Reported Sep 21, 2016 · Terminated
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3…
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?
- CARTO 3 EP Navigation System and Accessories
- Product CodesFG540000 and FG540000C
- Software Versionsv 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure
- Lot codes and dates
65 of 65 codes
V 3.2: 225810284103321034511640116426001160012606066061160613606186062160625606346064460651606546065760658606606066160664606716067360674606806068260683610006100261005610106101461038610396104161045610466105061055610606106261064610716150166114661156611766118661192930613173132131156714528 V 4.3: 6105361054610591170112664 V 2.3: 14218
- Amount recalled
- 338 units
Why it was recalled
Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
This product could cause temporary or reversible health problems — stop using it.
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