Z-0070-2008

Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular...

Name: Z-0070-2008 Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular...
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2007-10-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-10-15 / Terminated / root cause: design

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation... on 2007-10-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0070-2008
Status: Terminated
Initiated: 2007-10-15
Posted: 2007-10-25
Terminated: 2011-06-21
Recalling firm: Medtronic, Inc.
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.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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
Root cause tag: design
FDA root cause: Device Design
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.
Product codes and lots: all codes

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)