Reported Nov 8, 2017 · Terminated
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Biosense Webster, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster, Inc. · 15715 Arrow Hwy · Irwindale, CA · 91706-2006
Is this the product you have?
- THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
- Lot codes and dates
17688816M17697930M17697966M
- Amount recalled
- 19 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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