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Class 1 Recall: Medtronic Inc. Sprint Fidelis® Defibrillator Leads
Date Recall Initiated October 15, 2007
Product: Medtronic Inc. Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007.
Use: Leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that are used to treat abnormal heart rhythms that can cause the heart to stop suddenly.
Recalling Firm:
Medtronic Inc.
7000 Central Avenue
Minneapolis, Minnesota 55432-3576
Reason for Recall:
These leads are being recalled because a small number of fractures have been detected. When the lead breaks (fractures), it may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking.
FDA Comments:
Medtronic has advised doctors to stop implanting these leads and to return unused products to the firm.
Patients who are implanted with this lead or do not know the model of their lead, should contact their physicians for further information.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
Online:www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178