Corox OTW-S 85-BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 04035479094164), received between Jun 18, 2018 and May 21, 2026 — classified as 12 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (9 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Failure to Capture; High impedance

  LV LEAD WAS CAPPED DUE TO IMPEDANCE >3000 OHMS 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 25245783 ↗
• MalfunctionMay 28, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO HIGH THRESHOLD AND HIGH LEAD IMPEDANCE ( >3000 OHMS). SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095489 ↗
• InjuryAug 7, 2024Adverse 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 19927721 ↗
• MalfunctionMay 22, 2024Failure to Capture; Ambient Noise Problem; Device Sensing Problem; Impedance Problem; Failure to Capture; Ambient Noise Problem; Device Sensing Problem; Impedance Problem

  THIS LEAD WAS CAPPED DUE TO APPARENT NOISE AND UNIPOLAR LEAD FAILURE. LEAD TRENDS SHOW DECREASED SENSING AND SUDDEN CHANGE IN LEAD IMPEDANCE. 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 19373185 ↗
• MalfunctionNov 9, 2023Extracardiac stimulation; Extracardiac stimulation

  LEAD WAS DEACTIVATED. THERE WAS INAPPROPRIATE DIAPHRAGMIC STIMULATION. PROGRAMMING FAILED TO CORRECT THE UNWANTED STIMULATION AND ATTEMPT TO ACCESS SUBCLAVIAN VEIN WAS UNSUCCESSFUL SO LEAD WAS DEACTIVATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 18107562 ↗
• MalfunctionFeb 21, 2023Ambient Noise Problem; Impedance Problem; Ambient Noise Problem; Impedance Problem

  THIS LEAD SHOWS IMPEDANCE ISSUES AND NOISE. LEAD TO BE EVALUATED AND 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 16414427 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS EXPERIENCING DISCOMFORT, DIZZINESS, AND PALPITATIONS DURING BIV PACING. LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Discomfort; Dizziness

  MAUDE report 15417987 ↗
• MalfunctionJun 9, 2022Ambient Noise Problem; Ambient Noise Problem

  (B)(6) 2022, NOISE WAS OBSERVED TO THE LV LEAD AND RV LEAD. (B)(6), LV LEAD WAS EXPLANTED AND ADDITIONAL LV LEAD WAS 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 14642766 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14516211 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pocket Erosion

  MAUDE report 13641430 ↗
• MalfunctionNov 9, 2021High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  HIGH IMPEDANCE WAS REPORTED ON THIS LEAD BEGINNING ON (B)(6) 2020. ON (B)(6) 2021, HIGH IMPEDANCE AND NOISE WAS REPORTED ON THE LV CHANNEL. LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783325 ↗
• MalfunctionOct 29, 2021Naturally Worn; Naturally Worn

  LEAD CAPPED DUE TO SUBCLAVIAN CRUSH. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721072 ↗
• InjuryOct 29, 2021Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  LEAD EXPLANTED DURING POCKET REVISION DUE TO POCKET EROSION. LEAD ALSO HAD AN ELECTRICAL ISSUE DURING EXPLANT CAUSING THE FIRST NEW ICD ATTEMPTING TO BE IMPLANTED TO SHORT CIRCUIT AND NEED TO BE REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: Pocket Erosion

  MAUDE report 12721049 ↗
• MalfunctionOct 13, 2021Ambient Noise Problem; Ambient Noise Problem

  NOISE DETECTED ON HM IEGMS AND REPRODUCIBLE IN OFFICE FOLLOW UP. DEVICE AND LEADS REMAIN 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 12624232 ↗
• MalfunctionMay 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790705 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD WAS CAPPED DUE TO POCKET SWELLING AND PAIN CAUSED BY A LARGE CYST ON THE ROOF OF THE INFERIOR PORTION OF THE POCKET. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: Cyst(s); Implant Pain; Swelling/ Edema

  MAUDE report 11757654 ↗
• MalfunctionJan 28, 2021Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  DURING A DEVICE CHANGE OUT, IT WAS NOTED THAT THE LV LEAD HAD NO CAPTURE AND THRESHOLDS OF OVER 5 VOLTS. THE PATIENT WAS OCCLUDED AND THIS LEAD WAS LEFT IN AND REMAINS ACTIVELY IMPLANTED. NO ADVERSE EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243331 ↗
• MalfunctionNov 19, 2020Over-Sensing; Low impedance; High Capture Threshold; Over-Sensing; Low impedance; High Capture Threshold

  OVERSENSING AND LOW IMPEDANCE WAS RECORDED. THIS LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10868410 ↗
• MalfunctionNov 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10845852 ↗
• MalfunctionOct 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS REPORT WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10667425 ↗
• MalfunctionSep 10, 2020Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  LV LEAD HAD IMPEDANCE OVER 2500 OHMS WITH NO CAPTURE. 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 10513685 ↗
• MalfunctionMay 28, 2020Ambient Noise Problem; Ambient Noise Problem

  NOISE WAS REPORTED ON THIS LEAD. LEAD REMAINS IMPLANTED. 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 10099340 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE IS CURRENTLY NO INDICATION THAT A NEW SYSTEM HAS BEEN IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 9949276 ↗
• MalfunctionMar 19, 2020High Capture Threshold; High Capture Threshold

  THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH THRESHOLD. 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 9853159 ↗
• MalfunctionFeb 5, 2020Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  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 Known Impact Or Consequence To Patient

  MAUDE report 9672643 ↗