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PentaRay High Density Catheters (2016-04-15)
- Starting date:
- April 15, 2016
- Posting date:
- April 29, 2016
- 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-58156
Affected Products
A. PENTARAY NAV HIGH DENSITY CATHETERS
B. PENTARAY NAV ECO HIGH DENSITY CATHETERS
Reason
Biosense Webster is clarifying the contraindication language in the instructions for use (IFU) and product labeling relative to patients with prosthetic valves. The current language states: "[The] use of this catheter may not be appropriate for use in patients with prosthetic valves." Biosense Webster is updating the IFU to clarify the contraindication statement as follows: "do not use PentaRay catheters in patients with prosthetic valves." this action is not a product removal.
Affected products
A. PENTARAY NAV HIGH DENSITY CATHETERS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
D128201
D128202
D128203
D128204
D128205
D128206
Companies
- Manufacturer
-
Biosense Webster Inc.
3333 Diamond Canyon Road
Diamond Bar
91765
California
UNITED STATES
B. PENTARAY NAV ECO HIGH DENSITY CATHETERS
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
D128207
D128208
D128209
D128210
D128211
D128212
Companies
- Manufacturer
-
Biosense Webster Inc.
3333 Diamond Canyon Road
Diamond Bar
91765
California
UNITED STATES