EMBLEM™ S-ICD Programmer 3200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00802526586507), received between May 5, 2020 and Jun 7, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Use of Device Problem; Application Program Problem; Interrogation Problem; Use of Device Problem; Application Program Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PROGRAMMER COULD NOT INTERROGATE THE PULSE GENERATOR. THE PROGRAMMER HAD AN ERROR MESSAGE. TECHNICAL SERVICES SUSPECTS THIS IS DUE TO THE PROGRAMMER HAVING OLDER SOFTWARE THAN THE DEVICE. A LOCAL REPRESENTATIVE WILL BE CONTACTED TO GET THE LATEST SOFTWARE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628505 ↗
• InjuryDec 19, 2020Defibrillation/Stimulation Problem; Device Displays Incorrect Message; Communication or Transmission Problem; Defibrillation/Stimulation Problem; Device Displays Incorrect Message; Communication or Transmission Problem

  IT WAS REPORTED THAT THIS PATIENT IMPLANTED WITH A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE. DURING THE PROCEDURE, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF). A HEALTH CARE PROFESSIONAL (HCP) ATTEMPTED TO DELIVER A SHOCK THROUGH THE IMPLANTED DEVICE BY PRESSING THE SHOCK BUTTON ON THIS PROGRAMMER. HOWEVER, THE PROGRAMMER DISPLAYED A MESSAGE THAT THERE WERE NO STORED S-ECGS FOR THE PATIENT AND SHOCK THERAPY WAS NOT DELIVERED. EXTERNAL RESCUE WAS DELIVERED TO TERMINATE THE RHYTHM. FURTHER REVIEW WAS PERFORMED BY A LOCAL FIELD REPRESENTATIVE AND DETERMINED THAT THE PROGRAMMER LOST TELEMETRY WITH THE S-ICD AND RESULTED IN THE INABILITY TO DELIVER THE SHOCK COMMAND TO THE S-ICD. THIS PRODUCT REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THE PROGRAMMER WAS LATER RETURNED WITH NO ADDITIONAL INFORMATION RELATED TO THE PREVIOUS REPORTED CLINICAL OBSERVATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11042762 ↗
• InjuryMay 5, 2020Failure to Power Up; Defibrillation/Stimulation Problem; Data Problem; Noise, Audible; Failure to Power Up; Defibrillation/Stimulation Problem; Data Problem; Noise, Audible

  THIS SUPPLEMENTAL REPORT IS BEING FILLED TO INCLUDE DEVICE ANALYSIS INFORMATION.

  Patient problems: No Code Available

  MAUDE report 10027211 ↗

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-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