Medtronic Sprint Fidelis Lead 의 리콜

Recall

45403

Class 1

Z-0067-2008

2007-10-15

2007-10-25

Terminated

United States

2011-06-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65383

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.

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.