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U.S. Department of Health and Human Services

Class 2 Device Recall Webster Biosense

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  Class 2 Device Recall Webster Biosense see related information
Date Initiated by Firm July 16, 2004
Date Posted August 07, 2004
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-1328-04
Recall Event ID 29591
PMA Number P990071 
Product Classification Catheter, Electrode Recording, Or Probe, Electrode Recording - Product Code DRF
Product Stockert 70 Radio Frequency Ablation Generator
Code Information Al generators except with version 1.034B
Recalling Firm/
Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact Marcia S. Yaross, PhD
Manufacturer Reason
for Recall
Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
FDA Determined
Cause 2
Action Customers were instructed to suspend use of the generators with software version 1.033 until they are upgraded with version 1.034B in a letter dated 7/15/2004. Firm issued a second letter on 9/17/04 for a software error discovered in-house during the upgrade. It instructs a workaround solution to prevent unwanted activity of the catheter.
Quantity in Commerce unknown, not stated.
Distribution Nationwide
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.
PMA Database PMAs with Product Code = DRF and Original Applicant = BIOSENSE WEBSTER, INC.