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U.S. Department of Health and Human Services

Class 2 Device Recall Secura VR

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 Class 2 Device Recall Secura VR see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0116-2011
Recall Event ID 55922
PMA Number P980016S114 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product Medtronic Secura VR, model D224VRC, and model D234VRC 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 Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Code Information PZF600638S, PZF600639S, PZF600640S, PZF600641S, PZF600642S, PZF600643S, PZF600644S, PZF600645S, PZF600647S thru PZF600668S, PZF600686S thru PZF600748S, PZF600750S thru PZF600825S, PZF600827S thru PZF600875S, PZF600881S thru PZF600917S, PZF600919S thru PZF601064S, PZF601066S thru PZF601092S, PZF601094S thru PZF601193S, PZF601195S thru PZF601358S, PZF601384S, PZF601385S, PZF601386S, PZF601387S, PZF601388S, PZF601389S, PZF601391S thru PZF601489S, PZF601491S thru PZF601627S, PZF601629S thru PZF601673S, PZF601675S, PZF601676S, PZF601677S, PZF601678S, PZF601679S, PZF601680S, PZF601681S, PZF601683S thru PZF601774S, PZF601776S thru PZF601845S, PZF601847S thru PZF601899S, PZF601901S, PZF601903S, PZF601904S, PZF601905S, PZF601906S, PZF601907S, PZF601908S, PZF601909S, PZF601910S, PZF601912Sthru PZF602056S, PZF602058S thru PZF602121S, PZF602123S thru PZF602154S, PZF602156S thru PZF602188S, PZF602190S thru PZF602206S, PZF602208S thru PZF602507S, PZF602509S thru PZF602531S, PZF602532S, PZF602533S, PZF602534S, PZF602535S, PZF602536S, PZF602537S, PZF602539S thru PZF602576S, PZF602578S thru PZF602638S, PZF602640S thru PZF602665S, PZF602667S thru PZF602734S, PZF602736S thru PZF602774S, PZF602776S thru PZF602875S, PZF602877S thru PZF603020S, PZF603022S thru PZF603122S, PZF603124S thru PZF603271S, PZF603273S thru PZF603329S, PZF603331S, PZF603332S, PZF603333S, PZF603334S, PZF603335S, PZF603336S, PZF603337S, PZF603338S, PZF603339S, PZF603340S, PZF603341S, PZF603342S, PZF603343S, PZF603344S, PZF603346S thru PZF603439S, PZF603441S thru PZF603477S, PZF603479S thru PZF603494S, PZF603496S thru PZF603576S, PZF603578S thru PZF603755S, PZF603757S thru PZF603940S, PZF603942S, PZF603943S, PZF603944S, PZF603945S, PZF603946S, PZF603947S, PZF603948S, PZF603950S thru PZF604161S, PZF604163S thru PZF604186S, PZF604188S, PZF604189S, PZF604190S, PZF604191S, PZF604192S, PZF604194S thru PZF604572S, PZF604574S thru PZF604841S, PZF604843S thru PZF604949S, PZF604951S thru PZF604975S, PZF604977S thru PZF605136S, PZF605138S thru PZF605169S, PZF605171S thru PZF605186S, PZF605188S thru PZF605227S, PZF605229S, PZF605230S, PZF605231S, PZF605232S, PZF605233S, PZF605234S, PZF605235S, PZF605236S, PZF605237S, PZF605238S, PZF605239S, PZF605240S, PZF605241S, PZF605242S, PZF605243S, PZF605245S thru PZF605279S, PZF605281S thru PZF605353S, PZF605355S thru PZF605370S, PZF605372S thru PZF605417S, PZF605419S thru PZF605753S, PZF605755S thru PZF605769S, PZF605771S thru PZF605785S, PZF605787S, PZF605788S, PZF605789S, PZF605790S, PZF605791S, PZF605792S, PZF605793S, PZF605795S thru PZF605844S, PZF605846S thru PZF605957S, PZF605959S thru PZF605982S, PZF605984S thru PZF606035S, PZF606037S thru PZF606135S, PZF606137S thru PZF606224S, PZF606226S thru PZF606273S, PZF606275S, PZF606276S, PZF606277S, PZF606278S, PZF606279S, PZF606280S, PZF606281S, PZF606283S thru PZF606409S, PZF606411S thru PZF606482S, PZF606484S thru PZF606530S, PZF606532S thru PZF606545S, PZF606547S thru PZF606588S, PZF606590S thru PZF606730S, PZF606732S thru PZF606759S, PZF606761S thru PZF606897S, PZF606899S thru PZF606915S, PZF606917S thru PZF606940S, PZF606942S, PZF606945S thru PZF606958S, PZF606960S thru PZF606970S, PZF606972S thru PZF607064S, PZF607066S thru PZF607142S, PZF607144S thru PZF607181S, PZF607183S, PZF607185S, PZF607186S, PZF607187S, PZF607188S, PZF607189S, PZF607190S, PZF607191S, PZF607192S, PZF607193S, PZF607194S, PZF607195S, PZF607196S, PZF607197S, PZF607198S, PZF607199S, PZF607200S, PZF607202S thru PZF607305S, PZF607307S, PZF607309S thru PZF607389S, PZF607391S thru PZF607401S, PZF607403S thru PZF607419S, PZF607421S thru PZF607441S, PZF607443Sthru PZF607515S, PZF607517S thru PZF607551S, PZF607553S thru PZF607612S, PZF607614S thru PZF607663S, PZF607665S thru PZF607697S, PZF607699S, PZF607700S, PZF607701S, PZF607702S, PZF607703S, PZF607704S, PZF607706S thru PZF607782S, PZF607784S thru PZF607998S, PZF608000S thru PZF608039S, PZF608041S thru PZF608095S, PZF608097S thru PZF608142S, PZF608144S, PZF608145S, PZF608146
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
763-514-4000
For Additional Information Contact
763-514-4000
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 20974
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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