EMBLEM™ S-ICD A209Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,788 adverse event reports that list this exact device (DI 00802526544101), received between Aug 28, 2015 and Sep 14, 2026 — classified as 7 deaths, 5,516 injuries, 1,265 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (5,130 reports).

1 FDA recall record name this device's identifier, 1 still open.

10 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.

Recalls naming this device

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 problems

Recent adverse event reports

The 25 most recent of 6,788 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026High impedance; Impedance Problem; Interrogation Problem

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) and electrode exhibited elevated system impedance measurement of 120 Ohms. A 10J shock was performed, and a delivered shock impedance of 124 Ohms was noted. It was noted that the S-ICD was scheduled for a routine battery replacement, and it was not possible to retrieve device data because the S-ICD was at End of Life (EOL). Technical Services (TS) reviewed next steps for the electrode included surgical revision or defibrillation threshold (DFT) testing. If DFTs were unsuccessful, the options were to surgically revise or consider a different implantable system, as it was possible this may be a higher DFT patient. Fluoroscopic imaging may also be used to look for adipose tissue. Additional information received reported that the electrode had been implanted in a suboptimal location, to the left of the sternum. Subsequently, the S-ICD was explanted, the electrode was surgically abandoned, and a new S-ICD system was implanted. No additional adverse patient effects were reported. The S-ICD was retained by the hospital and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748335 ↗
• MalfunctionAug 14, 2026No Audible Alarm; Interrogation Problem

  This supplemental is being submitted to correct the tab B. Adverse Event/Product Prob section for the Adverse Event/Product Problem. The codes should be Product Problem and Serious Injury.The Outcomes Attrib to Adv Event code should be Hospitalization - initial or prolonged.This supplemental report is being filed to provide additional information that the product has been explanted and returned. There were no additional adverse patient effects.It was reported that this device could not be interrogated. Magnet application over the device did not yield tones. The device has been implanted greater than ten years and the patient has not been compliant with follow-ups. Technical Services suspects the battery is dead and discussed some options, such as a life vest. There were no adverse patient effects. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254248 ↗
• MalfunctionJun 11, 2026Nonstandard Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS S-ICD WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED, BUT THE BATTERY STILL SUPPORTED FULL DEVICE FUNCTION. DETAILED ANALYSIS CONFIRMED THE IDENTIFIED HIGH CURRENT DRAIN WAS A RESULT OF A COMPROMISED CAPACITOR. THIS RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE CAPACITOR WAS COMPROMISED DUE TO THE PRESENCE OF EXCESS HYDROGEN IN THE DEVICE CASE. BOSTON SCIENTIFIC ISSUED A FIELD SAFETY NOTICE REGARDING A SUBSET OF EMBLEM DEVICES THAT HAVE A POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE EMBLEM S-ICD ACCELERATED DEPLETION ADVISORY POPULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474164 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible

  IT WAS REPORTED THAT, WHEN ATTEMPTING TO CHECK THIS DEVICE PRIOR TO A SURGERY, THE PROGRAMMER HAD A MESSAGE INDICATING AN INCOMPATIBLE DEVICE WAS DETECTED. THE PATIENT STATED HE HAD HEARD BEEPING. THE PRODUCT HAS NOT BEEN CHECKED FOR A LONG TIME. THE IMPLANT WAS OVER TEN YEARS AGO. TECHNICAL SERVICES REVIEWED THE INFORMATION AND DISCUSSED THAT THE SOFTWARE VERSION NEEDED TO BE UPGRADED. ALSO, THE DEVICE MAY BE AT END-OF-LIFE. TECHNICAL SERVICES ADVISED THAT A MAGNET SHOULD BE PLACED OVER THE DEVICE FOR THE SURGERY PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741994 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS PART OF A SYSTEM REVISION DUE TO STAPHYLOCOCCUS AUREUS INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS S-ICD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 24506114 ↗
• MalfunctionFeb 20, 2026Nonstandard Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402888 ↗
• MalfunctionFeb 16, 2026Nonstandard Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344781 ↗
• MalfunctionFeb 13, 2026Nonstandard Device

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DEVICE WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331086 ↗
• MalfunctionJan 26, 2026Signal Artifact/Noise; Nonstandard Device; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXPERIENCED A SHOCK. UPON REVIEW, TECHNICAL SERVICES (TS) OBSERVED TREATED AND UNTREATED EPISODES ALONG WITH NOISE AND OVERSENSING THAT HAD MOVEMENT RELATED APPEARANCE. TS RECOMMENDED OBTAINING AN X RAY AND PROGRAMMING TO SECONDARY VECTOR. THE NOISE COULD NOT BE RECREATED WITH ISOMETRICS TESTING WHILE IN THE CLINIC. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS S-ICD WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD).

