EMBLEM™ S-ICD 3401 (UDI 00802526585968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,039 adverse event reports that list this exact device (DI 00802526585968), received between Apr 11, 2017 and Sep 29, 2026 — classified as 5 deaths, 852 injuries, 182 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (442 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,039 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 25, 2026Impedance Problem

  It was reported that the system was being checked prior to the patient getting an MRI. Upon interrogation, the programmer displayed a high impedance message. The low energy impedances were greater than 400 ohms. Also, the therapy was off. There was some programming done earlier and the Auto Setup feature had not been run. Now, the device could not be programmed to the MRI mode due to the high impedances, and the likelihood that the Auto Set feature had not been completed. Technical Services advised if the Auto Setup feature was run previously, and a high impedance is encountered, it can cause the therapy to turn off. The doctor elected to leave the therapy off and do the MRI anyway. A review of the device downloaded data confirmed the impedances have been increasing since 2022. There were no adverse patient effects. The system remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896346 ↗
• MalfunctionSep 15, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776033 ↗
• MalfunctionSep 4, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50600897 ↗
• MalfunctionJul 31, 2026Over-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 for what appeared to be atrial fibrillation (AF) with rapid ventricular response (RVR). Technical Services (TS) was contacted and noted that the T wave became larger and that there was T wave oversensing before the shock. This electrode remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50099534 ↗
• InjuryJul 17, 2026Failure to Convert Rhythm; Unexpected Therapeutic Results; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT GOT A SHOCK FOR A TRUE VENTRICULAR TACHYCARDIA. THE FIRST SHOCK ACCELERATED THE RHYTHM TO VENTRICULAR FIBRILLATION. TECHNICAL SERVICES REVIEWED THE ELECTROGRAMS FROM THE DEVICE. FOLLOWING THE SHOCK THAT INDUCED THE VENTRICULAR FIBRILLATION, THERE IS SIGNIFICANT UNDERSENSING WHICH DELAYS THERAPY. A SECOND SHOCK IS EVENTUALLY DELIVERED AFTER A FULL MINUTE HAS ELAPSED. THIS SHOCK CONVERTS THE RHYTHM FOR A FEW SECONDS, BUT A THIRD SHOCK IS REQUIRED TO EVENTUALLY CONVERT THE ARRHYTHMIA COMPLETELY. THE DOCTOR ELECTED TO EXPLANT AND REPLACE BOTH THE PULSE GENERATOR AND THE ELECTRODE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: Ventricular Fibrillation

  MAUDE report 25860591 ↗
• InjuryJul 16, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT HEARD BEEPING FROM THE DEVICE. TECHNICAL SERVICES REVIEWED THE DEVICE DOWNLOADED DATA. THE WEEKLY LOW-ENERGY SHOCK IMPEDANCES HAVE BEEN FLUCTUATING FROM THE 90-OHM RANGE TO GREATER THAN 400 OHMS. THE MOST RECENT READING WAS AROUND 99 OHMS. TECHNICAL SERVICES ADVISED CONSIDERING THAT THE PATIENT IS UNPROTECTED AND THAT ELECTRODE REPLACEMENT IS RECOMMENDED. THERE WERE NO KNOWN ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25846226 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN REASON AND REPLACED WITH A NON BOSTON SCIENTIFIC TRANSVENOUS DEVICE SYSTEM. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE DID NOT KNOW THE REASON WHY. THIS S-ICD IS EXPECTED TO BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736767 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25379565 ↗
• MalfunctionMay 26, 2026Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT'S SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED A TREATED SHOCK. THE RECORDED RHYTHM SHOWED VARIABLE MORPHOLOGIES, RAISING UNCERTAINTY WHETHER THE EPISODE REPRESENTED ATRIAL TACHYCARDIA WITH ABERRANT CONDUCTION OR VENTRICULAR TACHYCARDIA. FOLLOWING THERAPY, THE RATE REMAINED ELEVATED. TECHNICAL SERVICES NOTED OCCASIONAL UNDERSENSING RELATED TO SIGNAL BEHAVIOR AND SENSING PROFILE CHARACTERISTICS. IT REMAINS UNCLEAR WHETHER THE SHOCK WAS APPROPRIATE OR INAPPROPRIATE, AND ELECTROPHYSIOLOGY REVIEW IS REQUIRED TO DETERMINE RHYTHM CLASSIFICATION. THE ELECTRODE REMAINS IN SERVICE. NO ADVERSE PATIENT IMPACT WAS REPORTED

