Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) /

FDA device recall Z-0069-2008 · posted 2007-10-25 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Managment

Reason for recall

Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of

Action taken

A press release was issued by Medtronic on 10/15/2007. An FDA Statement was also issued on 10/15/2007. An Urgent Medical Device Information letter, dated 10/15/2007, was sent to physicians. The letter states that Medtronic has suspended distribution of the leads, the leads should no longer be implanted and unused leads should be returned to Medtronic. This letter describes background information, performance and recommendations. Medtronic believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances. An Important Patient Information letter was addressed to Medtronic Heart Device Patients. Both letters can be found on Medtronic's website at www.medtronic.com/fidelis. Return of product will be achieved with the assistance of Medtronic Representatives.

Root cause

Device Design

Status

Terminated

Product code

LWS

Quantity affected

235,000 for all models

Distribution

Worldwide, including USA, Puerto Rico, Guam, and Northern Mariana Islands.

Date initiated

2007-10-15

Date posted

2007-10-25

Date terminated

2011-06-21

Location

Minneapolis, MN