FDA Device recall Z-0087-2015
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119
- FDA Device
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 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 boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0087-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-17 |
| Published | 2014-10-29 |
| 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. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
Reason
Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt
Identifiers
| code_info | Model N106 - Serial numbers: 222276, 222277, 222279, 222280, 222282, 222283, 222286, 222289, 222290, 222291, 22229…Model N106 - Serial numbers: 222276, 222277, 222279, 222280, 222282, 222283, 222286, 222289, 222290, 222291, 222292, 222293, 222295, 222311, 222312, 222314, 222315, 222316, 222318, 222320, 222321, 222324, 222325, 222335, 222338, 222340, 222342, 222343, 222346, 222361, 222363, 222366, 222372, 222374, 222409. Model N107 - Serial numbers: 100278, 100279, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100293, 100294, 100295, 100297, 100298, 100299, 100300, 100301, 100303, 100304, 100305, 100306, 100307, 100308, 100309, 100311, 100312, 100314, 100315, 100317, 100318, 100319, 100320, 100321, 100322, 100324, 100325, 100327, 100328, 100329, 100330, 100331, 100333, 100334, 100335, 100336, 100408, 100409, 100410, 100411, 100413, 100414, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100425, 100426, 100427, 100429, 100430, 100431, 100432, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100441, 100442, 100445, 100446, |
|---|
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-0087-2015%22
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