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U.S. Department of Health and Human Services

Class 2 Device Recall Virtuoso II VR

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  Class 2 Device Recall Virtuoso II VR see related information
Date Initiated by Firm May 05, 2010
Date Posting Updated October 21, 2010
Recall Status1 Terminated 3 on March 15, 2012
Recall Number Z-0118-2011
Recall Event ID 55922
PMA Number P010031S125 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code NIK
Product Medtronic Virtuoso II VR, model D274VRC, and model D294VRC not available in the U.S.. Digital Single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA.
The Single chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single chamber rate-responsive bradycardia pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Code Information PZQ600556S, PZQ600557S, PZQ600559S thru PZQ600735S, PZQ600737S thru PZQ600822S, PZQ600825S thru PZQ600872S, PZQ600874S thru PZQ600911S, PZQ600913S thru PZQ600994S, PZQ600996S, PZQ600997S, PZQ600998S, PZQ600999S, PZQ601000S, PZQ601001S, PZQ601002S, PZQ601004S, PZQ601005S, PZQ601006S, PZQ601007S, PZQ601008S, PZQ601009S, PZQ601010S, PZQ601012S thru PZQ601170S, PZQ601172S thru PZQ601188S, PZQ601190S, PZQ601191S, PZQ601192S, PZQ601193S, PZQ601194S, PZQ601195S, PZQ601196S, PZQ601197S, PZQ601198S, PZQ601200S thru PZQ601251S, PZQ601253S, PZQ601254S, PZQ601255S, PZQ601256S, PZQ601258S thru PZQ601502S, PZQ601504S thru PZQ601594S, PZQ601596S, PZQ601597S, PZQ601598S, PZQ601599S, PZQ601600S..
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact
Manufacturer Reason
for Recall
Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u
FDA Determined
Cause 2
Software design
Action Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Quantity in Commerce 6674
Distribution Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.
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 = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT