Recall Z-0026-2014 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific CRM Corp
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
| Date | Oct 17, 2013 (initiated Aug 29, 2013) |
| Status | Terminated |
| Reason | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion. |
| Root cause | Component design/selection |
| Action | An Important Medical Device Information letter dated August 2013 was sent to implanting and following physicians. The letter provided a description of the issue, describes clinical implications, provides the rate of occurrence, and gives recommendations for monitoring patients. |
| Quantity | 38,500 total worldwide |
| Distribution | Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Gr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.