DEXTRUSRecalls & reported problems across all models
BIOTRONIK SE & Co. KG · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,134
- Deaths reported
- 10
- Injuries reported
- 702
- Recalls
- 0
We found 3 models of DEXTRUS by BIOTRONIK SE & Co. KG in the FDA's device registry (GUDID). Together they are named in 2,134 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2016 and Nov 25, 2025 — classified as 10 deaths, 702 injuries, 1,422 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (479 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 DEXTRUS problems
Device problems
- Adverse Event Without Identified Device or Use Problem639
- Ambient Noise Problem479
- Over-Sensing376
- Insufficient Device Problem Information335
- High Capture Threshold218
- High impedance204
- Pacing Intermittently151
- Failure to Capture144
Patient problems
- No Clinical Signs, Symptoms or Conditions754
- Unspecified Infection613
- No Known Impact Or Consequence To Patient590
- Sepsis182
- Pocket Erosion51
- Syncope/Fainting25
- Dizziness24
- Syncope23
DEXTRUS models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DEXTRUS 4136Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes5 deaths1,084 reports
- DEXTRUS 4137Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes3 deaths560 reports
- DEXTRUS 4135Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes2 deaths490 reports
Recent DEXTRUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 25, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO POOR SENSING. ANOTHER RA LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645760 ↗InjuryMay 10, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO IT PRESENTING UNDERSENSING ISSUES, WITH THE ISSUE TRACED BACK TO THE LEAD BY EXAMINING THE LEAD BY PACING SYSTEM ANALYZER (PSA). A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16904098 ↗MalfunctionAug 8, 2022Ambient Noise Problem; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: NON-PHYSIOLOGIC TACHYCARDIA EVENTS WITH NOISE (NO SYNCOPE) WERE OBSERVED ON BOTH CHANNELS. PATIENT IS DEVICE DEPENDENT. MAXIMUM LENGTH OF EVENT WAS 4 SECONDS. LEAD REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15188156 ↗MalfunctionAug 8, 2022Ambient Noise Problem; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: NON-PHYSIOLOGIC TACHYCARDIA EVENTS WITH NOISE (NO SYNCOPE) WERE OBSERVED ON BOTH CHANNELS. PATIENT IS DEVICE DEPENDENT. MAXIMUM LENGTH OF EVENT WAS 4 SECONDS. LEAD REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15188114 ↗MalfunctionAug 8, 2022High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RA LEAD WAS EXPLANTED DUE TO HIGH SHOCK IMPEDANCE AND NOISE. 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 15184716 ↗MalfunctionAug 8, 2022High Capture Threshold; High Capture Threshold
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO HIGH PACING THRESHOLD. 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 15184715 ↗InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 15183304 ↗MalfunctionAug 8, 2022Ambient Noise Problem; Impedance Problem; High Capture Threshold; Ambient Noise Problem; Impedance Problem; High Capture Threshold
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS DISPLAYING NOISE WITH DECREASING IMPEDANCES AND INCREASING THRESHOLDS. LEAD WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15183298 ↗InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 15183275 ↗MalfunctionAug 3, 2022Fracture; Fracture
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO A SUSPECTED 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 15158137 ↗MalfunctionAug 3, 2022Fracture; High impedance; Fracture; High impedance
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS CAPPED DUE TO A FRACTURE AND HIGH IMPEDANCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158135 ↗MalfunctionAug 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: AN UNSPECIFIED ISSUE WITH THE RV LEAD WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158129 ↗MalfunctionAug 3, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RA LEAD WAS DISLODGED WITH LOSS OF CAPTURE. THE DEVICE WAS REPROGRAMMED. THE LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158123 ↗MalfunctionAug 3, 2022Fracture; Fracture
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS EXPLANTED DUE TO A 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 15158120 ↗MalfunctionAug 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS EXPLANTED AND REPLACED DUE TO A PRODUCT PERFORMANCE ISSUE. NO OTHER INFORMATION WAS PROVIDED. 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 15158117 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page