EMBLEM™ S-ICD 3401 (UDI 00802526575600)Recalls & reported problems

Summary

The FDA's MAUDE database contains 532 adverse event reports that list this exact device (DI 00802526575600), received between Apr 28, 2016 and Sep 30, 2026 — classified as 1 death, 427 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (188 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 532 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

  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 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50915452 ↗
• 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 via reduced intrinsic complexes. The Smart Pass feature had programmed itself off due to the low intrinsic amplitudes. The sensing vector was set to the primary vector. There were untreated episodes stored due to the same noise. The doctor ordered some imaging which confirmed there is no suture near sense B electrode. The clinic reprogrammed the sensing vector to the secondary vector. The patient had another inappropriate shock. Technical Services advised some options. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50896262 ↗
• MalfunctionSep 17, 2026Impedance Problem

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) exhibited high out of range system impedance measurements. Technical Services (TS) was consulted and reviewed stored data. TS recommended further in clinic examination, with a revision possibly required. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802552 ↗
• MalfunctionSep 15, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50778851 ↗
• MalfunctionAug 17, 2026High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50284733 ↗
• InjuryAug 14, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient had an inappropriate shock three days post implant due to oversensing of noise. The patient was working underneath the sink when the shock occurred. The sensing vector was set to the secondary vector. The patient also has a pacemaker implanted. The patient had a previous inappropriate shock due to the oversensing of fast pacing. Technical Services discussed options with the caller. The clinic elected not to reprogram the device. The system remains implanted. There were no additional adverse patient effects.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50255902 ↗
• MalfunctionAug 6, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50151046 ↗
• InjuryJul 28, 2026High impedance; Failure to Read Input Signal; Unexpected Therapeutic Results; Under-Sensing

  It was reported that the patient with this subcutaneous implantable cardioverter defibrillator (S-ICD) system received therapy for a ventricular arrhythmia that required two shocks for successful conversion. Review of the episode noted that the first shock was unsuccessful and undersensing of the low-amplitude ventricular fibrillation (VF) resulted in delayed detection. Shock impedance during the episode was 114 ohms, while measured system impedance was 75 ohms; this difference is considered expected due to normal variations. The device was programmed to the Secondary sensing vector and Smart Pass enabled. The device remains in service. No adverse patient effects were reported.Additional information obtained, this subcutaneous implantable cardioverter defibrillator (S-ICD) system has been explanted and replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50056041 ↗
• MalfunctionJul 20, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) system delivered an inappropriate shock due to oversensing of muscle noise. The patient was having intercourse at the time of the episode. Smart Pass was on and Secondary vector was programmed. The health care professional (HCP) determined Alternate vector had a low amplitude and was not viable. Technical Services (TS) recommended reprogramming to Primary vector and maxing out Smart Charge. TS discussed options for testing Primary vector in clinic. This electrode remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25883990 ↗
• InjuryJun 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT RECENTLY, THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS UNABLE TO BE INTERROGATED, AND BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR REVIEW. IT WAS DISCUSSED THAT THE DEVICE'S TACHYCARDIA THERAPY HAD BEEN DISABLED IN (B)(6) 2022 DUE TO OVER-SENSED NOISE (EITHER MYOPOTENTIAL OR ELECTROMAGNETIC INTERFERENCE IN ORIGIN) LEADING TO INAPPROPRIATE THERAPY. AT THE TIME, THE DEVICE BATTERY CAPACITY WAS AT 40%, AND TS STATED THAT THE INABILITY TO ESTABLISH A REMOTE CONNECTION DUE TO LOW BATTERY WAS POSSIBLE. HOWEVER, DATA WAS NOT PROVIDED FOR ANALYSIS. CURRENTLY, THE S-ICD SYSTEM REMAINS IMPLANTED WITH THERAPY DISABLED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25661962 ↗
• InjuryJun 27, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE DELIVERED INAPPROPRIATE SHOCKS DUE TO DOUBLE- AND TRIPLE-COUNTING. SURFACE ECHOCARDIOGRAM (S-ECG) REVIEW OF ONE TREATED EPISODE HAD SHOWED P-WAVE OVERSENSING, AND THE MORPHOLOGY DID NOT CHANGE POST-SHOCK. IT WAS NOTED THAT THIS S-ICD WAS PROGRAMMED TO SECONDARY, 1X GAIN, AND THE R-WAVES WERE WIDE AND BIPHASIC IN THE PRESENTING/CAPTURED S-ECG. IN PRIMARY AND ALTERNATE, THE R-WAVES WERE NARROW. TECHNICAL SERVICES (TS) RECOMMENDED CONSIDERING PRIMARY. THIS ELECTRODE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25644747 ↗
• InjuryJun 26, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS ELECTRODE PRESENTED TO THE CLINIC AFTER RECEIVING AN INAPPROPRIATE SHOCK. A TREADMILL TEST DEMONSTRATED T-WAVE OVERSENSING IN ALL SENSING VECTORS. BASED ON THESE FINDINGS, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR REMOVAL OF THE S-ICD SYSTEM AND REPLACEMENT WITH A BIOTRONIK SINGLE-CHAMBER TRANSVENOUS ICD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25638474 ↗
• MalfunctionJun 22, 2026Off-Label Use; Material Integrity Problem

