Recall Z-0828-06 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Guidant Corporation
Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and
| Date | May 2, 2006 (initiated Apr 7, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 20 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.