CoroxRecalls & reported problems across all models
BIOTRONIK SE & Co. KG · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 214
- Deaths reported
- 1
- Injuries reported
- 73
- Recalls
- 0
We found 6 models of Corox by BIOTRONIK SE & Co. KG in the FDA's device registry (GUDID). Together they are named in 214 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2016 and May 21, 2026 — classified as 1 death, 73 injuries, 140 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (43 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Corox problems
Device problems
- Adverse Event Without Identified Device or Use Problem69
- High Capture Threshold43
- Failure to Capture31
- Device Dislodged or Dislocated30
- High impedance22
- Ambient Noise Problem16
- Extracardiac stimulation10
- Break6
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Known Impact Or Consequence To Patient65
- Unspecified Infection51
- Undesired Nerve Stimulation17
- Muscle Stimulation7
- Pocket Erosion6
- Device Embedded In Tissue or Plaque2
- Cardiac Perforation1
Corox models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Corox OTW-L 85-BPDrug eluting permanent left ventricular (lv) pacemaker electrode73 reports
- Corox OTW-S 75-BPDrug eluting permanent left ventricular (lv) pacemaker electrode42 reports
- Corox OTW-S 85-BPDrug eluting permanent left ventricular (lv) pacemaker electrode36 reports
- Corox OTW-L 75-BPDrug eluting permanent left ventricular (lv) pacemaker electrode31 reports
- Corox OTW 85-BPDrug eluting permanent left ventricular (lv) pacemaker electrode19 reports
- Corox OTW 75-BPDrug eluting permanent left ventricular (lv) pacemaker electrode1 death13 reports
Recent Corox adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗MalfunctionAug 27, 2025High Capture Threshold; High Capture Threshold
THIS LV LEAD WAS DEACTIVATED DUE TO CHRONICALLY ELEVATED THRESHOLDS CAUSING PREMATURE ICD ERI. 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 22907224 ↗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 ↗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 ↗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 ↗InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD INFECTION. THE DEVICE WAS EXPLANTED AND THE LEADS WERE CAPPED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 20592071 ↗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 ↗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 ↗MalfunctionJun 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LV LEAD WAS CAPPED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19577107 ↗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 ↗
Other BIOTRONIK SE & Co. KG products
All BIOTRONIK SE & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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