Corox OTW 85-BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04035479093549), received between Mar 17, 2019 and Jan 13, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Failure to Capture; High impedance

  THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCE AND NO CAPTURE THRESHOLD. 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 24058541 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LEAD WAS PARTIALLY EXPLANTED ON (B)(6) 2023 DUE TO INFECTION, SURGEON WAS UNABLE TO REMOVE DISTAL END OUT OF FAR END OF CS BRANCH DURING OPEN HEART SURGERY FIVE DAYS AFTER ICD REMOVAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Device Embedded In Tissue or Plaque; Unspecified Infection

  MAUDE report 17979790 ↗
• MalfunctionOct 5, 2023Device 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 17876830 ↗
• MalfunctionMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LV LEAD WAS EXPLANTED DUE TO PHRENIC NERVE STIMULATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 13637494 ↗
• MalfunctionJun 25, 2021Intermittent Capture; Intermittent Capture

  LEAD CAPPED DUE TO INTERMITTENT CAPTURE AT MAX OUTPUT. 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 12065970 ↗
• MalfunctionMay 18, 2021Extracardiac stimulation; High Capture Threshold; Extracardiac stimulation; High Capture Threshold

  THIS LV LEAD WAS EXPLANTED DUE TO HIGH THRESHOLDS AND POCKET STIMULATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11842056 ↗
• MalfunctionApr 15, 2021Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  LEAD REMAINS IMPLANTED. REPRESENTATIVE REPORTED OVERSENSING ON THE LV CHANNEL. LV IEGM IS NOT VISIBLE ON TRANSMITTED RECORDINGS, HOWEVER THE SECOND LVS EVENT APPEARS TO LINE UP WITH THE T-WAVE ON THE FAR-FIELD CHANNEL. LOSS OF CAPTURE WAS ALSO REPORTED. LEAD TO BE EVALUATED FURTHER. 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 11675803 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11091954 ↗
• MalfunctionOct 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ERI DEVICE CHANGE OUT IT WAS NOTED THAT THE LV LEAD HAD DISLODGED INTO THE RA. THIS WAS NOTED ON X-RAYS DATED 2017 (UNAVAILABLE). PHYSICIAN CUT LEAD AND TIED OFF END. 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 10690441 ↗
• MalfunctionOct 1, 2020Ambient 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 10612308 ↗
• MalfunctionJun 2, 2020Pacing Problem; Material Integrity Problem; Pacing Problem; Material Integrity Problem

  IT WAS REPORTED THAT INTRINSIC LV EVENTS FALLING INTO A REFRACTORY PERIOD FOLLOWED BY PACING ON THE LV CHANNEL WERE OBSERVED. PATIENT LATER NEEDED RV LEAD REVISION; IN THE COURSE OF LASER EXTRACTION OF RV LEAD, THIS LEAD WAS DAMAGED AND ULTIMATELY EXPLANTED. 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 10112845 ↗
• MalfunctionApr 13, 2020High Capture Threshold; High Capture Threshold

  THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH THRESHOLDS. 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 9955036 ↗
• MalfunctionJan 22, 2020Failure to Capture; Device Sensing Problem; Failure to Capture; Device Sensing Problem

  THIS LEAD WAS CAPPED AND REPLACED DUE TO SENSING ISSUES AND 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 9617916 ↗
• InjuryJan 16, 2020Adverse 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) 2020. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 9599280 ↗
• MalfunctionJan 6, 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 9555763 ↗
• MalfunctionAug 14, 2019High impedance; High impedance

  THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCE OVER 3000OHMS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8895470 ↗
• MalfunctionJul 11, 2019Intermittent Capture; High Capture Threshold; Intermittent Capture; High Capture Threshold

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781186 ↗
• MalfunctionApr 16, 2019Break; High Capture Threshold; Break; High Capture Threshold

  DURING A GEN CHANGE LV LEAD INSULATION WAS FOUND TO HAVE A BREACH NEAR THE PIN. LEAD WAS CAPPED AND REMAINS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520861 ↗
• MalfunctionMar 17, 2019High impedance; High impedance

  THIS LEAD WAS CAPPED AND REPLACED DUE TO IMPEDANCES OF GREATER THAN 3000 OHMS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8427300 ↗