Corox OTW-S 75-BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04035479094157), received between Mar 31, 2016 and Aug 27, 2025 — classified as 17 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025High Capture Threshold; High Capture Threshold

  THIS LV LEAD WAS DEACTIVATED DUE TO CHRONICALLY ELEVATED THRESHOLDS CAUSING PREMATURE ICD ERI. 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 22907224 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTION. THE DEVICE WAS EXPLANTED AND THE LEADS WERE CAPPED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 20592071 ↗
• MalfunctionJun 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577107 ↗
• MalfunctionJun 15, 2023High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  THIS LEAD SHOWS HIGH PACING IMPEDANCE AND NOISE. 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 17135551 ↗
• MalfunctionFeb 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEAD WAS CAPPED DUE TO DISLODGEMENT AND PATIENT THERAPY CHANGE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429853 ↗
• InjuryNov 30, 2022Adverse 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 15886503 ↗
• InjuryJun 22, 2022Adverse 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 14784001 ↗
• InjuryJun 16, 2022Adverse 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 14719374 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14047535 ↗
• MalfunctionMar 10, 2022High Capture Threshold; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO HIGH 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 13726639 ↗
• MalfunctionJan 7, 2022Fracture; Fracture

  THIS LV LEAD WAS EXPLANTED AND REPLACED DUE TO A FRACTURE. 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 13193924 ↗
• MalfunctionAug 26, 2021Break; Break

  THIS LEAD WAS CAPPED BECAUSE THE LEAD FELL APART AT THE HEADER CONNECTION DURING DEVICE CHANGE OUT. UNABLE TO DETACH THE LEAD FROM THE HEADER. 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 12369740 ↗
• MalfunctionAug 12, 2021High Capture Threshold; High Capture Threshold

  LEAD CAPPED DUE TO HIGH THRESHOLDS. 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 12313573 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11802738 ↗
• MalfunctionMar 31, 2021High impedance; Over-Sensing; High impedance; Over-Sensing

  REPORTED OUT OF RANGE IMPEDANCE MEASUREMENTS (>2000 OHMS) ON HOME MONITORING. OUT OF RANGE VALUES WERE NOT REPRODUCED WITH ISOMETRICS AND POSTURAL TESTING IN OFFICE, HOWEVER AN IMPEDANCE RISE OF APPROXIMATELY 300 OHMS WAS OBSERVED WITH THE PATIENT LYING ON THEIR SIDE. OVERSENSING WAS ALSO NOTED. DEVICE WAS PROGRAMMED AAIR IN ORDER TO AVOID USING THIS LEAD PER THE PHYSICIAN. 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 11596750 ↗
• MalfunctionFeb 24, 2021Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO PACING THRESHOLD AND IMPEDANCE INCREASED TO OUT OF RANGE RESULTING IN LOSS OF CAPTURE AT MAX 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 11375751 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11112645 ↗
• InjurySep 14, 2020Adverse 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 10531037 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS REMOVED DUE TO INFECTION ON (B)(6) 2020. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS REPORT WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 10511696 ↗
• MalfunctionJul 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10250049 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFECTION. OP NOTES DOCUMENT DEVICE EXPLANT AND REPLACEMENT, BUT LEADS WERE LEFT ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 10159172 ↗
• MalfunctionJun 8, 2020Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  LEAD WAS EXPLANTED DUE TO HIGH THRESHOLDS AND DISLODGEMENT. 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 10131254 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO EROSION. THERE IS CURRENTLY NO INDICATION THAT A NEW SYSTEM HAS BEEN IMPLANTED. LEAD BROKE DURING EXTRACTION AND WAS PARTIALLY EXPLANTED, BUT IS MOSTLY STILL IN THE BODY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Pocket Erosion

  MAUDE report 9677045 ↗
• MalfunctionFeb 3, 2020Failure to Capture; Failure to Capture

  THIS LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE. 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 9661991 ↗
• MalfunctionDec 4, 2019High Capture Threshold; High Capture Threshold

  HIGH THRESHOLDS WERE REPORTED ON THIS LEAD AND THE RA LEAD. DEVICE BATTERY WAS DEPLETED AFTER 3 1/2 YEARS AND REQUIRED CHANGE OUT DUE TO HIGH THRESHOLDS. PHYSICIAN CHOSE NOT TO CHANGE OUT LEADS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. LEAD REMAINS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9409703 ↗