  IT WAS REPORTED THAT THIS ELECTRODE HAD A SMALL SLIT ON ITS INSULATION THAT WAS REPAIRED USING A REPAIR KIT. THIS ELECTRODE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580106 ↗
• MalfunctionJun 19, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED AN INAPPROPRIATE SHOCK DUE TO T-WAVE OVERSENSING (TWOS). CLINIC EVALUATION SHOWED AUTO SETUP FAILED IN ALL VECTORS AT SECONDARY 1X GAIN, SO ALL SENSING VECTORS WERE ASSESSED AND THE DEVICE WAS REPROGRAMMED TO PRIMARY 2X GAIN. THE ELECTRODE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25563871 ↗
• InjuryJun 15, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD INAPPROPRIATE SHOCKS DUE TO THE OVERSENSING OF NOISE. THERE WAS A STORED UNTREATED EVENT DO TO THE SAME NOISE. THE PATIENT WAS PLAYING TENNIS AT THE TIME OF THE SHOCKS. FOR THE FIRST SHOCK, THE SENSING VECTOR WAS PROGRAMMED TO THE SECONDARY SENSING VECTOR. THE CLINIC REPROGRAMMED THE SENSING VECTOR TO THE PRIMARY VECTOR. LATER, THE PATIENT HAD ANOTHER INAPPROPRIATE SHOCK WHILE PLAYING TENNIS. 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 25508424 ↗
• MalfunctionMay 5, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED ONE SHOCK AS INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS DEVICE PROGRAMMED SETTINGS. TS DISCUSSED PROGRAMMING OPTIONS AS WELL AS RECOMMENDING CAPTURING A REFERENCE SUBCUTANEOUS ELECTROCARDIOGRAM (S-ECG). THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25082283 ↗
• InjuryApr 28, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM PRESENTED TO THE EMERGENCY ROOM (ER). UPON REVIEW, IT WAS NOTED THAT THIS S-ICD SYSTEM DELIVERED AN INAPPROPRIATE ELECTRIC SHOCK DUE TO OVERSENSING AND NOISE. LOW AMPLITUDE WAS ALSO NOTED. ISOMETRIC TESTING WAS PERFORMED AND THE NOISE WAS UNABLE TO REPRODUCE. FURTHER ISOMETRIC TESTING AND A CHEST X-RAY WERE RECOMMENDED TO RULE OUT LEAD INTEGRITY. THE REPRESENTATIVE REPROGRAMMED TO PRI AND DISCHARGED THE PATIENT. THEN, A REVISION PROCEDURE WAS PERFORMED AND THE S-ICD SYSTEM WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25023057 ↗
• MalfunctionApr 11, 2026High impedance; Over-Sensing; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE PATIENT HAD AN UNTREATED EPISODE STORED DUE TO T-WAVE OVERSENSING. THE SENSING VECTOR WAS SET TO THE SECONDARY VECTOR. LATER, DURING A TACHYCARDIA EPISODE, THE DEVICE HAD DIFFICULTY CONVERTING THE ARRHYTHMIA. THE ARRHYTHMIA SELF-CONVERTED. ALSO, THE HIGH ENERGY SHOCK IMPEDANCE WAS 100 OHMS, WHICH IS HIGH BUT WITHIN NORMAL LIMITS. AN X-RAY WAS DONE AND TECHNICAL SERVICES ADVISED SOME TESTING AND PROGRAMMING OPTIONS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850634 ↗
• InjuryMar 31, 2026Failure to Convert Rhythm

