Reported May 6, 2015 · Terminated
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation…
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?
- WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only
- Catalog No01085413
- Lot codes and dates
Lot No. 17147443M17177237M17196045M17142745M17176185M17191133M17177957M17162927M17163734M17159129M17157116M17144954M17192170M17192723M17173428M17174967M17174968M17194186M17194707M17153400M17154595M17176186M17142888M17167809M17167282M17158235M17159407M17151134M17154141M17176477M17176478M17172465M17145731M17146665M17172058M
- Amount recalled
- 503 units
Where it was sold
- Nationwide
Why it was recalled
The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Biosense Webster, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.