Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are…

Date posted by the FDA

Nov. 3, 2005

Status

Terminated

Filed by

Remington Medical Inc.

Product

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, (770) 888-8520 or (800) 999-0057 * 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.

Distribution pattern

MN

Quantity

600 units

Codes and lots

Lot number: 051781, 051782, 051783, 051788, 0517939.

Recall started

Aug. 31, 2005

Device type

Tester, Pacemaker Electrode Function

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-0124-06

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0124-06. The agency record governs; check it and the company before acting.