Boston Scientific TELIGEN — Class II medical device recall Z-0088-2015
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-0088-2015 |
|---|---|
| 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 devices |
| Serial numbers | 000093, 000094, 000095, 000096, 000097, 000098, 000099, 000100, 000101, 000102, 000104, 000105, 000106, 000107, 000108, 000109, 000110, 000111, 000112, 000113, 000114, 000116, 000117, 000118, 000119 and 475 more |
| Model numbers | E102, E103, E110, E111, F102, F103, F110, F111 |
Product
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
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-0088-2015. 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.