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Guider SoftTip XF
- Starting date:
- October 6, 2016
- Posting date:
- November 9, 2016
- 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-60948
Affected Products
Reason
Some potentially defective Guider guide catheter product. This product is manufactured by Boston Scientific and the defect was caused by a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Affected products
GUIDER SOFTIP XF
Lot or serial number
18829078
18831032
18904219
Model or catalog number
H965100440
M003101500
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES