FINELINE II SteroxRecalls & reported problems across all models
Boston Scientific Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,918
- Deaths reported
- 12
- Injuries reported
- 1,553
- Recalls
- 0
We found 6 models of FINELINE II Sterox by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,918 adverse event reports in the FDA's MAUDE database, received between Jul 8, 2013 and Sep 30, 2026 — classified as 12 deaths, 1,553 injuries, 353 malfunctions.
The most frequently reported specific device problem is “High impedance” (437 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 FINELINE II Sterox problems
Device problems
- Adverse Event Without Identified Device or Use Problem616
- High impedance437
- Failure to Capture305
- High Capture Threshold268
- Over-Sensing221
- Fracture199
- Signal Artifact/Noise166
- Pacing Problem154
Patient problems
- Unspecified Infection581
- No Clinical Signs, Symptoms or Conditions523
- No Known Impact Or Consequence To Patient325
- No Consequences Or Impact To Patient217
- No Code Available175
- Sepsis139
- Pocket Erosion73
- Bradycardia27
FINELINE II Sterox models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FINELINE® II Sterox 4457permanent pacemaker Electrode5 deaths726 reports
- FINELINE® II Sterox 4456permanent pacemaker Electrode5 deaths539 reports
- FINELINE® II Sterox 4480permanent pacemaker Electrode1 death324 reports
- FINELINE® II Sterox 4479permanent pacemaker Electrode1 death252 reports
- FINELINE® II Sterox 4459permanent pacemaker Electrode57 reports
- FINELINE® II Sterox 4458permanent pacemaker Electrode20 reports
Recent FINELINE II Sterox adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026High impedance; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955154 ↗MalfunctionSep 30, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954575 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this right atrial (RA) lead was part of a system revision due to infection. There were no additional adverse patient effects reported. The RA lead was explanted.
Patient problems: Unspecified Infection
MAUDE report 50807703 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this right ventricular (RV) lead was part of a system revision due to infection. There were no additional adverse patient effects reported. The RV lead was explanted.
Patient problems: Unspecified Infection
MAUDE report 50807661 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.
Patient problems: Unspecified Infection
MAUDE report 50685037 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50652582 ↗InjurySep 7, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652223 ↗MalfunctionSep 4, 2026Extracardiac stimulation; Low impedance
It was reported that this right atrial (RA) lead triggered exhibited low out of range pace impedance measurements. Technical Services (TS) was consulted and found several dips on RA pace impedance measurements with multiple out of range measurements. TS recommended troubleshooting in hopes of reproducing the out of range measurements or any noise. No adverse patient effects were reported. This RA lead remains in service.
Patient problems: Device Overstimulation of Tissue
MAUDE report 50602200 ↗MalfunctionAug 24, 2026Failure to Capture; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421693 ↗InjuryAug 20, 2026Device Dislodged or Dislocated
It was reported that the patient experienced a burning sensation with this right ventricular (RV) lead which was out of place. The Boston Scientific Technical Services consultant referred the patient to the clinic. As of this time, this RV lead remains in service. No adverse patient effects were reported.
Patient problems: Burning Sensation
MAUDE report 50335464 ↗MalfunctionAug 18, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291910 ↗InjuryAug 14, 2026Pacing Problem; Use of Device Problem
It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced system shortness of breath (SOB) and fatigue. It was noted there was suspicious pacing behavior observed on the electrograms (EGMs). It was hypothesized that at the time of the device upgrade in 2023, the old right ventricular (RV) lead was placed incorrectly in the right atrial (RA) port of this CRT-D, and the old RA lead was mistakenly surgically abandoned. The physician performed a pocket exploration and confirmed the old RV lead was attached to the atrial port, and the RA lead was abandoned. The RV lead was removed from the atrial port and replaced with the RA lead. It was also noted the patient would continue to be monitored and that the patient had an increase in ejection fraction since the CRT-D was implanted. This RV lead was surgically abandoned. No additional adverse patient effects were reported.
Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure
MAUDE report 50260520 ↗MalfunctionAug 14, 2026Device Dislodged or Dislocated
Patient problems: Burning Sensation
MAUDE report 50254238 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this right ventricular (RV) lead was part of a system revision due to infection. There was no additional adverse patient effects reported. The RV lead was explanted.
Patient problems: Unspecified Infection
MAUDE report 50209684 ↗InjuryJul 29, 2026Fracture; Material Integrity Problem
It was reported that this right atrial (RA) lead had fractured and insulation was compromised after physician was making the pocket and accessing the old device with electrical cautery. This lead was surgically abandoned, and a new lead was implanted. No additional adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065983 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
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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