EMBLEM S-ICDRecalls & reported problems across all models

We found 4 models of EMBLEM S-ICD by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 13,295 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2015 and Sep 30, 2026 — classified as 20 deaths, 10,455 injuries, 2,820 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (5,131 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EMBLEM S-ICD recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 11, 2023Open, Classified

   There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

   Z-2441-2023 · Root cause: Software design · Recall details · FDA record ↗

Most reported EMBLEM S-ICD problems

EMBLEM S-ICD models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EMBLEM™ S-ICD A209

  Implantable cardioverter defibrillator (non-CRT)
  1 recall7 deaths6,788 reports
• EMBLEM™ S-ICD 3501

  Implantable cardioverter defibrillator (non-CRT)
  7 deaths4,936 reports
• EMBLEM™ S-ICD 3401

  Implantable cardioverter defibrillator (non-CRT)
  5 deaths1,039 reports
• EMBLEM™ S-ICD 3401

  Implantable cardioverter defibrillator (non-CRT)
  1 death532 reports

Recent EMBLEM S-ICD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50951308 ↗
• InjurySep 30, 2026Impedance Problem

  It was reported that the low energy shock impedance was high. The doctor elected to explant and replace the entire system. This was done successfully. There were no additional adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949520 ↗
• MalfunctionSep 30, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) system delivered an inappropriate shock due to oversensing of noise. The patient reported feeling dizzy before the shock episode. It was noted the patient has a left ventricular assist device (LVAD). Technical Services (TS) reviewed device data and suspected the noise was non-physiological. TS recommended troubleshooting options. The field representative confirmed no noise was reproducible with xyphoid palpitations, pocket manipulation, or isometrics. TS suspected Sense B noise. TS discussed due to the LVAD, Secondary vector wasn't an option. TS recommended other reprogramming options or replacing the entire system. However, TS discussed that Sense B could occur again on a new system. The field representative stated they would discuss the options with electrophysiology (EP). It was noted the patient was also on the transplant list. Currently, this electrode remains in service. No adverse patient effects were reported.

  Patient problems: Dizziness; Shock from Patient Lead(s)

  MAUDE report 50946999 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that the patient had an inappropriate shock due to the oversensing of noise via reduced intrinsic amplitudes. The patent was in a recliner holding his grandchild at the time of the shock. The patient has lost about forty pounds in the past year. The sensing vector was programmed to the alternate vector. Technical Services discussed some programming options. The clinic has now reprogrammed the sensing vector to the primary vector. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50946061 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that the patient had an inappropriate shock due to the oversensing of noise via decrease intrinsic amplitudes. The device sensing vector was then reprogrammed from the primary vector to the alternate vector. Later, there were some untreated episodes due to the same oversensing of noise and low amplitudes. The Smart Pass feature programmed itself off due to low amplitudes. The local representative will discuss some options with the clinic. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50946059 ↗
• InjurySep 30, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that the patient had inappropriate shocks due to oversensing of noise via reduced intrinsic complexes. The patient has a pacemaker. There were inappropriate shocks in both the primary and alternate sensing vectors. There has been a total of four inappropriate shocks. Technical Services advised some programming options. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50946058 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50946056 ↗
• InjurySep 30, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that the patient had an additional inappropriate shock due to t-wave oversensing via wide intrinsic complexes. The sensing vector was set to the alternate vector. The office testing found poor sensing in all three of the sensing vectors. The doctor elected to program the therapy off and sent the patient home with a life vest. The plan is to explant and replace the system with a transvenous system. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50946052 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Material Integrity Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50939926 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this patient received two inappropriate shocks from this subcutaneous implantable cardioverter defibrillator (SICD). Boston Scientific (BSC) Technical Services (TS) was contacted for episode review. TS inquired as to what vector the device was programmed to and this information was unknown. The Consultant stated the presentation appears to be similar to devices programmed to secondary vector that have a seal plug issue and recommended reprogramming from secondary vector to primary vector. However, if it is discovered that primary was the programmed vector, then this could indicate air at the sensing electrode and the vector should be reprogrammed to secondary. The BSC local area representative will investigate further and program to the vector opposite of what the current programming is. The system remains in service and no additional adverse patient effects were reported. Additional information was received that this device was explanted and returned over five years after the initial clinical observations were reported. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934655 ↗
• InjurySep 29, 2026Impedance Problem

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) system exhibited high out of range system impedance measurements greater than 400 Ohms. It was also observed the device was beeping. Technical Services (TS) was contacted and recommended in clinic follow up because the patient was considered unprotected. This electrode remains in service. No adverse patient effects were reported.Additional information received detailed that this S-ICD system was explanted and successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933392 ↗
• MalfunctionSep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this subcutaneous implantable cardioverter defibrillator (S-ICD) system claimed to receive a shock from the device due to a bug in the Boston Scientific system. The patient claimed Boston Scientific was supposed to alert the hospital that the patient was shocked, but the protocol was not followed. Technical Services (TS) referred the patient to their clinic to discuss device function and education. This electrode remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50933156 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) system delivered an inappropriate shock due to oversensing of noise. Technical Services (TS) reviewed device data and suspected the noise was caused by myopotentials or electromagnetic interference (EMI). TS discussed troubleshooting options, including isometrics testing and programming to another vector. This S-ICD system was in Secondary vector during the shock episode. This electrode remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50933143 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50918406 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50917281 ↗

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