7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St Jude Medic

FDA device recall Z-3257-2011 · posted 2011-09-16 · Terminated

Recall details

Recalling firm

St Jude Medical

Reason for recall

The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling, St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose, correct version.

Action taken

St. Jude Medical sent an "important Medical Device Safety Information" letter dated February 22, 2011 to all affected customers. The letter includes: affected problem, reconciliation form and corrective action. Customers are asked to remove the incorrect Instructions for Use (IFU) and use the IFU provided in the letter, and to fill out and return the reconciliation form. For questions on this recall please contact the firm at (512) 329-1054 or (651) 756-2869.

Root cause

Process control

Status

Terminated

Product code

LPB

Quantity affected

179 units total

Distribution

Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.

Date initiated

2011-02-10

Date posted

2011-09-16

Date terminated

2012-04-03

Location

Saint Paul, MN