Biosense Webster, Inc. Stockert 70 Radio Frequency Ablation Generator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stockert 70 Radio Frequency Ablation Generator
Brand
Biosense Webster, Inc.
Lot Codes / Batch Numbers
Al generators except with version 1.034B
Products Sold
Al generators except with version 1.034B
Biosense Webster, Inc. is recalling Stockert 70 Radio Frequency Ablation Generator due to Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026