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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Virtuoso

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  Class 2 Device Recall Medtronic Virtuoso see related information
Date Initiated by Firm July 27, 2009
Date Posted August 18, 2009
Recall Status1 Terminated 3 on May 31, 2012
Recall Number Z-1954-2009
Recall Event ID 52853
PMA Number P980016S062 
Product Classification Implantable cardioverter defibrillator (Single Chamber) - Product Code LWS
Product Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.

This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure.
Code Information Serial number: PUN421618H.
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St. N.E.
Mounds View MN 55112
For Additional Information Contact
763-514-4000
Manufacturer Reason
for Recall		 Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto, Virtuoso and EnRhythm family of devices. The probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant.
FDA Determined
Cause 2		 Process control
Action Medtronic, Inc. personnel retrieved 2 non-implanted devices remaining at 2 hospitals. A Performance Notes letter was left at each facility. The Performance Notes described the issue, actions to address issue and recommendations to physicians. The Performance Notes will also be posted on the firm's website. Direct questions about this recall to Medtronic, Inc. by calling 1-763-514-4000.
Quantity in Commerce 1
Distribution Nationwide Distribution-- (states of IA and NJ).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.
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