Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, [phone] or [phone] * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.

Recall

• Recall Number: Z-0124-06
• Event Number: 33490
• Firm: Remington Medical Inc.
• FEI Number: 1000132370
• Product Code: DTA
• Status: Terminated
• Root Cause: Other
• Initiated: August 31, 2005
• Posted: November 3, 2005
• Terminated: May 9, 2007
• Address: 6830 Meadowridge Ct, Alpharetta, GA, 30005-2202

Description

Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, [phone] or [phone] * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.

Reason

The vector selector has an electrical design flaw which prevents RV pacing.

Action

Guidant Corporation notified Remington Medical of the problem. Remington had instructed Guidant to retrieve the product from their sales force by 09/07/2005 and return to Remington by 09/09/2005.

Distribution

MN

Quantity

600 units

Device

• Product Code: DTA
• Device: Tester, Pacemaker Electrode Function
• Class: Class 2
• Specialty: Cardiovascular