Corox OTW 75-BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04035479093532), received between May 16, 2019 and Apr 14, 2022 — classified as 1 death, 2 injuries, 10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2022High Capture Threshold; High Capture Threshold

  THIS LEAD IS SHOWING HIGH THRESHOLDS. A CHANGE OUT WAS ATTEMPTED, BUT PHYSICIAN WAS UNABLE TO GAIN ACCESS. 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 14116182 ↗
• MalfunctionFeb 21, 2022Failure to Capture; Failure to Capture

  THIS LV 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 13571645 ↗
• MalfunctionJan 11, 2022Ambient Noise Problem; Ambient Noise Problem

  NOISE HAS BEEN REPORTED ON THIS LV LEAD. THE LEAD CURRENTLY REMAINS 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 13226277 ↗
• DeathJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12210358 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12189195 ↗
• InjuryApr 21, 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 11700624 ↗
• MalfunctionMar 30, 2021Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  LEAD EXPLANTED DUE TO INCREASINGLY HIGH THRESHOLDS AND LOSS OF 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 11590888 ↗
• MalfunctionOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RV LEAD LINOX S 65 SHOWED SIGNS OF FAILURE ALREADY IN 2018 AND WAS PROGRAMMED OFF THEN. THE LV LEAD COROX OTW 75-BP SHOWED SIGNS OF FAILURE IN THE RECENT PAST. THE DECISION WAS MADE TO EXPLANT BOTH LEADS. NO BIOTRONIK REP WAS PRESENT DURING THIS PROCESS. VERY LIMITED INFORMATION HAS BEEN TRANSFERRED ON THIS CASE SO FAR. THE ESTIMATED IMPLANTATION PERIOD OF BOTH LEADS WAS 140 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10766819 ↗
• MalfunctionOct 8, 2020Ambient Noise Problem; Ambient Noise Problem

  LEAD APPEARS TO HAVE NOISE. UNABLE TO SEE FF TO CONFIRM IF LEAD OR EXTERNAL. COMPLETE LEAD EVALUATION RECOMMENDED. 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 10652609 ↗
• MalfunctionOct 22, 2019Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS LV LEAD FAILED TO CAPTURE. THE LEAD APPEARS TO REMAIN IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9221568 ↗
• MalfunctionOct 14, 2019High Capture Threshold; High Capture Threshold

  LV LEAD SHOWS HIGH THRESHOLDS AND IS PROGRAMMED TO 6.5V AT 1.0MS. 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 9187453 ↗
• MalfunctionJul 18, 2019High Capture Threshold; High Capture Threshold

  THIS LV LEAD WAS EXPLANTED DUE TO HIGH THRESHOLDS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8803743 ↗
• MalfunctionMay 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS LV LEAD WAS CAPPED DUE TO 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 8616828 ↗