Boston Scientific SQ-RX 1010 Pulse Generator Recall: Energy Delivery Risk
Boston Scientific recalls SQ-RX 1010 Pulse Generators due to potential memory corruption causing atypical energy delivery. Affected devices may deliver incorrect shock levels during life-threatening heart conditions.
Use caution until it’s fixed
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Contact the company
What happened, in plain English
Boston Scientific is recalling SQ-RX 1010 Pulse Generators that could deliver incorrect shock energy due to memory corruption. This risk could affect patients needing defibrillation therapy for life-threatening heart rhythms. Read more at govinfonow.com/recall/73501-boston-scientific-sq-rx-1010-pulse-generator-recall-energy-delivery.
Source Summary by GovInfoNow · govinfonow.com/recall/73501-boston-scientific-sq-rx-1010-pulse-generator-recall-energy-delivery · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3039-2017
Cite this page
“Boston Scientific SQ-RX 1010 Pulse Generator Recall: Energy Delivery Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73501-boston-scientific-sq-rx-1010-pulse-generator-recall-energy-delivery. Based on FDA recall #Z-3039-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3039-2017%22&limit=1).
Why it’s dangerous
The device's memory can become corrupted, causing it to deliver an atypical amount of energy during shock therapy. This could lead to incorrect shock delivery when treating life-threatening heart rhythms, potentially causing harm to the patient.
Who’s affected
Patients with S-ICD systems for life-threatening ventricular tachyarrhythmias who own the recalled SQ-RX 1010 Pulse Generators are affected. Those with the device installed and needing regular defibrillation therapy face the highest risk.
How to tell if you have this one
Check for the SQ-RX 1010 Pulse Generator model with the S-ICD system for life-threatening ventricular tachyarrhythmias. All serial numbers are affected as per the recall notice.
- Brand
Boston Scientific- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3037-2017 | EMBLEM S-ICD, Model A209, 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.; All serial numbers | Approximately 16,750 devices |
| Z-3038-2017 | 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; All serial numbers | Approximately 9,200 devices |
| 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-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; All serial numbers | Approximately 12,450 devices |
What to do — step by step
Check Device Status
Verify if your device has the S-ICD system for life-threatening ventricular tachyarrhythmias and the SQ-RX 1010 Pulse Generator model.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3039-2017 (June 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3039-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.