EMBLEM™ MRI S-ICD A219Recalls & reported problems

Summary

The FDA's MAUDE database contains 15,404 adverse event reports that list this exact device (DI 00802526584404), received between Jan 19, 2017 and Sep 30, 2026 — classified as 36 deaths, 11,052 injuries, 4,316 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (6,166 reports).

2 FDA recall records name this device's identifier, 2 still open.

9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 11, 2023Class IIOpen, 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-2442-2023 · Root cause: Software design · Recall details · FDA record ↗

2. Sep 30, 2022Class IIOpen, Classified

   There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

   Z-0152-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 15,404 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 50951305 ↗
• InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) delivered four inappropriate shocks due to suspected supraventricular tachycardia (SVT). Technical Services (TS) recommended the field representative review with the physician to declare the rhythm. This occurred in Secondary vector. The SVT was around 200 beats per minute (BPM) and the rate slowed below the rate cutoff (RCO) on the fourth shock. However, the rhythm persisted. This S-ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50951029 ↗
• InjurySep 30, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that the patient had an inappropriate shock. The patient was doing Pilates at the time of the shock. The patient has lost a significant amount of weight since the implant back in 2022. An office device check found low intrinsic amplitudes. The sensing vector was then programmed to a new sensing vector. Later, the patient wanted the system explanted due to an improvement in the ejection fraction. The doctor explanted the entire system. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50949202 ↗
• InjurySep 30, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that the patient had inappropriate shocks due to t-wave oversensing via reduced intrinsic complexes. The Smart Pass feature had programmed itself off due to the low intrinsic amplitudes. The sensing vector was programmed to the primary vector. Office testing found the sensing was poor in all three of the sensing vectors. The xrays were done and are unchanged from implant. The electrode is a bit left of the sternum to avoid the sternal wires. Technical Services advised some testing options. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50948567 ↗
• 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 50947145 ↗
• MalfunctionSep 30, 2026Defibrillation/Stimulation Problem; Under-Sensing

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) exhibited a delay in shock therapy due to functional undersensing. Early in the patient's ventricular arrythmia episode, there were large, polymorphic ventricular tachycardia (VT) and ventricular fibrillation (VF) amplitudes that slowed the device's ability to increase its sensitivity. Then, this S-ICD sensed the VF and provided appropriate shock therapy. Technical Services (TS) suspected therapy was delayed by two to three seconds. TS discussed a vector change would not resolve this issue. Also, the patient reported syncope during this episode. This S-ICD remains in service. No adverse patient effects were reported.

  Patient problems: Syncope/Fainting

  MAUDE report 50946690 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate or Unexpected Reset; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946053 ↗
• 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 50945818 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50939238 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) system delivered seven shocks as inappropriate therapy due to oversensing of noisy signals. Technical Services (TS) was consulted and reviewed stored data. TS discussed stored data as well as device programming options. TS discussed troubleshooting options, with further examination recommended. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50938040 ↗
• MalfunctionSep 29, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

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

  MAUDE report 50937380 ↗
• MalfunctionSep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient had an inappropriate shock due to a supraventricular tachycardia. The sensing vector was programmed to the secondary vector. The shock terminated the rhythm. Technical Services discussed the electrograms with the caller. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50935179 ↗
• MalfunctionSep 29, 2026Data Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934526 ↗
• 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: Shock from Patient Lead(s)

  MAUDE report 50934191 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Use of Device Problem

  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 50931860 ↗
• MalfunctionSep 28, 2026Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Read Input Signal; Device Sensing Problem; Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926225 ↗
• InjurySep 28, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Under-Sensing

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50924612 ↗
• MalfunctionSep 28, 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 S-ICD remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50923171 ↗
• MalfunctionSep 28, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50921320 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50918235 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918063 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50917230 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) exhibited a BD (battery depletion) message, which indicates possible premature battery depletion. A request was made to have data from this device analyzed. Data analysis confirmed that BD message was a false positive and occurred due to frequent and extended magnet application. Technical Services (TS) discussed the patient didn't need to be brought in to reset the beeper and discussed where to navigate to silence tones. This S-ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914815 ↗
• MalfunctionSep 28, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient had an inappropriate shock due to the oversensing of noise. The patent was asleep at the time of the shock. The sensing vector was programmed to the primary vector. Technical Services discussed some testing to do for myopotential noise. The clinic reprogrammed the sensing vector to the secondary vector. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50913557 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) was part of the system revision due to infection. No adverse patient effects were reported. The S-ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50911127 ↗

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-2441-2023 · Jul 11, 2023 · Open, Classified
  EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
• 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-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-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-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