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25286199 ↗
• InjuryApr 24, 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 EXHIBITED OVERSENSING OF NOISY SIGNALS AND T-WAVES. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED STORED DATA. TS RECOMMENDED FURTHER IN CLINIC EXAMINATION AND X-RAY IMAGING TO DETERMINE POSSIBLE REPOSITIONING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT A LATER DATE, THIS S-ICD SYSTEM DELIVERED TWO SHOCKS AS INAPPROPRIATE THERAPY DUE T-WAVE OVERSENSING. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24986207 ↗
• MalfunctionApr 10, 2026Signal Artifact/Noise; Fracture

  IT WAS REPORTED THAT A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED MECHANICAL NOISE ON THE PRESENTING SUBCUTANEOUS ELECTROCARDIOGRAM (S-ECG) HOWEVER, NO INAPPROPRIATE THERAPY OCCURRED AS A RESULT. THE PATIENT WAS EVALUATED IN CLINIC, AND THE NOISE WAS REPRODUCIBLE IN BOTH THE SECONDARY AND ALTERNATE SENSING VECTORS. A CHEST X-RAY WAS PERFORMED, WHICH IDENTIFIED A TIGHT LOOP OF THE ELECTRODE IN THE POCKET AREA. BASED ON THESE FINDINGS, THERE WAS SUSPICION OF A LEAD FRACTURE. THE CLINICAL PLAN WAS TO EITHER CONTINUE MONITORING THE DEVICE USING THE PRIMARY VECTOR OR PROCEED WITH LEAD REPLACEMENT, AT THE DISCRETION OF THE HOSPITAL. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845268 ↗
• InjuryMar 4, 2026High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Under-Sensing; Migration

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DELIVERED AN INAPPROPRIATE ELECTRIC SHOCK DUE TO OVERSENSING. LOW AMPLITUDE AND UNDERSENSING WAS ALSO DETERMINED. A X RAY WAS PERFORMED AND IT WAS NOTED THAT THE ELECTRODE WAS MOVED AND THE S-ICD WAS IN ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS ALSO NOTED THAT THE SHOCK IMPEDANCE WAS HIGH. THE PLAN IS REPLACING THE ENTIRE SYSTEM. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE ELECTRODE WAS EXPLANTED AND REPLACED. WHILE, THE S-ICD WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24513016 ↗
• InjuryFeb 16, 2026High impedance; Failure to Convert Rhythm; Migration

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS. UPON REVIEW, IT WAS NOTED THAT THE SHOCK IMPEDANCE AT DEFIBRILLATION THRESHOLD (DFT) TEST IMPLANT WAS 75 OHMS. TROUBLESHOOTING OPTIONS WERE DISCUSSED AND RECOMMENDED. AN X-RAY WAS PERFORMED AND IT WAS OBSERVED THAT THE ELECTRODE WAS MOVED. THEN, A DFT TEST WAS MADE AND THE S-ICD FAILED IN TERMINATING VENTRICULAR FIBRILLATION (VF). SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE ELECTRODE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock

