Z-2313-2008

The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length...

Name: Z-2313-2008 The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length...
Creator: St. Jude Medical Cardiovascular Division
Published: 2008-06-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-06-05 / Terminated / root cause: labeling and UDI

FDA source

St. Jude Medical Cardiovascular Division began a recall of The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical... on 2008-06-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2313-2008
Status: Terminated
Initiated: 2008-06-05
Posted: 2008-09-20
Terminated: 2012-02-04
Recalling firm: Abbott Medical
Product: 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.
Product code: LPB Cardiac Ablation Percutaneous Catheter
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 39
Distribution: Canada and Belgium
Product codes and lots: Lot # 2056960

Product code LPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)