Recall Z-1249-2012 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic EnTrust, Single Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153VRC and D154VRC. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Medtronic, Inc., Minneapolis, MN 5
| Date | Mar 22, 2012 (initiated Mar 6, 2012) |
| Status | Terminated |
| Reason | A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage. |
| Root cause | Device Design |
| Action | An "Urgent Medical Device Correction" letter was sent to physicians beginning 3/6/2012. The letter described the issue and provided patient management recommendations. Additionally the letter stated that ongoing updates to the product performance report will be posted on a Medtronic website. |
| Quantity | 68,804 devices worldwide |
| Distribution | Worldwide Distribution -- USA, and the countries of: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.