EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER

FDA device recall Z-0979-2012 · posted 2012-02-07 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

Reason for recall

Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist

Action taken

Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information. For questions regarding this recall call 909-839-8604.

Root cause

Labeling design

Status

Terminated

Product code

OAE

Quantity affected

24,713 units in total

Distribution

Nationwide Distribution

Date initiated

2010-11-22

Date posted

2012-02-07

Date terminated

2012-02-08

Location

Irwindale, CA