The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot

FDA device recall Z-2313-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

St. Jude Medical Cardiovascular Division

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

LPB

Quantity affected

39

Distribution

Canada and Belgium

Date initiated

2008-06-05

Date posted

2008-09-20

Date terminated

2012-02-04

Location

Minnetonka, MN