Boston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk
Boston Scientific is recalling approximately 16,750 Emblem S-ICD devices because they may deliver atypical energy levels due to internal memory corruption.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a significant injury risk (atypical energy delivery in a life-saving cardiac device) corresponds to a severity score of 4 (Severe).
Plain-English summary
Boston Scientific Corporation is recalling approximately 16,750 Emblem S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillators. These prescription devices are 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.
The recall is being conducted because the devices can deliver an atypical amount of energy due to memory corruption inside the device. This defect poses a risk of inappropriate therapy delivery to patients.
The affected devices were distributed nationwide in the United States, including Puerto Rico, the U.S. Virgin Islands, and Guam, as well as in foreign countries including Canada. All serial numbers are included in this recall. Patients with these devices should contact their healthcare provider or Boston Scientific for further instructions regarding the recall and potential replacement or repair options.
The recalled product
- Product
- 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…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Implant
- Affected units
- 16,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Similar recalls
- HighBoston Scientific Recalls 28 Subcutaneous Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-09-25
- HighBoston Scientific Recalls S-ICD Devices Due to Battery Depletion
FDA (Devices) · 2019-09-25
- CriticalBoston Scientific Recalls Emblem S-ICD Subcutaneous Electrodes Due to Fracture Risk
FDA (Devices) · 2021-01-27
- HighBoston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error
FDA (Devices) · 2022-11-09
- SevereBoston Scientific Recalls SQ-RX Pulse Generators for Battery Malfunctions
FDA (Devices) · 2018-11-28
- HighEMBLEM S-ICD Pulse Generator May Lose Heart Sensing for 24 Hours
FDA (Devices) · 2023-08-30