FDA Device recall Z-3038-2017
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide…
- FDA Device
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide… by Boston Scientific, citing the device can deliver an atypical amount of energy due to memory corruption inside the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3038-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-29 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
Reason
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Identifiers
| code_info | All serial numbers |
|---|
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-3038-2017%22
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