EMBLEM™ S-ICD Electrode Delivery System 4712Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00802526591907), received between Nov 2, 2019 and Sep 9, 2026 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after the implant procedure for this subcutaneous implantable cardioverter defibrillator (S-ICD), it failed all sensing vectors due to the patients rhythm R-waves being too small. Previously the S-ICD system had passed using the secondary sensing vector. Additionally, it was noted that during the implant procedure there two instances of tunneling with the tunneling tool. No further complications were observed due to the tunneling. Technical Services (TS) was consulted and discussed troubleshooting options, with further examination recommended for the system sensing. A revision was performed the day after implant procedure since the implanted electrode migrated. No additional adverse patient effects were reported.

  Patient problems: Perforation

  MAUDE report 50691670 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this device experienced an S-ICD electrode delivery system (EDS) perforation into the thoracic cavity during suprasternal tunneling. The EDS was withdrawn, and the patient was monitored for bleeding, oxygen saturation, and vital signs, with no abnormalities noted. Tunneling was successfully performed again, and post-operative ultrasound and CT showed no abnormal findings. This SICD system remains in service.

  Patient problems: Perforation

  MAUDE report 50216503 ↗
• MalfunctionJul 17, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING THE ELECTRODE POSITIONING PORTION OF AN IMPLANT PROCEDURE, WHEN THE DOCTOR STARTED TO PEEL THE SHEATH FOR THE STERNAL TUNNEL, THE SHEATH BROKE APART BUT WAS STILL ABLE TO BE REMOVED. THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332172 ↗
• InjuryFeb 13, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE FOR THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM, THE PHYSICIAN BELIEVED THE TUNNELING TOOL MAY HAVE GOTTEN BETWEEN THE PATIENT'S RIBS. THE PHYSICIAN STOPPED, PULLED BACK, AND EVALUATED THE PATIENT'S VITALS AND TOOK MULTIPLE FLUOROSCOPY VIEWS. NO INJURY WAS OBSERVED, BUT THE PATIENT COMPLAINED OF SORENESS IN THE STERNAL AREA AFTER THE PROCEDURE. THE PHYSICIAN BELIEVED TOO STEEP OF AN ANGLE WAS USED IN AN ATTEMPT TO STAY DIRECTLY ON THE STERNUM. THE FINAL SYSTEM PLACEMENT WAS EXCELLENT AND REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Implant Pain

  MAUDE report 16363490 ↗
• DeathJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE FIRST TUNNELING, THE PATIENT WENT INTO CARDIORESPIRATORY ARREST AND DIED. CARDIOPULMONARY RESUSCITATION WAS PERFORMED BUT WAS UNSUCCESSFUL. THE OFFICIAL CAUSE OF DEATH WAS NOT KNOWN. NO PRODUCTS WERE IMPLANTED AT THE TIME OF DEATH.

  Patient problems: Cardiac Arrest

  MAUDE report 11938818 ↗
• InjuryNov 6, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT FOLLOWING POCKET CLOSURE AT AN SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) IMPLANT A LATERAL X-RAY WAS PERFORMED WHICH SHOWED THE ELECTRODE HAD INADVERTENTLY BEEN IMPLANTED IN THE LOWER SIDE OF THE STERNUM. IT WAS BELIEVED THAT THE TUNNELING TOOL HAD BEEN SLIGHTLY NEAR THE ENSIFORM CARTILAGE WHEN THE ELECTRODE WAS BEING POSITIONED. THE ELECTRODE WAS SUCCESSFULLY REPOSITIONED WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Code Available

  MAUDE report 10805783 ↗
• InjuryNov 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS IMPLANTED. IT WAS NOTED THE PATIENT HAD CONGENITAL HEART DISEASE AND UNDERWENT A STERNOTOMY IN THE PAST, BUT WITHOUT WIRES. THE ELECTRODE WAS PLACED ON THE RIGHT PARASTERNAL POSITION. THE PATIENT'S STERNUM WAS OBSERVED TO BE SOMEWHAT ROTATED. THE SYSTEM WAS IMPLANTED USING THE TWO-INCISION TECHNIQUE AND AUTOMATIC SETUP WAS PERFORMED, WITH THE DEVICE PICKING THE SECONDARY VECTOR. HOWEVER, THE DEVICE APPEARED TO BE SENSING THE P-WAVES AND THE VECTOR WAS MANUALLY CHANGES TO PRIMARY. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS SUCCESSFUL AND THE SHOCK IMPEDANCE MEASUREMENT WAS 46 OHMS. POST-IMPLANT X-RAYS WERE REVIEWED AND THE ELECTRODE PLACEMENT ALMOST APPEARED TO BE SUBSTERNAL. TWO DAYS AFTER THE IMPLANT, THE PHYSICIAN CONTACTED THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE TO REPORT A CT SCAN SHOWED THE TIP OF THE ELECTRODE WAS INTRATHORACIC. THE PATIENT WAS STABLE AND THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THE PHYSICIAN PLANNED A REVISION PROCEDURE FOR THE ELECTRODE. THE PHYSICIAN NOTED THAT DURING TUNNELING THEY DID NOT BELIEVE THEY HAD A VERY AGGRESSIVE ANGLE AND ALSO THAT THEY COULD NO

  Patient problems: Perforation

  MAUDE report 9270051 ↗

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-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-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-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-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