SQ-RX® PULSE GENERATOR 1010 (UDI 00802526562808)Recalls & reported problems

Summary

The FDA's MAUDE database contains 596 adverse event reports that list this exact device (DI 00802526562808), received between Dec 2, 2014 and Dec 26, 2025 — classified as 3 deaths, 377 injuries, 216 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (130 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 596 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE SCHEDULED CHANGE OUT PROCEDURE FOR THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), HAD THE ASSOCIATED ELECTRODE STUCK ON ITS HEADER, WITH UNABLE TO BE REMOVED. THIS DEVICE REMAINS IN SERVICE. AT THIS TIME, THERE IS NO INDICATION A NEW SYSTEM OR DEVICE WILL BE IMPLANTED OR WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THE DEVICE REMAINS IMPLANTED, WITH THE PATIENT REFERRED TO ANOTHER FACILITY FOR REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT A LATER DATE, THIS S-ICD WAS SUCCESSFULLY EXPLANTED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897064 ↗
• InjuryJul 10, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT, DURING AN OFFICE FOLLOW-UP, THE PULSE GENERATOR BATTERY STATUS WAS AT END-OF-LIFE. THE DEVICE HAS BEEN IMPLANTED GREATER THAN TEN YEARS. THE PATIENT HAS BEEN LOST TO FOLLOW-UP. THE CLINIC MAY SCHEDULE A REPLACEMENT PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468433 ↗
• InjuryAug 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time; Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). A LONG CHARGE (LC) ERROR WAS ALSO FOUND, INDICATING THAT THE CHARGE TIME EXCEEDED THE LIMIT. IT WAS RECOMMENDED THAT THE DEVICE BE EXPLANTED AND REPLACED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE S-ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081590 ↗
• InjuryApr 11, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BACK IN (B)(6) 2022. RECENTLY, THE PATIENT RECEIVED FOUR INAPPROPRIATE SHOCKS DUE TO OVERSENSING OF MYPOTOENTIAL NOISE. ADDITIONALLY, THERE WAS LONG CHARGE TIMES AVERAGING BETWEEN 20-44 SECONDS. TROUBLESHOOTING WAS PERFORMED AND THE NOISE COULD BE RE-CREATED. AT SOME POINT, THE PATIENT WILL BE IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19092517 ↗
• InjuryJan 29, 2024Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DELIVERED ONE SHOCK AS INAPPROPRIATE THERAPY DUE TO A SUSPECTED SUPRAVENTRICULAR TACHYCARDIA (SVT). TECHNICAL SERVICES (TS) DISCUSSED THE DEVICE PROGRAMMED SETTINGS AND AVAILABLE PROGRAMMING OPTIONS. TS ALSO INFORMED THE CALLING FIELD REPRESENTATIVE THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS UNDER AN ADVISORY NOTICE FOR IT TO BE REPLACED WITHIN 20 DAYS OF IT REACHING ERI, SO IT RECOMMENDED FOR THE DEVICE TO BE REPLACED. THE FIELD REPRESENTATIVE INDICATED THEY WOULD DISCUSS IT WITH THE PATIENTS PHYSICIAN. THE DEVICE REMAINS IN SERVICE AND THERE IS NO INDICATION A REPLACEMENT PROCEDURE HAS TAKEN PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18597019 ↗
• InjuryOct 20, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXHIBITING POSSIBLE BATTERY ISSUES AND SHORTENED REPLACEMENT INTERVAL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED DEVICE REPLACEMENT. S-ICD DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980648 ↗
• InjurySep 15, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. IT HAD BEEN IMPLANTED GREATER THAN SEVEN YEARS. THE LAB ANALYSIS REVIEW OF THE DEVICE MEMORY FOUND THERE WAS A CHARGE-TIMEOUT A FEW MONTHS PRIOR TO EXPLANT. THIS INDICATES THAT THE DEVICE WAS UNABLE TO PROVIDE A SHOCK AT THAT TIME. THERE WERE ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760933 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse 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 SUSPECTED NICKEL ALLERGY. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS S-ICD WAS EXPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17599387 ↗
• MalfunctionAug 14, 2023Premature 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 A PREMATURE BATTERY DEPLETION (BD) ALERT WAS OBSERVED FOR THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) THAT WAS SCHEDULED FOR REPLACEMENT, AS END OF LIFE (EOL) HAD BEEN REACHED APPROXIMATELY 3 YEARS PRIOR. TECHNICAL SERVICES (TS) RECOMMENDED EXPLANT AS SOON AS POSSIBLE. THIS S-ICD REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS S-ICD WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540932 ↗
• InjuryAug 10, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE LONGEVITY FOR THIS DEVICE WAS 35% REMAINING IN MAY, HOWEVER TODAY'S LONGEVITY REMAINING WAS THE SAME AT 35%. THERE PERCENT REMAINING HAD NOT DECREMENTED. TECHNICAL SERVICES ADVISED THE PERCENT REMAINING MAY PLATEAU AT THIS TIME AND IS TO BE EXPECTED. LATER, THE DEVICE WAS SUCCESSFULLY REPLACED WITH ANOTHER. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THIS IS CONSIDERED A SERIOUS INJURY AS SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503996 ↗
• InjuryJun 28, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 200 OHMS, NOTED TO BE HISTORICALLY HIGH. THIS S-ICD WAS EXPLANTED AND REPLACED WITH A NEW S-ICD, WHICH REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217666 ↗
• MalfunctionJun 15, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING THE EXPLANT PROCEDURE, THE SETSCREW WAS STUCK. THE DOCTOR TRIED TWO WRENCHES WITHOUT SUCCESS. FINALLY, A HEMOSTAT WAS PLACED ON THE WRENCH. THE SETSCREW WAS SUCCESSFULLY UNDONE AND THE DEVICE WAS REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140659 ↗
• MalfunctionJun 6, 2023Difficult to Remove; Connection Problem; Difficult to Remove; Connection Problem

