Corox OTW-L 75-BPRecalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
All models of Corox (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Corox OTW-BP is an implanted drug-eluting wire that paces the heart's left ventricle. The 31 reports mostly describe leads that stopped working properly — a fractured or capped lead, noise on the recordings, a high pacing threshold, or the wire moving out of position — and several leads being removed because of infection or unwanted stimulation of the phrenic nerve. Twelve reports describe injuries and none describe deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04035479112165), received between Mar 26, 2019 and Apr 21, 2026 — classified as 12 injuries, 19 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (5 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- High Capture Threshold5
- Ambient Noise Problem3
- Extracardiac stimulation3
- High impedance3
- Break2
- Device Dislodged or Dislocated2
- Failure to Capture1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Undesired Nerve Stimulation7
- Unspecified Infection7
- No Known Impact Or Consequence To Patient6
- Endocarditis1
- Muscle Stimulation1
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Fracture
LEAD WAS CAPPED DUE TO 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 24947639 ↗MalfunctionSep 15, 2025Extracardiac stimulation; Extracardiac stimulation
THIS LEAD WAS CAPPED DUE TO CHRONIC PHRENIC NERVE STIMULATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 23051815 ↗MalfunctionMay 9, 2025Ambient Noise Problem; Ambient Noise Problem
LEAD WAS EXPLANTED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997779 ↗InjuryJul 2, 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 19654828 ↗MalfunctionFeb 28, 2024Pacing Problem; High Capture Threshold; Pacing Problem; High Capture Threshold
THIS LEAD SHOWS HIGH PACING THRESHOLDS AND REMAINS IMPLANTED. DEVICE WAS CHANGED OUT DUE TO BATTERY DEPLETION FROM THE HIGH OUTPUTS. 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 18800700 ↗InjurySep 15, 2023Adverse 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 17755480 ↗MalfunctionJun 29, 2023Failure to Capture; Failure to Capture
THIS LV LEAD WAS EXPLANTED DUE TO FAILURE TO CAPTURE. 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 17229801 ↗InjuryJul 29, 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 15130503 ↗InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS LEAD WAS CAPPED DUE TO PHRENIC STIMULATION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 14492904 ↗MalfunctionJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PHRENIC STIMULATION WAS REPORTED. THIS LV LEAD WAS EXPLANTED AND REPLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 13314273 ↗MalfunctionNov 17, 2021Extracardiac stimulation; Extracardiac stimulation
THIS LEAD WAS CAPPED DUE TO DIAPHRAGMATIC STIM. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 12828576 ↗MalfunctionNov 3, 2021High Capture Threshold; High Capture Threshold
LEAD CAPPED DUE TO HIGH THRESHOLD. 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 12745659 ↗MalfunctionSep 27, 2021High impedance; High Capture Threshold; High impedance; High Capture Threshold
HIGH PACING THRESHOLDS AND HIGH PACING IMPEDANCE WERE REPORTED ON THIS LEAD ON (B)(6) 2021, MEASUREMENTS WERE TRENDING UP SINCE (B)(6) 2021. LEAD WAS EXPLANTED ON (B)(6) 2021. 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 12533875 ↗InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD EXPLANTED DUE TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THESE FILES.
Patient problems: Endocarditis
MAUDE report 12436366 ↗InjuryMay 27, 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 11898884 ↗InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD CAPPED DUE TO INFECTION WITH EROSION. DEVICE AND RA LEAD EXTRACTED. LV AND RV CAPPED. PATIENT EXPIRED ON THE SAME DAY AS THE PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 11892973 ↗MalfunctionApr 23, 2021High impedance; High impedance
LEAD EXPLANTED DUE TO HIGH IMPEDANCE. 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 11713004 ↗MalfunctionApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS LEAD WAS CAPPED DUE TO PHRENIC NERVE STIMULATION. THE LEAD WAS NOT REPLACED DUE TO THE AGE OF THE PATIENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 11704501 ↗MalfunctionMar 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD WAS CAPPED DUE TO DISLODGEMENT. IT WAS UNABLE TO BE REPOSITIONED DUE TO SCAR TISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11571025 ↗MalfunctionFeb 9, 2021Ambient Noise Problem; Ambient Noise Problem
POSSIBLE NOISE ON LV NEAR FIELD. NO FAR FIELD VISIBLE FOR REVIEW. FULL 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 11302927 ↗InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EARLY BATTERY DEPLETION. GENERATOR CHANGE WAS SCHEDULED, BUT WHEN OPENING THE POCKET, DEBRIS WAS FOUND IN POCKET, THEREFORE A DEVICE AND LEAD EXTRACTION FOLLOWED. THE COMPLAINT CONCERNING THE ICD WAS REVIEWED AND THE ATTENTION WAS FOCUSED ON THE LEADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10864505 ↗MalfunctionOct 19, 2020Extracardiac stimulation; Extracardiac stimulation
PATIENT IN PERMANENT AFIB. LV LEAD WAS CAPPED DUE TO STIMULATION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 10701665 ↗MalfunctionApr 13, 2020Break; Break
DURING GENERATOR CHANGE, OUTER INSULATION OF THIS LEAD PULLED BACK FROM THE PIN WHEN THE PHYSICIAN PULLED THE LEAD OUT OF THE HEADER. LEAD WAS REPAIRED USING A GUIDANT REPAIR KIT. THRESHOLD WAS 1.3VOLTS AT 0.5 MSEC AND IMP WAS STABLE. LEAD REMAINS ACTIVELY 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 9955049 ↗InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEFT-SIDED DIAPHRAGMATIC STIMULATION WAS REPORTED ON (B)(6) 2018. LEAD WAS REPROGRAMMED, BUT NO SURGICAL INTERVENTION WAS PERFORMED AT THE TIME. ON (B)(6) 2020, THE LEAD WAS EXPLANTED DUE TO PATIENT COMPLAINTS OF PHRENIC NERVE STIMULATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Muscle Stimulation; Undesired Nerve Stimulation
MAUDE report 9716564 ↗MalfunctionNov 20, 2019Break; High impedance; Break; High impedance
THIS LV LEAD WAS EXPLANTED DUE TO DAMAGED INSULATION AND HIGH IMPEDANCE. 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 9349487 ↗
Other Drug eluting permanent left ventricular (lv) pacemaker electrode devices
- Attain Stability™ Quad MRI SureScan™ 479888Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode28 deaths2,213 reports
- Attain Performa™ Straight MRI SureScan™ 439888Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode26 deaths1,595 reports
- Sentus ProMRI OTW QP L-85/49 408719BIOTRONIK SE & Co. KG · Drug eluting permanent left ventricular (lv) pacemaker electrode7 deaths1,385 reports
- Quartet™ 1457Q-86St. Jude Medical, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode21 deaths1,061 reports
- Quickflex™ 1258TSt. Jude Medical, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode26 deaths996 reports
- ATTAIN® BIPOLAR OTW 419488Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode15 deaths730 reports
- Attain Ability® Plus 429688Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode11 deaths529 reports
- Sentus ProMRI OTW QP S-85/49 406082BIOTRONIK SE & Co. KG · Drug eluting permanent left ventricular (lv) pacemaker electrode1 death511 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page