason
Boston Scientific is implementing this medical device correction on certain lots of the Express LD Biliary Stent due to incorrect electronic directions for use (e-DFU), impacting Canada only. The e-DFU card included with these products refers to the U.S. e-DFU on the Boston Scientific e-Labeling website, which currently contains indications that are not approved by Health Canada. No adverse health consequence is reasonably expected to occur and no complaints have been received to date.
Affected products
Express LD Iliac/Biliary Premounted Stent System
Lot or serial number
17922271
18032680
18032682
18068984
19200184
19321955
19394085
19472345
19544802
19808367
Model or catalog number
H74938046530750
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES