Boston Scientific — Class II medical device recall Z-0938-2017
Terminated recall by Boston Scientific Corporation, reported 2017-01-11, distributed in IA, NY. Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is
| Recall number | Z-0938-2017 |
|---|---|
| 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 | 2016-11-30 |
| Classified | 2016-12-30 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2017-12-13 |
| Distributed | IA, NY |
| Countries outside the US | BE, DE, GB, IT, NL |
| Model numbers | 488740, 563539, 572200, 584869, 610662, 628198, 631202, 631322, 632188, 633464, 636545, 641593, 656713, 656904, 657588, 7732, 7736, 7740, 7741, 7742 |
Product
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Reason for recall
Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.
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-0938-2017. 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.