EMBLEM S-ICD Pulse Generator May Lose Heart Sensing for 24 Hours
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for temporary loss of critical sensing function. Risk-of-harm product where serious harm—inability to respond to life-threatening arrhythmias—is theoretically possible during a 24-hour sensing disablement window.
Plain-English summary
Boston Scientific Corporation is recalling 3,856 units of the EMBLEM S-ICD Pulse Generator Model A209, a subcutaneous implantable cardioverter defibrillator, worldwide. The S-ICD is an implanted device that monitors the heart's electrical activity and delivers therapy to correct dangerous heart rhythms.
A rare interaction between the S-ICD and the LATITUDE communicator device may cause the S-ICD's sensing function to become disabled for a 24-hour period. During this time, the device would be unable to detect and respond to dangerous heart rhythms that require treatment.
Patients with affected devices should contact their healthcare provider or Boston Scientific for guidance and management of this issue. Affected devices can be identified through specific product codes and LATITUDE system enrollment records.
The recalled product
- Product
- EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 3,856
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 (14)
- GTIN: 00802526544101
- 00802526548406
- 00802526575105
- 00802526575112
- 00802526575129
- 00802526575136
- 00802526575143
- 00802526575167
- 00802526575181
- 00802526575204
- 00802526575211
- 00802526575228
- 00802526599002
- All EMBLEM S-ICDs enrolled in LATITUDE
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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 2 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
- SevereBoston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk
FDA (Devices) · 2017-08-23
- HighBoston Scientific Recalls Emblem S-ICD Pulse Generators Due to Battery Depletion
FDA (Devices) · 2021-02-03
- HighBoston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error
FDA (Devices) · 2022-11-09
- HighBoston Scientific Recalls Emblem MRI S-ICD Pulse Generators Due to Battery Depletion
FDA (Devices) · 2021-02-03