FDA Device recall Z-3039-2017
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-thr…
- FDA Device
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-thr… 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-3039-2017 |
| 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
SQ-RX 1010 Pulse Generator, 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-3039-2017%22
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