FDA Medical Device Recalls (openFDA)
Biosense Webster, Inc.: Stockert 70 Radio Frequency Ablation Generator
- Recall number
- Z-1328-04
- Recalling firm
- Biosense Webster, Inc.
- Product
- Stockert 70 Radio Frequency Ablation Generator
- Status
- Terminated
- Initiated
- 2004-07-16
- Posted
- 2004-08-07
- Terminated
- 2012-05-07
- Reason
- Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
- Root 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
- unknown, not stated.
- Distribution
- Nationwide
- Lot, serial or model codes
- Al generators except with version 1.034B
- 510(k) numbers
- not on file
- PMA numbers
- ["P990071"]
- Product code
- DRF
- Firm FEI
- 3003113629
- Firm city
- Irwindale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28