FDA Device recall Z-0938-2017
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly
- FDA Device
- Class II
- terminated
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0938-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-30 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | IA, NY |
Product
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Reason
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.
Identifiers
| code_info | Model 7740 S/N 633464, 610662. Model 7741 S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742…Model 7740 S/N 633464, 610662. Model 7741 S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742 S/N 572200, 584869, 631202. Model 7732 S/N 488740. Model 7736 S/N 631322, 632188. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0938-2017%22
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