  MAUDE report 24345686 ↗
• MalfunctionFeb 12, 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 ONE SHOCK AS INAPPROPRIATE THERAPY. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED STORED DATA, WITH OVERSENSING OF NOISY SIGNALS NOTED. TS DISCUSSED STORED DATA, AS WELL AS PROGRAMMING OPTIONS SINCE THE PATIENTS RHYTHM HAD A LOW AMPLITUDE. TS DISCUSSED TROUBLESHOOTING STEPS FOR IN CLINIC EXAMINATION. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24326268 ↗
• InjuryFeb 9, 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 24298268 ↗
• InjuryJan 22, 2026Impedance Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM HAD AN INCREASE IN ITS SYSTEM IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA, WITH ADIPOSE TISSUES SUSPECTED AS THE CAUSE IN THE INCREASE OF THE MEASUREMENTS. THE SYSTEM IMPEDANCE MEASUREMENTS HAD INCREASE BUT THEY WERE STILL WITHIN RANGE. AT A LATER DATE, AN ELECTRODE REVISION WAS PERFORMED AND A NEW ELECTRODE WAS IMPLANTED. THE SYSTEM IMPEDANCE WAS STILL ELEVATED, BUT IT WAS STILL WITHIN RANGE. A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED AND THE SHOCK IMPEDANCE MEASUREMENT WAS WITHIN RANGE. TS DISCUSSED TROUBLESHOOTING OPTIONS AND FURTHER EXAMINATION. AT A LATER DATE, THIS ELECTRODE WAS EXPLANTED. A NEW ELECTRODE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148827 ↗
• MalfunctionDec 16, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Over-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 AVAILABLE PROGRAMMING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23818516 ↗
• InjuryDec 11, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT, DURING AN OFFICE FOLLOW-UP, THE LOW ENERGY SHOCK IMPEDANCE WAS VARYING BETWEEN 165 AND 175 OHMS. TECHNICAL SERVICES REVIEWED THE DEVICE DOWNLOADED DATA. THE MOST LIKELY CONSIDERATION IS AN ELECTRODE COIL IN ADIPOSE TISSUE. THE IMPEDANCES ARE HIGH BUT WITHIN NORMAL LIMITS. TECHNICAL SERVICES DISCUSSED THE DATA WITH THE CLINIC. THE DOCTOR ELECTED TO EXPLANT AND REPLACE THE ELECTRODE WITH A NEW ONE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783187 ↗
• MalfunctionDec 10, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEADLESS PACEMAKER AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED AN INAPPROPRIATE ELECTRIC SHOCK DUE TO OVERSENSING. UPON REVIEW, IT WAS NOTED SLOW VENTRICULAR TACHYCARDIA (VT), WHICH CHANGED THE AMPLITUDE. OVERSENSING LED TO INAPPROPRIATE ELECTRIC SHOCK. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23770130 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23671358 ↗
• InjuryNov 14, 2025Failure to Convert Rhythm; Failure to Read Input Signal; Under-Sensing; Low impedance; Malposition of Device; Impedance Problem; Failure to Convert Rhythm; Failure to Read Input Signal; Under-Sensing; Low impedance; Malposition of Device; Impedance Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM RECORDED A SYSTEM IMPEDANCE MEASUREMENT LOWER THAN 30 OHMS. THE SIGNAL IN THE PRIMARY SENSING VECTOR WAS NOTED TO BE SMALL AND WITH SOME UNDERSENSING NOTED. THE PATIENT REQUIRED TWO SHOCKS TO BE CONVERTED AND IN THAT EPISODE THE SHOCK IMPEDANCE WAS NOTED TO BE LOW WITHING NORMAL LIMITS 30 OHMS. A CHEST X RAY SHOWED THE ELECTRODE WAS SLIGHTLY BOWED TOWARDS THE S-ICD. THIS S-ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560061 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23543979 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23538511 ↗
• InjuryNov 7, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED NOISE IN PRIMARY AND SECONDARY VECTORS WHICH WAS REPRODUCIBLE WITH ARM MOVEMENT. ALTERNATE VECTOR PASSED. TECHNICAL SERVICES (TS) REVIEWED NOTING PREVIOUS INAPPROPRIATE SHOCKS WITH MYOPOTENTIAL NOISE. SHOCK IMPEDANCE MEASUREMENTS WERE HIGH WITHIN NORMAL RANGE. THIS ELECTRODE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23496653 ↗

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-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