Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). 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.
This recall has been terminated (originally issued May 2, 2006).
- Company
- Guidant Corporation
- Recall Initiated
- April 7, 2006
- Posted
- May 2, 2006
- Terminated
- April 1, 2007
- Recall Number
- Z-0826-06
- Quantity
- 20 devices
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
model H190 serial numbers: 311739, 311740, 311742, 311743, 311744, 311745, 311747, 311748, 311751, 311769, 311811, 311834, 311850, 311852, 311853, 311884, 311895, 311900, . model H195 serial number: 353166. model H197 serial number: 310331.
Root Cause
Other
Action Taken
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.