SQ-RX 1010 Pulse Generator — Class II medical device recall Z-3039-2017
Terminated recall by Boston Scientific Corporation, reported 2017-08-23, distributed nationwide. The device can deliver an atypical amount of energy due to memory corruption inside the device.
| Recall number | Z-3039-2017 |
|---|---|
| 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 | 2017-06-29 |
| Classified | 2017-08-15 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2019-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 12,450 devices |
| Serial numbers | 1010 |
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 for recall
The device can deliver an atypical amount of energy due to memory corruption inside the device.
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-3039-2017. 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.