WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
This recall has been terminated (originally issued April 27, 2015).
- Company
- Biosense Webster, Inc.
- Recall Initiated
- April 17, 2015
- Posted
- April 27, 2015
- Terminated
- December 10, 2015
- Recall Number
- Z-1525-2015
- Quantity
- 503 units
- Firm Location
- Irwindale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
Distribution
US nationwide distribution.
Lot / Code Info
Lot No. 17147443M, 17177237M, 17196045M, 17142745M, 17176185M, 17191133M, 17177957M, 17162927M, 17163734M, 17159129M, 17157116M, 17144954M, 17192170M, 17192723M, 17173428M, 17174967M, 17174968M, 17194186M, 17194707M, 17153400M, 17154595M, 17176186M, 17142888M, 17167809M, 17167282M, 17158235M, 17159407M, 17151134M, 17154141M, 17176477M, 17176478M, 17172465M, 17145731M, 17146665M, 17172058M.
Root Cause
Software Manufacturing/Software Deployment
Action Taken
A recall letter dated 4/17/15 will be sent to customers by FedEx to inform them that Biosense Webster is recalling Webster HIS catheter, 4Pole Fixed Curve with Auto ID (Catalog No. D1085413). The letter informs the customers of the problems identified and the actions to be taken. Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7:00AM to 8:00PM EST. Customers with questions related to the Voluntary Recall Certification Form and the process for returning the form, are instructed contact Elie Ghattas, Field Action Coordinator, at (909) 839-7281.