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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/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact Marcia S. Yaross, PhD
909-839-8998
Manufacturer Reason
for Recall		 Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
FDA Determined
Cause 2		 Other
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.
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