  Patient problems: Electric Shock

  MAUDE report 24177018 ↗
• MalfunctionJan 14, 2026No Audible Alarm; Interrogation Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) COULD NOT BE INTERROGATED. NO TONES WERE EMITTED WHEN A MAGNET WAS PLACED OVER THE DEVICE. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS INCLUDING ATTEMPTING WITH A NEW PROGRAMMER. THIS DEVICE HAS BEEN IN SERVICE APPROXIMATELY NINE YEARS AND WILL BE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. LATER THIS S-ICD WAS EXPLANTED FOR NORMAL BATTERY DEPLETION WITH SUCCESSFUL REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068484 ↗
• MalfunctionNov 5, 2025Defective Device; Defective Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED. DETAILED ANALYSIS CONFIRMED HIGH AMOUNTS OF HYDROGEN WITHIN THE DEVICE. BATTERY WAS FOUND TO BE DEPLETED. BATTERY DEPLETION WAS DUE TO HIGH HYDROGEN INDUCED LEAKAGE OF THE C2V35 CAPACITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23474866 ↗
• MalfunctionOct 30, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS DEVICE HAD NOT BEEN INTERROGATED IN OVER 3 YEARS. INTERROGATION WAS BEING PERFORMED NOW AND THE CALLER STATED IT WAS TAKING A LONG TIME AND THE PROGRAMMER WAS STUCK ON THE PROGRESS BAR AT 100% COMPLETE. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT INSTRUCTED THE CALLER TO RESTART THE PROGRAMMER WHICH RESULTED IN SUCCESSFUL STATED INTERROGATION AND UPDATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THIS DEVICE WAS SUBSEQUENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION. THE PRODUCT IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS REPORT WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423761 ↗
• MalfunctionOct 27, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399326 ↗
• MalfunctionOct 27, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393304 ↗
• InjuryOct 27, 2025High impedance; High impedance

  IT WAS REPORTED THAT, DURING A REPLACEMENT PROCEDURE, THE LOW ENERGY SHOCK IMPEDANCE WAS 165 OHMS. THIS IMPEDANCE IS HIGH BUT WITHIN NORMAL LIMITS. THE LOCAL REPRESENTATIVE SUSPECTS THERE IS A LOT OF ADIPOSE TISSUE. THE PATIENT IS SIX FEET TALL AND WEIGHS OVER 260 POUNDS. TECHNICAL SERVICES REVIEWED THE DEVICE DOWNLOADED DATA AND CONFIRMED THE IMPEDANCES HAVE BEEN INCREASING SINCE THE DEVICE IMPLANT IN 2015. THE DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS SUCCESSFULLY PLACED ONTO THE CHRONIC ELECTRODE. THERE WERE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389989 ↗
• InjurySep 23, 2025Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EMITTED A BATTERY DEPLETION CODE. MOREOVER, THIS DEVICE HAS 4 PERCENT REMAINING OF BATTERY LONGEVITY TO ELECTIVE REPLACEMENT INDICATOR (ERI). A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED REPLACEMENT. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS RECEIVED INDICATING THAT THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23120020 ↗
• MalfunctionSep 19, 2025Telemetry Discrepancy; Defective Device; Telemetry Discrepancy; Defective Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) COULD NOT BE INTERROGATED WITH A COMMUNICATOR IN CLINIC. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING AND SUGGESTED THAT PATIENT WORK WITH CLINIC TO VERIFY RADIO FREQUENCY (RF) SETTINGS AS WELL AS INTERROGATION WITH A PROGRAMMER. LATER, THIS S-ICD WAS EXPLANTED DURING SCHEDULED GENERATOR CHANGE OUT. A NEW S-ICD OF A DIFFERENT MODEL WAS SUCCESSFULLY PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099873 ↗
• InjurySep 16, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED OVERSENSING OF NOISE AND MORPHOLOGY CHANGES RESULTING IN AN INAPPROPRIATE SHOCK. THE SYSTEM WAS TESTED IN CLINIC WITH NOISE ABLE TO BE REPRODUCED. X-RAYS WERE TAKEN WITH NO INDICATION OF DAMAGE PRESENT. THIS SYSTEM WAS THEN REPROGRAMMED TO THE PRIMARY VECTOR TO MITIGATE FURTHER OVERSENSING. THIS SYSTEM WAS ELECTRICALLY ABANDONED AND EXPECTED TO BE EXPLANTED AT A LATER DATE. A TRANSVENOUS SYSTEM WAS THEN IMPLANTED AS A REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23068366 ↗
• MalfunctionAug 21, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22859838 ↗
• MalfunctionAug 20, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856367 ↗
• MalfunctionAug 20, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856330 ↗
• MalfunctionAug 18, 2025Over-Sensing; Defective Device; Over-Sensing; Defective Device

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED OVERSENSING. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. EXPLANTED DUE TO BATTERY REPLACEMENT

  Patient problems: Insufficient Information

  MAUDE report 22835284 ↗
• InjuryAug 15, 2025Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.ACCORDING TO THE ADDITIONAL INFORMATION, THIS S-ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819817 ↗
• MalfunctionAug 12, 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 HAD AN INAPPROPRIATE SHOCK DUE TO T-WAVE OVERSENSING VIA REDUCED INTRINSIC AMPLITUDES. THE SENSING VECTOR WAS SET TO THE SECONDARY VECTOR. ALSO, THE DEVICE HAS REACHED END-OF-LIFE BATTERY STATUS AND THE CLINIC IS WONDERING HOW LONG THERAPY WILL BE AVAILABLE. TECHNICAL SERVICES REVIEWED THE DATA AND DISCUSSED THE OPTIONS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22783539 ↗
• InjuryAug 7, 2025High impedance; High impedance

  THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION REGARDING PRODUCT ANALYSIS. IT WAS REPORTED THAT THE SHOCK IMPEDANCE WAS GREATER THAN 200 OHMS. THE IMPEDANCE WENT FROM 180 OHMS LAST DECEMBER UP TO 235 OHMS THIS JUNE. THE PULSE GENERATOR HAD NORMAL BATTERY DEPLETION AFTER GREATER THAN NINE YEARS OF IMPLANT TIME. SO, THE DOCTOR REPLACED THE PULSE GENERATOR ONTO THE CHRONIC ELECTRODE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738071 ↗

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-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-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