Subcutaneous Implantable Cardioverter Defibrillator — Class II medical device recall Z-2542-2019
Ongoing recall by Boston Scientific Corporation, reported 2019-09-25, distributed nationwide. Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier th
| Recall number | Z-2542-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2019-08-21 |
| Classified | 2019-09-13 |
| Reported by FDA | 2019-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LT, LU, LV, MX, MY, NL, NO, NZ, OM, PL, PT, QA, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, ZA |
| Quantity | 28 devices |
| Model numbers | A209 |
Product
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Reason for recall
Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated 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-2542-2019. 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.