  IT WAS REPORTED THAT DURING THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXPLANT PROCEDURE DUE TO NORMAL BATTERY DEPLETION, THE ELECTRODE WAS FOUND TO BE STUCK IN THE HEADER DUE TO A SUSPECTED SET SCREW ISSUE. SOME MANEUVERS WERE PERFORMED, AND THE ELECTRODE WAS ABLE TO BE DISCONNECTED. SUBSEQUENTLY, THIS S-ICD WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS, WHILE THE ELECTRODE WAS RE-CONNECTED TO THE NEW S-ICD AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075445 ↗
• MalfunctionJun 1, 2023Difficult to Remove; Defective Device; Connection Problem; Material Integrity Problem; Difficult to Remove; Defective Device; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) GENERATOR REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION, A SET SCREW GOT STUCK AND WOULD NOT MOVE. MULTIPLE WRENCHES WERE USED AND WERE DAMAGED IN THE ATTEMPTS TO REMOVE THE SET SCREW. THE SILICONE SEAL WAS REMOVED FROM THE S-ICD AND SALINE INJECTED INTO THE HEADER. FINALLY, THE SET SCREW APPEARED TO BE RELEASED AND THE ELECTRODE CAME OUT OF THE PORT WITHOUT ISSUE. A NEW S-ICD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039968 ↗
• InjuryMay 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time; Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) HAD TRIGGERED CODE LC DUE TO CAPACITOR CHART TIME EXCEEDING LIMITATIONS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE INCREASE IN CHARGE TIME VALUES. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE HAS EXCEEDED ITS LONGEVITY EXPECTATIONS. DEVICE REPLACEMENT WAS RECOMMENDED. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17025435 ↗
• MalfunctionApr 27, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED NORMAL BATTERY DEPLETION. A REVISION PROCEDURE WAS PERFORMED, AND THE PHYSICIAN EXPERIENCED DIFFICULTY TO REMOVE THIS S-ICD AND THEN WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827009 ↗
• MalfunctionApr 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED A POWER SUPPLY (PS) CODE AFTER THE DELIVERY OF A COMMANDED SHOCK TO TEST THE SYSTEM PRIOR TO A GENERAL CHANGEOUT PROCEDURE. THIS S-ICD WAS ALREADY SCHEDULED FOR EXPLANT PRIOR TO THE DISPLAY OF THE PS CODE. THE S-ICD WAS SUCCESSFULLY REMOVED FROM SERVICE AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS S-ICD IS EXPECTED TO BE RETURNED BACK FROM THE FIELD FOR ANALYSIS, THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761244 ↗
• MalfunctionApr 11, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS CHANGED OUT. SHOCK IMPEDANCE MEASUREMENTS WERE NOTED TO HAVE BEEN HIGH AT 125 OHMS SINCE THE ORIGINAL IMPLANT AND TODAY WERE 163 OHMS. THIS S-ICD WAS EXPLANTED AND A NEW S-ICD WAS SUCCESSFULLY IMPLANTED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715649 ↗
• MalfunctionMar 29, 2023Difficult to Remove; Connection Problem; Difficult to Remove; Connection Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (S-ICD) WAS BEING REMOVED FOR NORMAL BATTERY DEPLETION. DURING THE PROCEDURE, THE ELECTRODE WAS FOUND TO BE STUCK IN THE HEADER. THE HEX WRENCH TURNED THE SET SCREW AND PULLED ON THE ELECTRODE TO REMOVE IT FROM THE HEADER, THE SCREW WAS RELEASED SUCCESSFULLY. THE ELECTRODE MEASUREMENTS WERE OK AND THUS, THE ELECTRODE WAS USED WITH THE NEW DEVICE. THERE WAS NO HARM REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636293 ↗
• MalfunctionMar 14, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CHANGE OUT PROCEDURE THE PHYSICIAN WAS UNABLE TO LOOSEN THE SETSCREW ON THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EVEN AFTER TRYING MULTIPLE WRENCHES. IT WAS NOTED THE NON-TORQUE WRENCH RATCHED BUT DID NOT TURN THE SETSCREW. THE PHYSICIAN WAS CONCERNED THAT THE THREADS WERE JAMMED. AFTER MULTIPLE ATTEMPTS THE PHYSICIAN PUT MINERAL OIL IN AND WAITED FIVE MINUTES. THEN THEY WERE ABLE TO SUCCESSFULLY RETRACT THE SETSCREW AND REMOVE THE TERMINAL PIN. THERE WAS NO DAMAGE TO THE TERMINAL PIN OF THE ELECTRODE, AND IT HAD GOOD SENSING MEASUREMENTS AND WAS ABLE TO REMAIN IMPLANTED WITH THE NEW DEVICE. IT WAS NOTED THE HEADER OF THE EXPLANTED S-ICD WAS DAMAGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539910 ↗
• MalfunctionMar 14, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING THE DEVICE EXPLANT, THE SETSCREW WAS STUCK. THE DOCTOR WAS ABLE TO SUCCESSFULLY UNDO THE SETSCREW AND REPLACE THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539738 ↗
• MalfunctionMar 14, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING THE EXPLANT PROCEDURE, THE SETSCREW WAS STUCK. TECHNICAL SERVICES DISCUSSED TECHNIQUES FOR REMOVAL. THE SETSCREW WAS SUCCESSFULLY UNDONE AND THE DEVICE WAS EXPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539575 ↗
• InjuryMar 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible; Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible

  THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION REGARDING PRODUCT ANALYSIS. THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION THAT THE PRODUCT HAS BEEN EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. IT WAS REPORTED THAT THIS DEVICE EXHIBITED FAULT CODES FOR LONG CHARGE TIMES. THE DEVICE HAS BEEN IMPLANTED GREATER THAN SEVEN YEARS AND HAS 5% BATTERY REMAINING. A REVIEW OF DEVICE DOWNLOADED MEMORY WAS DONE BY TECHNICAL SERVICES AND THE LONG CHARGE TIMES WERE CONFIRMED. THE DEVICE REMAINS IMPLANTED, HOWEVER TECHNICAL SERVICES RECOMMENDED EXPLANT. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536594 ↗
• MalfunctionMar 9, 2023Connection Problem; Connection Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE SYSTEM EXPLANT, THE PHYSICIAN EXPERIENCED DIFFICULTY RELEASING THE HEADER SETSCREW OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). THE LEAD WAS CUT AND BOTH DEVICES WERE SUCCESSFULLY EXPLANTED. THE S-ICD WAS LATER RETURNED FOR LABORATORY ANALYSIS WITH NO RESULTING ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515967 ↗
• MalfunctionMar 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THIS DURING A ROUTINE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) REPLACEMENT, THE PHYSICIAN REPORTED DIFFICULTY RELEASING THE HEADER SETSCREW. THE S-ICD WAS SUCCESSFULLY EXPLANTED. THE DEVICE WAS LATER RETURNED FOR LABORATORY ANALYSIS WITH NO RESULTING ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515352 ↗

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-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