Corox OTW-L 85-BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 04035479112172), received between Jul 2, 2018 and Aug 19, 2025 — classified as 27 injuries, 46 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (16 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 73 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 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 22844225 ↗
• MalfunctionAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742549 ↗
• MalfunctionJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS 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 22578001 ↗
• InjuryMar 26, 2024Adverse 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 18977721 ↗
• MalfunctionMar 18, 2024High Capture Threshold; High Capture Threshold

  THIS LEAD SHOWS HIGH THRESHOLDS. PATIENT WAS BROUGHT IN TO ATTEMPT PLACING A LBB LEAD, BUT DUE TO SUBCLAVIAN STENOSIS, CASE WAS ABORTED. CONSIDERING PATIENT AGE AND POOR STATUS, PHYSICIAN DECIDED TO CHANGE OUT THE DEVICE ONLY. 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 18920420 ↗
• MalfunctionSep 27, 2023Failure to Capture; High impedance; Failure to Capture; High impedance

  THIS LV LEAD WAS CAPPED DUE TO NO CAPTURE AT MAXIMUM OUTPUT AND 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 17828897 ↗
• MalfunctionSep 27, 2023Failure to Capture; Device Sensing Problem; Failure to Capture; Device Sensing Problem

  THIS LV LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE AND SENSING. 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 17825430 ↗
• InjuryFeb 6, 2023Fracture; Fracture

  THIS LV LEAD WAS IN THE PROCESS OF BEING EXPLANTED FOR A QUADRIPOLAR LEAD IN ORDER TO ELIMINATE DIAPHRAGMATIC STIMULATION WHEN IT FRACTURED. DURING THIS, THE PATIENT STARTED TO BLEED AND PART OF THE LEAD REMAINED IN THE PATIENT. THE PATIENT WAS TAKEN TO CARDIAC SURGERY FOR THE BLEED AND THERE MAY HAVE BEEN A PERFORATION. THE SURGERY WAS SUCCESSFUL. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Cardiac Perforation; Device Embedded In Tissue or Plaque; Undesired Nerve Stimulation

  MAUDE report 16308258 ↗
• MalfunctionDec 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEAD EXPLANTED DUE TO IT HAD CHRONICALLY DISLODGED INTO THE SVC. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16065003 ↗
• MalfunctionNov 29, 2022Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold; Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold

  LEAD WAS CAPPED DUE TO INCREASED THRESHOLDS WITH DECREASING SENSING CAUSED BY DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877089 ↗
• MalfunctionNov 3, 2022Extracardiac stimulation; Extracardiac stimulation

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

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 15723069 ↗
• MalfunctionNov 2, 2022Failure to Capture; Failure to Capture

  LEAD WAS CAPPED DUE TO 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 15713794 ↗
• InjurySep 14, 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 15417988 ↗
• MalfunctionSep 8, 2022High Capture Threshold; High Capture Threshold

  THIS LEAD WAS EXPLANTED DUE TO HIGH PACING 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 15385189 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14706936 ↗
• InjuryJun 15, 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 14703836 ↗
• MalfunctionApr 29, 2022Failure to Capture; Failure to Capture

  LEAD WAS CAPPED DUE TO LOSS OF 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 14254937 ↗
• InjuryApr 21, 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 14172246 ↗
• MalfunctionMar 10, 2022Failure 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13726781 ↗
• MalfunctionMar 8, 2022High Capture Threshold; High Capture Threshold

  LEAD EXPLANTED 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 13692936 ↗
• MalfunctionMar 1, 2022Malposition of Device; Malposition of Device

  THIS LV LEAD WAS CAPPED AND REPLACED BECAUSE THE PHYSICIAN FELT LIKE IT WAS IN A BAD POSITION. THE PHYSICIAN IMPLANTED A NEW IS4 LV LEAD. 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 13637490 ↗
• MalfunctionJan 19, 2022Failure to Capture; High impedance; Failure to Capture; High impedance

  LEAD WAS SHOWING HIGH IMPEDANCES OF GREATER THAN 3000 OHMS VIA HOME MONITORING IN (B)(6) 2018. SINCE THEN IT HAS EXHIBITED INTERMITTENT NON-CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. 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 13288748 ↗
• MalfunctionJan 12, 2022Failure to Capture; Extracardiac stimulation; Failure to Capture; Extracardiac stimulation

  LOSS OF CAPTURE SEEN IN PERIODIC IEGM. PATIENT WILL BE BROUGHT IN TO EVALUATE THRESHOLDS. DIAPHRAGMATIC STIMULATION WAS SEEN DURING PREVIOUS FOLLOW UPS BUT TROUBLESHOOTING WILL BE DONE IN OFFICE. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 13239999 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 13226313 ↗
• MalfunctionJan 4, 2022Malposition of Device; High Capture Threshold; Malposition of Device; High Capture Threshold

  THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH THRESHOLDS AND A BAD POSITION. 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 13154742 ↗