Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N11...
FDA Device Recall #Z-0087-2015 — Class II — September 17, 2014
Recall Summary
| Recall Number | Z-0087-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 17, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific CRM Corp |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 31,144 total |
Product Description
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 for Recall
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
Distribution Pattern
Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
Lot / Code Information
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, 100447, 100448, 100449, 100450, 100451, 100453, 100454, 100455, 100456, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100482, 100483, 100484, 100485, 100486, 100488, 100489, 100492, 100494, 100495, 100496, 100497, 100498, 100499, 100500, 100501, 100503, 100505, 100506, 100507, 100509, 100518, 100525, 100527, 100531, 100534, 100535, 100536, 100538, 100539, 100540, 100541, 100542, 100543, 100544, 100546, 100547, 100548, 100549, 100550, 100551, 100554, 100555, 100556, 100557, 100558, 100559, 100562, 100563, 100564, 100565, 100566, 100567, 100854, 100855, 100856, 100857, 100858, 100860, 100862, 100863, 100864, 100865, 100866, 100867, 100868, 100869, 100870, 100871, 100872, 100873. Model N108 - Serial numbers: 666667, 666668, 666669, 666670, 666671, 666672, 666673, 666675, 666676, 666677, 666678, 666679, 666680, 666681, 666682, 666683, 666684, 666685, 666686, 666687, 666688, 666689, 666690, 666691, 666693, 666694, 666695, 666696, 666697, 666699, 666700, 666702, 666703, 666704, 666705, 666706, 666707, 666708, 666710, 666711, 666713, 666714, 666715, 666716, 666717, 666718, 666719, 666720, 666721. Model N118 - Serial numbers: , 565136, 565138, 565140, 565146, 565149, 565151, 565152, 565154, 565155, 565157, 565158, 565160, 565163, 565164, 565165, 565167, 565168, 565170, 565173, 565176, 565177, 565178, 565179, 565181, 565182, 565186, 565187, 565188, 565189, 565190, 565191, 565192, 565193, 565194, 565197, 565198, 565199, 565200, 565202, 565204, 565209, 565210, 565319, 565320, 565321, 565326, 565328, 565329, 565330, 565331, 565332, 565334, 565335, 565336, 565337, 565338, 565339, 565342, 565343, 565344, 565345, 565356, 565359, 565363, 565364, 565365, 565367, 565368, 565371, 565374, 565375, 565376, 565378, 565379, 565383, 565384, 565386, 565388, 565390, 565394, 565396, 565397, 565398, 565401, 565402, 565404, 565406, 565407, 565408, 565409, 565410, 565412, 565415, 565416, 565418, 565421, 565427, 565429, 565433, 565434, 565437, 565440, 565441, 565442, 565444, 565446, 565447, 565448, 565449, 565450, 565452, 565454, 565455, 565457, 565460, 565467, 565469, 565471, 565475, 565476, 565478, 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Model N119 - Serial numbers: 048289, 048292, 048294, 048295, 048296, 048297, 048298, 048299, 048300, 048302, 048303, 048304, 048306, 048307, 048308, 048309, 048310, 048311, 048312, 048313, 048314, 048315, 048318, 048319, 048323, 048325, 048326, 048330, 048332, 048336, 048337, 048338, 048341, 048344, 048408, 048410, 048412, 048413, 048414, 048415, 048416, 048418, 048419, 048420, 048422, 048423, 048425, 048426, 048428, 048430, 048434, 048436, 048440, 048442, 048444, 048447, 048534, 048535, 048537, 048538, 048539, 048540, 048541, 048542, 048543, 048545, 048546, 048547, 048548, 048550, 048551, 048552, 048553, 048554, 048555, 048558, 048560, 048561, 048563, 048564, 048565, 048567, 048570, 048571, 048673, 048676, 048679, 048680, 048681, 048686, 048689, 048691, 048693, 048695, 048698, 048699, 048700, 048701, 048704, 048705, 048707, 048708, 048709, 048710, 048711, 048712, 048713, 048715, 048716, 048720, 048724, 048725, 048726, 048793, 048794, 048812, 048815, 048817, 048818, 048819, 048820, 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Other Recalls from Boston Scientific CRM Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0088-2015 | Class II | Boston Scientific TELIGEN, Implantable Cardiac ... | Sep 17, 2014 |
| Z-2147-2014 | Class II | Boston Scientific ENDOTAK RELIANCE¿ SG, transve... | Jun 19, 2014 |
| Z-0026-2014 | Class II | Boston Scientific TELIGEN, Implantable Cardiac ... | Aug 29, 2013 |
| Z-0025-2014 | Class II | Boston Scientific COGNIS CRT-D, Cardiac Resynch... | Aug 29, 2013 |
| Z-1979-2013 | Class II | Boston Scientific, ENERGEN DR ICD, Model E143. ... | Jul 15, 2013 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.