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED TWO SHOCKS AS APPROPRIATE THERAPY THAT DID NOT CONVERT THE PATIENT'S RHYTHM, WITH THE RHYTHM TERMINATING ON ITS OWN. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA, WITH FURTHER IN CLINIC EXAMINATION RECOMMENDED TO CONFIRM SYSTEM PLACEMENT. X-RAY IMAGING WAS PERFORMED AND BASED ON IT; IT WAS SUSPECTED THAT THE ELECTRODE HAD SUBOPTIMAL POSITION. AT A LATER DATE, THIS S-ICD SYSTEM WAS EXPLANTED AND A NEW TRANSVENOUS SYSTEM IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747199 ↗
• InjuryFeb 23, 2026Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION THAT THE SYSTEM WAS ABANDONED DUE TO INAPPROPRIATE SHOCKS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED. IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE. A TRANSVENOUS SYSTEM WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ABANDONED SYSTEM REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 24422107 ↗
• MalfunctionFeb 19, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION FOR THE H11 SECTION OF TAB H. DEVICE MANUFACTURERS ONLY. IT WAS REPORTED THAT THE PATIENT HAD AN INAPPROPRIATE SHOCK DUE TO OVERSENSING OF ELECTRO-MECHANICAL NOISE. THE PATENT WAS USING A FOOT PLATE FOR NEUROPATHY AT THE TIME OF THE SHOCK. ALSO, THE LOW ENERGY SHOCK IMPEDANCE MEASUREMENTS HAVE BEEN IN THE 130-OHM RANGE. THIS IS HIGH BUT WITHIN NORMAL LIMITS. TECHNICAL SERVICES DISCUSSED THE FINDINGS WITH THE CALLER. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24390891 ↗
• InjuryFeb 18, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED AN INAPPROPRIATE SHOCK DUE TO OVERSENSING OF NOISE. SUBSEQUENTLY, THIS PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE NOISE COULD BE REPRODUCED WITH ARM MOVEMENTS; THEREFORE, TACHYCARDIA THERAPY WAS DEACTIVATED AT THIS TIME. IT WAS NOTED THAT FURTHER TESTING WILL BE CONDUCTED TO ASCERTAIN IF REPLACEMENT OR REPROGRAMMING IS NECESSARY. IT WAS ALSO STATED THAT THE SIGNAL AMPLITUDE HAD BEEN DECREASING OVER THE PAST SIX MONTHS. TECHNICAL SERVICES (TS) ANALYZED DEVICE EPISODE DATA AND CONFIRMED THAT THE INAPPROPRIATE SHOCK WAS DUE TO OVERSENSING OF MYOPOTENTIAL NOISE AND A DECREASE IN R-WAVE AMPLITUDES. THIS OCCURRED IN THE SECONDARY VECTOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS S-ICD SYSTEM REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24377831 ↗
• InjuryJan 30, 2026Defibrillation/Stimulation Problem; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THIS ELECTRODE EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF 18 OHMS. THE PATIENT REPORTED FEELING A SHOCKING SENSATION WHEN THE IMPEDANCE IS MEASURED. AFTER A SHOCK DELIVERY THERE WAS FLATLINE AND THERE WERE QUESTIONS IF THE DEVICE HAD DELIVERED THE SHOCK, THE ALTERNATE SENSING VECTORS WAS NOTED TO BE FLATLINE WITH MOSTLY UNDERSENSING OF QRS COMPLEXES. THIS ELECTRODE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 24222684 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24109013 ↗

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-0151-2023 · Sep 30, 2022 · Open, Classified
  EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
• Z-0152-2023 · Sep 30, 2022 · Open, Classified
  EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, 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-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-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