Stockert 70 Radio Frequency Ablation Generator recallZ-1328-04 · Biosense Webster, Inc. · initiated Jul 16, 2004
Terminated All recalls posted in August 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1328-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 16, 2004
- Posted by the FDA
- Aug 7, 2004
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- unknown, not stated.
- Product code
- DRF
- FDA submissions
- P990071
- Distribution
- Nationwide
Product description
Stockert 70 Radio Frequency Ablation Generator
Code information (models, lots, serial numbers)
Al generators except with version 1.034B
Other devices under the same FDA submission
5 devices cleared under P990071 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
- nGEN Generator D138402Biosense Webster Inc · Cardiac ablation percutaneous catheter2 deaths46 reports
- nGEN Pump D139702Biosense Webster Inc · Cardiac ablation percutaneous catheter17 reports
- CoolFlow CFT001Biosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 reports
- CoolFlow CFP002Biosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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