The St. Jude Medical Livewire TC" Ablation Catheter, 8mm… recallZ-2313-2008 · St. Jude Medical Cardiovascular Division · initiated Jun 5, 2008
Terminated All recalls posted in September 2008
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 St. Jude Medical Cardiovascular Division 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
St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum at the tip electrode. If this coagulum were to detach from the product, the worst case this could potentially result in embolization.
FDA root cause category: Labeling mix-ups
What the company is doing
Consignees were sent a "St Jude Medical Urgent Product Recall" letter addressed to "Dear Doctor" and a "Doctor's Acknowledgement Form" . The letter described the product, problem and the possibility of a health hazard. They also requested discontinue of product and gave instructions for return of product. Contact St. Jude Medical at 952-933-4700 if you have questions.
Recall details
- Recall number
- Z-2313-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 5, 2008
- Posted by the FDA
- Sep 20, 2008
- Recalling firm
- St. Jude Medical Cardiovascular Division
- Quantity
- 39
- Product code
- LPB
- FDA submissions
- P960016
- Distribution
- Canada and Belgium
Product description
The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO The St. Jude Medical Livewire TC" Ablation Catheter is a flexible electrode catheter constructed of a radiopaque polyurethane insulation/shaft and incorporated platinum electrode. The distal tip portion may be deflected by a remote control handle located a t the proximal end of t the catheter.
Code information (models, lots, serial numbers)
Lot # 2056960
Other devices under the same FDA submission
7 devices cleared under P960016 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Safire™ 402810St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter12 reports
- Safire™ 402811St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter9 reports
- Safire™ 402807St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter7 reports
- Livewire™ 402151St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter4 reports
- Livewire™ 402152St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter2 reports
- Safire™ 402806St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter2 reports
- Safire™ 402808St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter1 report
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.
How recalls are matched to devices · Editorial policy · Report an error on this page