SQ-RX PULSE GENERATORRecalls & reported problems across all models

We found 2 models of SQ-RX PULSE GENERATOR by Cameron Health, Inc. in the FDA's device registry (GUDID). Together they are named in 858 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2014 and Aug 19, 2026 — classified as 6 deaths, 520 injuries, 332 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (189 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SQ-RX PULSE GENERATOR problems

SQ-RX PULSE GENERATOR models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SQ-RX® PULSE GENERATOR 1010

  Implantable cardioverter defibrillator (non-CRT)
  3 deaths596 reports
• SQ-RX® PULSE GENERATOR 1010

  Implantable cardioverter defibrillator (non-CRT)
  3 deaths262 reports

Recent SQ-RX PULSE GENERATOR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Battery Problem

  It was reported that the device battery had reached end of life back in 2022. The device had been implanted greater than eight years. It was decided to leave the pulse generator implanted. Recently, the patient wanted the system explanted. The entire system was explanted successfully. The condition of the patient had improved so no replacement was done. There were no additional adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324073 ↗
• 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 ↗
• MalfunctionMar 26, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) HAS BEEN BEEPING FOR OVER ONE YEAR. THE BATTERY IS AT END-OF-LIFE AFTER OVER NINE YEARS OF IMPLANT TIME. TECHNICAL SERVICES DISCUSSED THE BEEPING WITH THE NURSE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977528 ↗
• 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 ↗