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U.S. Department of Health and Human Services

Class 2 Device Recall WEBSTER Fixed Curve Catheter with Auto ID Technology

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  Class 2 Device Recall WEBSTER Fixed Curve Catheter with Auto ID Technology see related information
Date Initiated by Firm April 17, 2015
Date Posted April 27, 2015
Recall Status1 Terminated 3 on December 10, 2015
Recall Number Z-1525-2015
Recall Event ID 71021
510(K)Number K892265  
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
Product 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
Code Information 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.
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact
909-839-8500
Manufacturer Reason
for Recall		 The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action 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.
Quantity in Commerce 503 units
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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