Selox JT 53 346368Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04035479077860), received between Dec 21, 2018 and Mar 26, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “High impedance” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026High impedance; Device Sensing Problem; High Capture Threshold

  RA LEAD WAS EXPLANTED DUE TO IMPEDANCE HIGH, HIGH THRESHOLD AND LOW SENSING. 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 24706920 ↗
• InjuryMar 12, 2026Break

  THIS LEAD WAS CAPPED DUE TO LEAD BREAK. 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 24579348 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 19152003 ↗
• MalfunctionNov 11, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THIS LEAD WAS CAPPED DUE TO SUB-CLAVICLE CRUSH. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777972 ↗
• MalfunctionJan 13, 2022Fracture; Patient Device Interaction Problem; Fracture; Patient Device Interaction Problem

  THIS LEAD WAS FRACTURED DUE TO SUBCLAVIAN CRUSH. PROXIMAL PORTION OF THE LEAD WAS EXPLANTED. THE DISTAL PORTION REMAINS 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 13251318 ↗
• MalfunctionNov 1, 2021High impedance; High impedance

  LEAD CAPPED DUE TO LEAD IMPEDANCE GREATER THAN 2500 OHMS. 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 12728036 ↗
• MalfunctionSep 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED AND DISCARDED DUE TO MALFUNCTION APPROX. 131 MONTHS AFTER THE IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413421 ↗
• MalfunctionJul 14, 2021Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  THIS LEAD WAS ORIGINALLY CAPPED IN (B)(6) 2021 DUE TO HIGH THRESHOLDS AND DISLODGEMENT AND LATER EXPLANTED ON (B)(6) 2021 DURING NEW SYSTEM IMPLANT. 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 12167754 ↗
• MalfunctionJun 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO FRACTURE APPROX. 67 MONTHS AFTER THE IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081307 ↗
• MalfunctionJun 10, 2021Fracture; Fracture

  THIS LEAD WAS CAPPED DUE TO 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 11979951 ↗
• MalfunctionMar 31, 2021Break; Break

  THIS LEAD WAS CAPPED DUE TO LEAD SEPARATED AT PIN WHEN REMOVED FROM DEVICE DURING CHANGEOUT. 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 11596708 ↗
• MalfunctionMay 14, 2020Over-Sensing; Over-Sensing

  THIS LEAD WAS CAPPED DUE TO OVERSENSING, NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10056022 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. AN SR-T DEVICE WAS IMPLANTED ON THE SAME DAY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 9251114 ↗
• MalfunctionOct 28, 2019Break; Break

  THIS LEAD WAS CAPPED DUE TO AN INSULATION ISSUE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9246542 ↗
• MalfunctionOct 22, 2019Failure to Capture; High impedance; Failure to Capture; High impedance

  THIS LEAD WAS CAPPED AND REPLACED DUE TO LOSS OF CAPTURE AND IMPEDANCES OVER 2000 OHMS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9221600 ↗
• MalfunctionSep 27, 2019High impedance; High impedance

  THIS LEAD WAS CAPPED DUE TO IMPEDANCES GREATER THAN 2000 OHMS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131653 ↗
• MalfunctionSep 24, 2019Naturally Worn; Naturally Worn

  THIS ATRIAL LEAD WAS CAPPED DURING A SYSTEM EXPLANT DUE TO SUSPECTED SUBCLAVIAN CRUSH. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109610 ↗
• MalfunctionAug 27, 2019Ambient Noise Problem; Ambient Noise Problem

  THIS LEAD WAS CAPPED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8937738 ↗
• MalfunctionJun 7, 2019High impedance; High Capture Threshold; High impedance; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO HIGH THRESHOLDS AND HIGH PACING IMPEDANCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8680599 ↗
• MalfunctionFeb 22, 2019Failure to Capture; High impedance; Failure to Capture; High impedance

  THIS LEAD WAS CAPPED AND REPLACED DUE TO LOSS OF CAPTURE AND HIGH IMPEDANCES. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361991 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS IMPLANTED (B)(6) 2018. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 8191177 ↗