SoliaRecalls & reported problems across all models
BIOTRONIK SE & Co. KG · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 282
- Deaths reported
- 2
- Injuries reported
- 101
- Recalls
- 0
We found 4 models of Solia by BIOTRONIK SE & Co. KG in the FDA's device registry (GUDID). Together they are named in 282 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2019 and Sep 29, 2026 — classified as 2 deaths, 101 injuries, 179 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (111 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 Solia problems
Device problems
- Device Dislodged or Dislocated111
- Adverse Event Without Identified Device or Use Problem91
- High Capture Threshold36
- Failure to Capture20
- High impedance16
- Ambient Noise Problem8
- Break5
- Device Sensing Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions137
- Unspecified Infection76
- No Known Impact Or Consequence To Patient47
- Wound Dehiscence6
- Pain4
- Cardiac Perforation3
- Hematoma3
- Perforation3
Solia models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Solia JT 45Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes87 reports
- Solia T 60Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes1 death74 reports
- Solia JT 53Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes1 death67 reports
- Solia T 53Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes54 reports
Recent Solia adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Capture; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926839 ↗InjurySep 16, 2026Device 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 50794175 ↗InjurySep 16, 2026Adverse 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 50789561 ↗InjurySep 16, 2026Adverse 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 50788817 ↗InjurySep 15, 2026Entrapment of Device
Lead was attempted but it was unable to be removed due to possible entanglement on sub valvular structure so it was capped and another lead placed successfully. Lead remains inactive in the body.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778705 ↗InjurySep 8, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671263 ↗InjurySep 3, 2026Adverse 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 50590291 ↗InjuryAug 18, 2026Device Dislodged or Dislocated
This lead was repositioned due to dislodgement. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311145 ↗MalfunctionAug 4, 2026High impedance; Ambient Noise Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136368 ↗InjuryJun 15, 2026Adverse 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 25512525 ↗InjuryMay 13, 2026High Capture Threshold
LEAD WAS CAPPED DUE TO HIGH RV LEAD 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 25162363 ↗InjuryMay 5, 2026Adverse 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 25085677 ↗InjuryMar 23, 2026Adverse 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 24661546 ↗InjuryMar 5, 2026High Capture Threshold
LEAD WAS CAPPED DUE TO ELEVATED THRESHOLDS REQUIRING HIGHER 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 24515870 ↗InjuryFeb 17, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24372667 ↗
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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