EMBLEM™ S-ICD 3501Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,936 adverse event reports that list this exact device (DI 00802526599200), received between Jan 29, 2018 and Sep 30, 2026 — classified as 7 deaths, 3,660 injuries, 1,269 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (2,747 reports).

11 other recalls cover devices cleared under the same FDA submission (P110042); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 4,936 reports, 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 ↗
• 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, 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 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50911131 ↗
• InjurySep 25, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Malposition of Device

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) system was unable to induce an arrythmia at implant. Imaging was completed, and it appeared the S-ICD system was too superior but was unable to be confirmed by the imaging performed at that time. After being discharged after implant, the patient experienced two inappropriate shocks and presented to the emergency room (ER). In the ER, the patient's device therapy was programmed off. Technical Services (TS) reviewed the two shock episodes. The first shock episode was caused by small amplitudes and oversensing of noisy signals. The second episode was caused by small amplitudes and T-wave oversensing. There was no change in rhythm after shock therapy. TS recommended performing further imaging to confirm system location and determine if a system revision was required. This electrode remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50898179 ↗
• MalfunctionSep 25, 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 electromagnetic interference (EMI). It was noted the noise was caused by the patient's electric toothbrush and the noise ended post shock. Technical Services (TS) provided troubleshooting options. This electrode remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50897303 ↗
• InjurySep 25, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that the patient had an inappropriate shock due to t-wave oversensing via a change in the intrinsic morphology. The sensing vector was programmed to the secondary vector. The Smart Pass feature had programmed itself off due to the low amplitudes. Technical Services discussed the electrograms with the caller. Later, the doctor explanted and replaced the entire system with a transvenous system. There were no additional adverse patient effects.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50896349 ↗
• InjurySep 25, 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 the oversensing of noise. A review of the electrograms for the shock episodes found rail-to-rail noise and reduced amplitudes. There were some stored untreated episodes due to the same railing noise. The sensing vector at the time of the shocks was set to the primary sensing vector. Technical Services advised some options. The sensing vector has now been reprogrammed to the secondary sensing vector. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50896345 ↗
• InjurySep 25, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient had inappropriate shocks due to the oversensing of noise. The patent had a cough and bronchitis a at the time of one of the shocks. The sensing vector was programmed to the primary vector. Also, the high energy shock impedance was 111 ohms, which is high but within normal limits. Technical Services discussed some testing and programming options. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50896269 ↗
• InjurySep 24, 2026Over-Sensing

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) and electrode stored an Untreated Episode that appeared show a true pause. Review of the episode shows signal double-counting was observed at times, with possible agonal rhythm or possible cardiopulmonary resuscitation (CPR) compressions before the pause event. The patient was currently intubated at the hospital. This electrode remains in service. No additional adverse patient effects were reported.

  Patient problems: Asystole

  MAUDE report 50876649 ↗
• MalfunctionSep 23, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50876325 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Subcutaneous Implantable Cardioverter Defibrillator electrode was explanted due to a product advisory. No additional adverse patient effects were reported. A new electrode was successfully implanted. The electrode was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873545 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of a system revision due to infection. There were no additional adverse patient effects reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50873377 ↗
• MalfunctionSep 23, 2026Over-Sensing; Failure to Read Input Signal; Under-Sensing; Migration

  It was reported that the Smart Pass feature on this device had programmed itself off due to low intrinsic amplitudes. This has happened multiple times. The sensing vector is programmed to the secondary vector. Technical Services reviewed the provided x-rays. The electrode has dropped out of position. It was advised to inform the physician. There were no adverse patient effects. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870460 ↗
• MalfunctionSep 21, 2026Use of Device Problem; Material Integrity Problem

  It was reported that this electrode was cut during a heart surgery procedure. The electrode was later replaced with a new one. There were no additional adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840166 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P110042. One submission often covers many models, so check the product and lot details in each record.

• Z-2442-2023 · Jul 11, 2023 · Open, Classified
  EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
• Z-2441-2023 · Jul 11, 2023 · Open, Classified
  EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
• Z-0152-2023 · Sep 30, 2022 · Open, Classified
  EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
• Z-0151-2023 · Sep 30, 2022 · Open, Classified
  EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
• Z-0474-2019 · Nov 1, 2018 · Terminated
  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
• Z-3038-2017 · Jun 29, 2017 · Terminated
  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 trea
• Z-3039-2017 · Jun 29, 2017 · Terminated
  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 i
• Z-3037-2017 · Jun 29, 2017 · Terminated
  EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatmen
• Z-1178-2017 · Jan 12, 2017 · Terminated
  Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
• Z-0232-2016 · Sep 17, 2015 · Terminated
  Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
• Z-0965-2013 · Mar 1, 2013 · Terminated
  Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular t