THERMOCOOL SMARTTOUCH SF Uni-Directional and Bi-Directional Navigation Catheter (2018-10-20)
- Starting date:
- October 20, 2018
- Posting date:
- November 28, 2018
- 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-68428
Affected products
- THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter
- THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter
Reason
Through the post-market surveillance process, Biosense Webster Inc. has observed a higher than expected reported rate of char formation for the ThermoCool SmartTouch SF Uni-Directional Catheter and the ThermoCool SmartTouch SF Bi-Directional Navigation Catheter. Although char formation by itself is not a patient adverse event, in rare circumstances it has the potential to contribute to patient adverse events
Affected products
A. THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter
Lot or serial number
- D134701
- D134702
- D134703
Model or catalog number
- D134701
- D134702
- D134703
Companies
- Manufacturer
-
Biosense Webster Inc.
33 Technology Dr.
Irvine
92618
California
UNITED STATES
B. THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter
Lot or serial number
- D134801
- D134802
- D134803
- D134804
- D134805
Model or catalog number
- D134801
- D134802
- D134803
- D134804
- D134805
Companies
- Manufacturer
-
Biosense Webster Inc.
33 Technology Dr.
Irvine
92618
California
UNITED STATES