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Medical Device Recalls
Class 2 Recall
CONTAK RENEWAL 3
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Date Recall
Initiated |
April 07, 2006
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| Date Posted |
May 02, 2006
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| Recall Number |
Z-0825-06
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| Product |
Guidant 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.
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| 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.
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Recalling Firm/
Manufacturer |
Guidant Corporation
4100 Hamline Ave N
Saint Paul
, Minnesota
55112-5700
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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.
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| Action |
Guidant 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.
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| Quantity in Commerce |
65 devices
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| Distribution |
Nationwide. 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.
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