Boston Scientific — Class II medical device recall Z-1178-2017
Terminated recall by Boston Scientific Corporation, reported 2017-02-15, distributed nationwide. There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer,
| Recall number | Z-1178-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2017-01-12 |
| Classified | 2017-02-09 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2018-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BM, BR, CA, CH, CN, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IR, IT, JO, JP, KW, LB, LT, LU, LV, MY, NL, NO, NZ, PL, PT, QA, SA, SE, SG, SK, TH, TN, TR, ZA |
| Quantity | 4,500 |
| Model numbers | 3200 |
Product
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Reason for recall
There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.
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-1178-2017. 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.