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Class 2 Device Recall WEBSTER Fixed Curve Catheter with Auto ID Technology |
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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
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Product Classification |
Catheter, electrode recording, or probe, electrode recording - Product Code DRF
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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
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For Additional Information Contact |
909-839-8500
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Manufacturer Reason for Recall |
The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
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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
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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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