FDA Device recall Z-0025-2014
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119
- FDA Device
- Class II
- terminated
- Published 2013-10-23
On 2013-10-23 the FDA classified a Class II recall of Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119 by Boston Scientific Crm, citing 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 curre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0025-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-29 |
| Published | 2013-10-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific Crm |
| Distribution | US |
Product
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. 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.
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.
Identifiers
| code_info | Model N118, Serial numbers: 559191, 559192, 559195, 559196, 559200, 559201, 559202, 559203, 559210, 559211, 559212, 55…Model N118, Serial numbers: 559191, 559192, 559195, 559196, 559200, 559201, 559202, 559203, 559210, 559211, 559212, 559215, 559222, 559223, 559225, 559226, 559231, 559232, 559236, 559238, 559239, 559240, 559241, 559242, 559245, 559247, 559250, 559251, 559253, 559257, 559260, 559262, 559263, 559266, 559267, 559272, 559273, 559275, 559277, 559278, 559279, 559281, 559282, 559283, 559286, 559289, 559292, 559294, 559298, 559300, 559301, 559303, 559306, 559307, 559314, 559317, 559318, 559319, 559321, 559322, 559324, 559325, 559327, 559330, 559334, 559336, 559338, 559339, 559340, 559341, 559342, 559343, 559344, 559349, 559350, 559353, 559355, 559359, 559361, 559368, 559372, 559373, 559374, 559378, 559379, 559381, 559382, 559384, 559385, 559388, 559389, 559391, 559393, 559394, 559395, 559396, 559397, 559398, 559399, 559400, 559405, 559410, 559412, 559413, 559415, 559416, 559417, 559418, 559419, 559420, 559423, 559426, 559428, 559429, 559431, 559435, 559437, 559438, 559439, 559444, 559446, 559 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0025-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.