The SQ-RX Pulse Generator a component of the Subcutaneous Implantable… — Class II medical device recall Z-0474-2019
Terminated recall by Boston Scientific Corporation, reported 2018-11-28, distributed nationwide. Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery
| Recall number | Z-0474-2019 |
|---|---|
| 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 | 2018-11-01 |
| Classified | 2018-11-16 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2019-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 12,900 |
| Reason classes | device malfunction |
| Model numbers | 1010 |
Product
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System 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
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
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-0474-2019. 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.