US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled RE

FDA device recall Z-0174-2014 · posted 2013-11-06 · Terminated

Recall details

Recalling firm

St. Jude Medical

Reason for recall

St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).

Action taken

The firm, St. Jude Medical (SJM), sent a "Urgent Medical Device Notice" dated 11 October 2013 to its consignees. The letter described the problem, the product involved in the recall and the actions to be taken. The consignees were instructed to discard the IFU received with the batches and replace it with the IFU received in conjunction with the notification letter. SJM has determined that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU. If you have any questions, contact Vice President, Quality, at 651-756-5402.

Root cause

Error in labeling

Status

Terminated

Product code

OAD

Quantity affected

59

Distribution

US distribution: KS, MA, UT,TX, KY, OH.

Date initiated

2013-10-11

Date posted

2013-11-06

Date terminated

2016-03-10

Location

Plymouth, MN