Medtronic Sprint Quattro Secure, model 6947. Steroid eluting, quadripolar, screw-in, ventricular lead with Right Ventric

FDA device recall Z-0475-2011 · posted 2010-11-26 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Managment

Reason for recall

Over-retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. This does not impact acute or chronic performance of successfully implanted leads.

Action taken

Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead. Customers can contact Medtronic Technical Services at 800 723-4636

Root cause

Device Design

Status

Terminated

Product code

LWS

Quantity affected

154,000 total

Distribution

Worldwide Distribution: Throughout the US, including Guam, Puerto Rico, and US Virgin Islands, and to the countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bangladesh, Barbados,

Date initiated

2010-10-25

Date posted

2010-11-26

Date terminated

2012-02-04

Location

Saint Paul, MN