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Medical Device Recalls
Class 1 Recall
Medtronic Sprint Fidelis Lead

See Related Information
Date Recall
Initiated		 October 15, 2007
Date Posted October 25, 2007
Recall Number Z-0070-2008
Product Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies. Medtronic World Headquarters, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
Code Information all codes
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave Ne
Minneapolis , Minnesota 55432-3568
For Addition Information Contact Medtronic Patient Services
800-551-5544 Ext. 41835
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 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.
Quantity in Commerce 235,000 for all models
Distribution Worldwide, including USA, Puerto Rico, Guam, and Northern Mariana Islands.
 

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