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ATLAS GOLD PTA DILATATION CATHETER (2017-10-10)
- Starting date:
- October 10, 2017
- Posting date:
- October 20, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64906
Affected products
ATLAS GOLD PTA DILATATION CATHETER
Reason
To inform customers that specific product code / lot number combinations may be at risk of having a balloon wall thickness that is higher than the required specification, which could result in a slight increase in the force required to advance the balloon through the sheath and/or withdraw the balloon after inflation and deflation, and could potentially lead to a slight prolongation of the procedure. Potentially, there may also be an increase in the balloon's non-compliance and rigidity. Product return is not required.
Affected products
ATLAS GOLD PTA DILATATION CATHETER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- ATG120162
- ATG120182
- ATG120184
- ATG120202
- ATG120244
- ATG80164
- ATG80202
- ATG80222
Companies
- Manufacturer
-
Bard Peripheral Vascular Inc.
1625 West 3rd Street
Tempe
55441
UNITED STATES