Boston Scientific COGNIS CRT-D — Class II medical device recall Z-0087-2015
Terminated recall by Boston Scientific CRM Corp, reported 2014-10-29, distributed nationwide. Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased
| Recall number | Z-0087-2015 |
|---|---|
| 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 | 2014-09-17 |
| Classified | 2014-10-17 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-02-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BB, BE, BM, BR, BS, CA, CH, CL, CO, CR, CY, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, HK, HN, HT, HU, ID, IE, IL, IN, IR, IT, JM, JO, JP, KR, KW, KY, LB, LK, LU, LV, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, ZA |
| Quantity | 31,144 total |
| Serial numbers | 001589, 001590, 001591, 001592, 001594, 001596, 001597, 001598, 001599, 001600, 001601, 001602, 001603, 001605, 001606, 001607, 001608, 001609, 001610, 001611, 001612, 001613, 001615, 001616, 001617 and 475 more |
| Model numbers | N106, N107, N108, N118, N119, P106, P107, P108 |
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 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
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-0087-2015. 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.