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PentaRay NAV and PentaRay NAV ECO Catheter (2014-05-07)
- Starting date:
- May 7, 2014
- Posting date:
- June 5, 2014
- 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-39805
Recalled products
- PentaRay NAV Catheter
- PentaRay NAV ECO Catheter
Reason
Biosense Webster has identified an increase in reports of partial tip separation for the PentaRay NAV and PentaRay NAV ECO catheters. After conducting a root cause analysis, Biosense Webster has identified an issue in the production process that can lead to an insufficient bond of the distal tip to the catheter shaft which could pose a safety risk to the patient.
Affected products
A. PentaRay NAV Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- D128201
- D128202
- D128204
- D128205
Companies
- Manufacturer
-
Biosense Webster Inc.
3333 Diamond Canyon Road
Diamond Bar
91765
California
UNITED STATES
B. PentaRay NAV ECO Catheter
Lot or serial number
Not sold in Canada.
Model or catalog number
- D128207
- D128208
- D128210
- D128211
Companies
- Manufacturer
-
Biosense Webster Inc.
3333 Diamond Canyon Road
Diamond Bar
91765
California
UNITED STATES