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U.S. Department of Health and Human Services

Class 2 Device Recall CONTAK RENEWAL 3

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 Class 2 Device Recall CONTAK RENEWAL 3see related information
Date Initiated by FirmApril 07, 2006
Date PostedMay 02, 2006
Recall Status1 Terminated 3 on April 01, 2007
Recall NumberZ-0825-06
Recall Event ID 35166
PMA NumberP010012 
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
ProductGuidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.
Code Information model H170 serial numbers: 364406, 364446, 364542, 364576, 364582, 364586, 364587, 364590, 364591, 364593, 364595, 364596, 364597, 364599, 364600, 364601, 364602, 364604, 364605, 364606, 364607, 364608, 364609, 364611, 364613, 364615, 364623, 364625, 364632, 364633, 364634, 364636, 364643, 364680, 364732, 364735, 364752.  model H175 serial numbers: 315437, 315438, 315452, 315454, 315455, 315456, 315461, 315462, 315464, 315470, 315473, 315480, 315482, 315489, 315496, 315497, 315500, 315580, 315588, 315605.   model H177 serial number: 285055  model H179 serial numbers: 114267, 114268, 114269,  114270, 114271, 114280, 114470.   
Recalling Firm/
Manufacturer
Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
Manufacturer Reason
for Recall
77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.
FDA Determined
Cause 2
Other
ActionGuidant Sales Representatives are retrieving non-implanted devices April 10-12, 2006. If a device is implanted the physician is sent an Urgent Medical Device Safety Information & Corrective Action letter, April 11-14, 2006. This letter describes the issue, states that Guidant is retrieving all non-implanted devices and that Guidant is currently conducting tests on retrieved devices. Physicians will be advised once more information is available.
Quantity in Commerce65 devices
DistributionNationwide. AZ, FL, GA, IL, IN, KY, MA, ME, MI, MN, NC, NE, NY, OH, PA, TN, TX, UT, VA, WI. OUS to include: Australia, Canada, Germany, Italy, Netherlands, Portugal, Slovenia, Spain.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = NIK
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