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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 Model D224VRC, serial numbers: PUX200008H thru PUX200046H, PUX200048H, PUX200049H, PUX200050H, PUX200051H, PUX200052H, PUX200053H, PUX200054H, PUX200055H, PUX200057H thru PUX200083H, PUX200085H thru PUX200141H, PUX200143H thruPUX200271H, PUX200273H thru PUX200369H, PUX200371H thru PUX200416H, PUX200418H thru PUX200465H, PUX200467H thru PUX200496H, PUX200498H thru PUX200577H, PUX200579H, PUX200581H, PUX200582H, PUX200583H, PUX200584H, PUX200585H, PUX200586H, PUX200587H, PUX200588H, PUX200589H, PUX200592H thru PUX200666H, PUX200668H thru PUX200731H, PUX200733H thru PUX200945H, PUX200947H thru PUX200962H, PUX200964H thru PUX201029H, PUX201031H thru PUX201054H, PUX201057H thru PUX201086H, PUX201088H thru PUX201101H, PUX201103H thru PUX201136H, PUX201139H, PUX201140H, PUX201141H, PUX201142H, PUX201144H, PUX201145H, PUX201150H, PUX201151H, PUX201152H, PUX201154H thru PUX201192H, PUX201194H thru PUX201344H, PUX201346H thru PUX201382H, PUX201384H thru PUX201626H, PUX201628H, PUX201630H, PUX201631H, PUX201632H, PUX201633H, PUX201634H, PUX201635H, PUX201636H, PUX201637H, PUX201638H, PUX201639H, PUX201640H, PUX201642H thru PUX201666H, PUX201668H, PUX201669H, PUX201670H, PUX201671H, PUX201672H, PUX201673H, PUX201674H, PUX201675H, PUX201676H, PUX201677H, PUX201678H, PUX201680H thru PUX201732H, PUX201734H, PUX201735H, PUX201736H, PUX201737H, PUX201739H, PUX201740H, PUX201742H thru PUX201823H, PUX201825H thru PUX201921H, PUX201923H thru PUX201946H, PUX201948H thru PUX201977H, PUX201979H thru PUX202194H, PUX202196H thru PUX202266H, PUX202268H thru PUX202368H, PUX202370H thru PUX202393H, PUX202395H, PUX202396H, PUX202399H thru PUX202516H, PUX202518H thru PUX202558H, PUX202560H, PUX202561H, PUX202562H, PUX202563H, PUX202564H, PUX202565H, PUX202566H, PUX202567H, PUX202568H, PUX202570H thru PUX202748H, PUX202750H thru PUX202852H, PUX202854H thru PUX202874H, PUX202876H thru PUX202917H, PUX202919H thru PUX203032H, PUX203034H thru PUX203117H, PUX203119H thru PUX203252H, PUX203254H thru PUX203303H, PUX203305H thru PUX203344H, PUX203346H, PUX203347H, PUX203348H, PUX203349H, PUX203350H, PUX203351H, PUX203353H thru PUX203414H, PUX203416H, PUX203417H, PUX203418H, PUX203419H, PUX203420H, PUX203423H, PUX203424H, PUX203425H, PUX203426H, PUX203427H, PUX203428H, PUX203429H, PUX203430H, PUX203431H, PUX203432H, PUX203433H, PUX203434H, PUX203436H, PUX203437H, PUX203438H, PUX203439H, PUX203441H, PUX203442H, PUX203443H, PUX203445H, PUX203446H, PUX203447H, PUX203448H, PUX203449H, PUX203450H, PUX203451H, PUX203452H, PUX203453H, PUX203455H thru PUX203528H, PUX203530H thru PUX203561H, PUX203563H thru PUX203584H, PUX203585H, PUX203586H, PUX203587H, PUX203590H thru PUX203663H, PUX203666H thru PUX203692H, PUX203694H thru PUX203838H, PUX203840H thru PUX203875H, PUX203877H thru PUX204186H, PUX204188H thru PUX204422H, PUX204424H thru PUX204658H, PUX204660H thru PUX204708H, PUX204710H, PUX204712H, PUX204713H, PUX204714H, PUX204715H, PUX204716H, PUX204717H, PUX204718H, PUX204719H, PUX204720H, PUX204721H, PUX204722H, PUX204723H, PUX204724H, PUX204725H, PUX204727H thru PUX204864H, PUX204866H thru PUX205008H, PUX205010H thru PUX205068H, PUX205070H thru PUX205256H, PUX205258H thru PUX205361H, PUX205363H thru PUX205397H, PUX205399H, PUX205400H, PUX205401H, PUX205402H, PUX205403H, PUX205404H, PUX205405H, PUX205406H, PUX205407H, PUX205408H, PUX205410H thru PUX205459H, PUX205461H thru PUX205629H, PUX205631H thru PUX205643H, PUX205645H thru PUX205670H, PUX205672H, PUX205673H, PUX205674H, PUX205675H, PUX205676H, PUX205677H, PUX205678H, PUX205679H, PUX205680H, PUX205681H, PUX205682H, PUX205683H, PUX205685H thru PUX205748H, PUX205750H thru PUX205767H, PUX205769H thru PUX206009H, PUX206011H thru PUX206044H, PUX206046H thru PUX206078H, PUX206080H thru PUX206128H, PUX206130H thru PUX206225H, PUX206227H thru PUX206382H, PUX206384H thru PUX206436H, PUX206438H thru PUX206480H, PUX206482H thru PUX206589H, PUX206591H thru PUX206669H, PUX206671H thru PUX206811H, PUX206813H thru PUX206911H, PUX20
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
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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