Selox JT 45 346369Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 04035479077877), received between Jun 27, 2018 and Apr 9, 2026 — classified as 1 death, 22 injuries, 49 malfunctions.

The most frequently reported specific device problem is “High impedance” (17 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. 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Impedance Problem

  THIS RA LEAD WAS CAPPED DUE TO OUT OF RANGE IMPEDANCE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831075 ↗
• InjuryMar 26, 2026Device Sensing Problem

  THE RA LEAD WAS EXPLANTED DUE TO POOR SENSING AFTER THE RV LEAD WAS REMOVED. 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 24707183 ↗
• InjuryOct 16, 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 23317418 ↗
• MalfunctionMar 25, 2025Failure to Capture; Failure to Capture

  THIS LEAD WAS CAPPED DUE TO LOSS OF CAPTURE. 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 21690213 ↗
• MalfunctionSep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327331 ↗
• MalfunctionJul 11, 2024Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  THIS LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE DUE TO DISLODGEMENT FOLLOWING FALL. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726638 ↗
• MalfunctionApr 25, 2024Ambient Noise Problem; Ambient Noise Problem

  RA LEAD HAS WHAT APPEARS TO BE INTERMITTENT NOISE, MOST RECENTLY NOTED ON THE PERIODIC IEGM DATED (B)(6) 2024. PATIENT TO BE BROUGHT IN FOR POSTURAL AND ISOMETRIC TESTING. LEAD REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188127 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 18498487 ↗
• MalfunctionNov 3, 2023High impedance; High impedance

  LEAD WAS EXPLANTED DUE TO TRENDING HIGH IMPEDANCE. 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 18069764 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD WAS EXPLANTED DUE TO LEAD ON LEAD BINDING. DURING THE EXTRACTION OF THIS RA LEAD, AN SVC TEAR OCCURRED RESULTING IN THE PT NEEDING IMMEDIATE SURGERY TO FIX. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Great Vessel Perforation

  MAUDE report 18058662 ↗
• MalfunctionJul 12, 2023Unstable Capture Threshold; Unstable Capture Threshold

  THIS RA LEAD WAS EXPLANTED DUE TO INCREASING THRESHOLD. 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 17305357 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16684683 ↗
• MalfunctionMar 1, 2023Ambient Noise Problem; Impedance Problem; Ambient Noise Problem; Impedance Problem

  LEAD WAS CAPPED DUE TO OUT OF RANGE PACING IMPEDANCE AND NOISE. 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 16464893 ↗
• MalfunctionDec 30, 2022Break; High impedance; High Capture Threshold; Break; High impedance; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO POSSIBLE INSULATION BREACH, HIGH IMPEDANCE AND THRESHOLD. 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 16078241 ↗
• MalfunctionOct 31, 2022High Capture Threshold; High Capture Threshold

  LEAD WAS CAPPED DUE TO INCREASED HIGH ATRIAL THRESHOLD. 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 15699465 ↗
• MalfunctionOct 13, 2022High impedance; High impedance

  THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCE. 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 15595705 ↗
• MalfunctionJul 1, 2022Under-Sensing; Unstable Capture Threshold; Under-Sensing; Unstable Capture Threshold

  THIS LEAD WAS CAPPED DUE TO LOW SENSING AND INCREASED THRESHOLD. 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 14885426 ↗
• MalfunctionJun 28, 2022Fracture; Fracture

  THIS LEAD WAS CAPPED DUE TO LEAD FRACTURE. 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 14847681 ↗
• MalfunctionApr 7, 2022High impedance; Device Sensing Problem; High impedance; Device Sensing Problem

  THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCES AND LOW SENSING. 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 14047547 ↗
• MalfunctionMar 17, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

  LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCE AND HIGH THRESHOLD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795926 ↗
• MalfunctionJan 7, 2022Failure to Sense; Failure to Sense

  THIS RA LEAD HAS NOT BEEN SENSING AND SO WAS CAPPED AND REPLACED. 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 13193934 ↗
• MalfunctionNov 11, 2021High impedance; High impedance

  LEAD IMPEDANCE OUT OF RANGE, GREATER THAN 3000 OHMS. LEAD WAS CAPPED. 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 12796364 ↗
• MalfunctionOct 14, 2021High impedance; High Capture Threshold; High impedance; High Capture Threshold

  LEAD CAPPED DUE TO HIGH IMPEDANCE AND HIGH THRESHOLD. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636536 ↗
• MalfunctionAug 23, 2021Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  LEAD CAPPED DUE TO LOSS OF CAPTURE CAUSED BY DISLODGEMENT. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12357030 ↗
• MalfunctionAug 18, 2021Failure to Capture; Failure to Capture

  LEAD CAPPED DUE TO TWIDDLERS SYNDROME. THIS LEAD WAS ORIGINALLY PULLED OUT BY THE PATIENT LEADING TO NON-CAPTURE. DUE TO THE OCCLUSION OF THE VEINS ON THE LEFT SIDE HOWEVER, THE PHYSICIAN CHOSE TO CAP THE LEAD AND ABANDON THE SYSTEM ON THE LEFT SIDE IN FAVOR OF A COMPETITOR SYSTEM ON THE RIGHT SIDE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: Twiddlers Syndrome

  MAUDE report 12339438 ↗