Boston Scientific COGNIS CRT-D — Class II medical device recall Z-0025-2014
Terminated recall by Boston Scientific CRM Corp, reported 2013-10-23, distributed nationwide. The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to
| Recall number | Z-0025-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific CRM Corp, Saint Paul, MN, United States |
| Recall initiated | 2013-08-29 |
| Classified | 2013-10-17 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, AW, BE, BM, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, HU, IE, IL, IR, IT, JO, JP, KR, KW, LB, LV, MX, MY, NL, NO, NZ, PA, PE, PL, PT, SA, SE, SG, SI, SK, SV, TH, TT, TW, VE, ZA |
| Quantity | 38,500 worldwide |
| Serial numbers | 000036, 000085, 000087, 000088, 000090, 000091, 000093, 000094, 000096, 000097, 000098, 000103, 000106, 000107, 000112, 000114, 000115, 000117, 000119, 000120, 000121, 000125, 000128, 000132, 000133 and 475 more |
| Model numbers | N106, N107, N118, N119, P106, P107 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0025-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.