Class 2 Device Recall Webster Biosense

• Date Initiated by Firm: July 16, 2004
• Date Posted: August 07, 2004
• Recall Status: Terminated 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: 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