Selox ST 53 346366Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 04035479077846), received between Jun 21, 2018 and Jul 22, 2025 — classified as 16 injuries, 90 malfunctions.

The most frequently reported specific device problem is “High impedance” (33 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Failure to Capture; Failure to Capture

  THIS LEAD WAS CAPPED DUE TO FAILURE TO 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 22566721 ↗
• MalfunctionMay 23, 2025Fracture; High impedance; Fracture; High impedance

  FRACTURED LEAD WITH IMPEDANCE GREATER THAN 2500 OHMS WAS EXPLANTED AND REPLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077867 ↗
• MalfunctionMar 5, 2025High Capture Threshold; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528466 ↗
• MalfunctionSep 27, 2024High impedance; High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317962 ↗
• MalfunctionJul 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726343 ↗
• MalfunctionOct 3, 2023High impedance; High impedance

  THIS RV LEAD WAS CAPPED AND REPLACED DUE TO HIGH IMPEDANCES. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHB AND UNDERLYING RHYTHM IN THE 30S. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861039 ↗
• MalfunctionAug 14, 2023Failure to Capture; Fracture; Failure to Capture; Fracture

  LEAD WAS EXPLANTED DUE TO FRACTURE AND NON CAPTURE. 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 17541771 ↗
• MalfunctionJun 20, 2023Failure to Capture; Fracture; Failure to Capture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162684 ↗
• MalfunctionDec 14, 2022High Capture Threshold; High Capture Threshold

  LEAD WAS CAPPED DUE TO HIGH THRESHOLDS. 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 15976458 ↗
• InjuryAug 7, 2022Failure to Capture; Failure to Capture

  INTERMITTENT LOSS OF CAPTURE ON TELEMETRY WITH HIGH OUTPUTS PROGRAMMED ON THE RV CHANNEL WERE REPORTED. PATIENT WAS SEEN IN THE ER ON (B)(6) 2022 DUE TO SYNCOPE AND THE OUTPUT WAS INCREASED TO 3.5V AT 1.5 MS AT THAT TIME. IMPEDANCE AND SENSING TRENDS WERE UNREMARKABLE. LEAD TO BE EVALUATED FURTHER AND REMAINS IMPLANTED.

  Patient problems: Syncope/Fainting

  MAUDE report 15180783 ↗
• MalfunctionAug 2, 2022Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  THIS LEAD WAS CAPPED DUE TO LEAD FRACTURE, IMPEDANCE GREATER THAN 2500 OHMS AND NO CAPTURE AT MAX OUTPUT UNIPOLAR AND BIPOLAR. 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 15153607 ↗
• MalfunctionJul 28, 2022High impedance; High impedance

  THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCES, GREATER THAN 2500 OHMS. 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 15126786 ↗
• MalfunctionJun 28, 2022Failure to Capture; Failure to Capture

  THIS LEAD WAS CAPPED DUE TO LOSS OF CAPTURE AT MAXIMUM OUTPUT. 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 14847595 ↗
• InjuryApr 22, 2022Adverse 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 14188218 ↗
• MalfunctionApr 21, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCES AND THRESHOLDS. 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 14172360 ↗
• InjuryApr 13, 2022Adverse 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 14103664 ↗
• MalfunctionJan 21, 2022Fracture; High Capture Threshold; Fracture; High Capture Threshold

  THIS LEAD WAS EXPLANTED AND REPLACED DUE TO CONDUCTOR FRACTURE, BIPOLAR THRESHOLD 6.0V @ 1.5MS, UNIPOLAR 4.0V @ 1.0MS. 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 13314274 ↗
• MalfunctionJan 12, 2022Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  THIS LEAD WAS CAPPED AND REPLACED DUE TO AN INCREASE IN LEAD IMPEDANCES AND IN THRESHOLDS. 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 13239549 ↗
• MalfunctionDec 20, 2021High Capture Threshold; High Capture Threshold

  LEAD EXPLANTED DUE TO ELEVATED RV 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 13044378 ↗
• MalfunctionNov 9, 2021Ambient Noise Problem; Ambient Noise Problem

  THIS LEAD WAS CAPPED DUE TO NOISE. 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 12782957 ↗
• MalfunctionOct 13, 2021Ambient Noise Problem; Impedance Problem; Ambient Noise Problem; Impedance Problem

  HIGH FREQUENCY NOISE AND BIPOLAR LEAD FAILURE ALERT ON HMSC. RECOMMENDED DISCUSSING WITH PATIENT ANY SOURCES OF EXTERNAL NOISE AND EVALUATING LEAD IN PERSON. DEVICE REMAINS IMPLANTED. 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 12624263 ↗
• MalfunctionSep 27, 2021Fracture; High impedance; Fracture; High impedance

  LEAD FRACTURE. IMPEDANCE MEASURED GREATER THAN 2500 OHMS ON BOTH UNI/BIPOLAR. LEAD WAS CAPPED. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12534572 ↗
• MalfunctionSep 27, 2021High impedance; High Capture Threshold; High impedance; High Capture Threshold

  LEAD CAPPED DUE TO ACUTE RISE IN THRESHOLD AND PACING IMPEDANCE. IMPEDANCE ROSE TO 2,145 OHMS FROM 624 OHMS AT LAST FOLLOW UP. CAPTURE THRESHOLD WENT FROM 2.2V AT 0.4MS LAST FOLLOW UP, TO 6V AT 0.4MS. 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 12533908 ↗
• MalfunctionSep 21, 2021Failure to Capture; Over-Sensing; Low impedance; Ambient Noise Problem; Failure to Capture; Over-Sensing; Low impedance; Ambient Noise Problem

  NOISE ON LEAD. LEAD CHECK FLIPPED TO UNIPOLAR DUE TO LOW IMPEDANCE. LEAD REMAINS IMPLANTED. 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 12510031 ↗
• MalfunctionAug 16, 2021Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  RV LEAD CAPPED DUE TO POSSIBLE FRACTURE. LEAD HAD IMPEDANCE GREATER THAN 2500 BIPOLAR/UNIPOLAR AND NON CAPTURE. 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 12328884 ↗