Setrox S 60 350975Recalls & reported problems

Summary

The FDA's MAUDE database contains 347 adverse event reports that list this exact device (DI 04035479087968), received between Jun 15, 2018 and Sep 17, 2026 — classified as 110 injuries, 237 malfunctions.

The most frequently reported specific device problem is “Ambient Noise Problem” (77 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 347 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Sepsis

  MAUDE report 50811930 ↗
• InjurySep 15, 2026Failure to Capture; High impedance

  RV lead was capped due to high impedance and no capture at max output. No adverse patient events were reported. Should additional information be received this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779018 ↗
• InjurySep 11, 2026Device Dislodged or Dislocated

  This lead was explanted due to it dislodged while the RA lead was being removed. Should additional information be received, this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734315 ↗
• InjurySep 9, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680730 ↗
• InjurySep 2, 2026Low impedance; Ambient Noise Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576305 ↗
• MalfunctionAug 13, 2026Ambient Noise Problem

  RV lead failure was detected on (b)(6) 2026. Review of the bipolar RV lead failure episode IEGM demonstrated noise on the RV channel. The lead remains implanted at this time. No adverse patient events were reported. Should additional information be received, this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234275 ↗
• MalfunctionMay 5, 2026Ambient Noise Problem

  NOISE WAS SEEN ON THE RV CHANNEL IN RECORDINGS STORED ON THE DEVICE. LEAD IS CURRENTLY IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087196 ↗
• MalfunctionDec 31, 2025Impedance Problem; Impedance Problem

  THIS LEAD WAS CAPPED DUE TO IMPEDANCE OUT OF RANGE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935963 ↗
• MalfunctionDec 17, 2025Failure to Capture; Failure to Capture

  DURING GEN CHANGE, THIS LEAD WAS CAPPED DUE TO INTERMITTENT LOSS OF CAPTURE WHILE ON PSA. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829758 ↗
• MalfunctionDec 5, 2025Fracture; High impedance; Over-Sensing; Fracture; High impedance; Over-Sensing

  THIS RV PACE/SENSE LEAD WAS CAPPED DUE TO FRACTURE WITH PT SYNCOPE DUE TO OVERSENSING, AND IMPEDANCE OF NEARLY 3000 OHMS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Syncope/Fainting

  MAUDE report 23728496 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING LEAD REVISION AN INFECTION WAS FOUND AND SYSTEM WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 23509795 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 22846922 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 22794291 ↗
• MalfunctionAug 4, 2025High Capture Threshold; High Capture Threshold

  THIS RV LEAD WAS CAPPED DUE TO HIGH PACING CAPTURE THRESHOLD WITH SIGNIFICANT RV PACING BURDEN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699336 ↗
• MalfunctionJul 31, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  LEAD HAD HIGH IMPEDANCE AND THRESHOLD. IT WAS CAPPED AND PARTIALLY EXTRACTED (TIP REMAINS IN PATIENT). SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22680544 ↗
• MalfunctionJul 16, 2025Intermittent Capture; Intermittent Capture

  THIS RV LEAD WAS EXPLANTED DUE TO INTERMITTENT LOSS OF PACING CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22525015 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO BACTEREMIA, ENDOCARDITIS, AND A SPINAL ABSCESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Abscess; Bacteremia; Endocarditis

  MAUDE report 22350253 ↗
• MalfunctionJun 11, 2025Pacing Intermittently; Ambient Noise Problem; Pacing Intermittently; Ambient Noise Problem

  RV LEAD WAS EXPLANTED DUE TO NOISE CAUSING INHIBITION OF PACING LEADING TO DIZZY SPELLS ON A DEPENDENT PATIENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Dizziness

  MAUDE report 22190148 ↗
• MalfunctionJun 4, 2025Failure to Capture; High impedance; Device Sensing Problem; Failure to Capture; High impedance; Device Sensing Problem

  THIS LEAD WAS CAPPED DUE TO >3,000 OHM IMPEDANCE, NO SENSING, AND NO CAPTURE AT MAXIMUM OUTPUT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145588 ↗
• MalfunctionMay 9, 2025Failure to Capture; Failure to Capture

  LEAD WAS CAPPED DUE TO NON-CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996184 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Endocarditis

  MAUDE report 21510756 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 21354225 ↗
• MalfunctionFeb 3, 2025Low impedance; Ambient Noise Problem; Low impedance; Ambient Noise Problem

  THIS LEAD WAS CAPPED DUE TO NOISE AND LOW IMPEDANCE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300446 ↗
• MalfunctionFeb 3, 2025High Capture Threshold; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO HIGH THRESHOLD. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296437 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 21224642 ↗