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Thermocool Smarttouch Catheters (2013-09-04)
- Starting date:
- September 4, 2013
- Posting date:
- September 19, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-35717
Recalled Products
Thermocool SmartTouch Catheters
Reason
Biosense Webster has identified a defect in the production process of the Thermocool SmartTouch catheter which can lead to occlusion of the irrigation lumen. An irrigation fluid flow interruption has the potential to lead to overheating of the ablation tip and formation of char or thrombus, which in turn could pose a thromboembolic risk to the patient. All lots are being removed from the field.
Affected products
A. Thermocool Smarttouch Electro. Catheter
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
- D133601
- D133602
- D133603
Companies
- Manufacturer
-
Biosense Webster Inc.
3333 Diamond Canyon Road
Diamond Bar
91765
California
UNITED STATES
B. Thermocool Smarttouch Bi-Dir. Nav. Cath.
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
- D132701
- D132702
- D132703
- D132704
- D132705
Companies
- Manufacturer
-
Biosense Webster Inc.
3333 Diamond Canyon Road
Diamond Bar
91765
California
UNITED STATES