ATTAIN STARFIXRecalls & reported problems across all models
Medtronic, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 356
- Deaths reported
- 5
- Injuries reported
- 253
- Recalls
- 0
We found 4 models of ATTAIN STARFIX by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 356 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2014 and Sep 28, 2026 — classified as 5 deaths, 253 injuries, 98 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (105 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 ATTAIN STARFIX problems
Device problems
- High Capture Threshold105
- Adverse Event Without Identified Device or Use Problem103
- High impedance49
- Failure to Capture45
- Low impedance39
- Capturing Problem30
- Fracture29
- Impedance Problem24
Patient problems
- No Clinical Signs, Symptoms or Conditions115
- No Known Impact Or Consequence To Patient96
- Unspecified Infection76
- Undesired Nerve Stimulation20
- Muscle Stimulation17
- Erosion13
- Device Overstimulation of Tissue12
- Erythema10
ATTAIN STARFIX models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ATTAIN STARFIX® 419588Drug eluting permanent left ventricular (lv) pacemaker electrode5 deaths316 reports
- ATTAIN STARFIX® 419578permanent pacemaker Electrode32 reports
- ATTAIN STARFIX™ 419588Drug eluting permanent left ventricular (lv) pacemaker electrode7 reports
- ATTAIN STARFIX™ 419578Drug eluting permanent left ventricular (lv) pacemaker electrode1 report
Recent ATTAIN STARFIX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Capturing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926271 ↗MalfunctionSep 16, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793664 ↗MalfunctionSep 1, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem
It was reported that the Right Atrial (RA) lead exhibited Out of Range (OOR) high pacing impedance , oversensing resulting in inhibition of pacing and misclassification of episode type. The lead also exhibited noise. The patient experienced palpitations and shortness of breath. The lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: Dyspnea; Palpitations
MAUDE report 50550578 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection with sepsis. No further patient complications have been reported as a result of this event.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 50357830 ↗InjuryJun 25, 2026Failure to Capture; Fracture; High impedance
IT WAS REPORTED THAT DURING A GENERATOR CHANGE-OUT, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, OUT-OF-RANGE, UNDEFINED PACING IMPEDANCE, A LOSS OF CAPTURE, AND HAD A FRACTURE. THE LEAD WAS LEFT IMPLANTED, BUT IS NOW OUT-OF-SERVICE AND A NEW LV LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621667 ↗MalfunctionJun 12, 2026Low impedance
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES. THE LEFT VENTRICULAR (LV) LEAD TRIGGERED ALERTS FOR LOW PACING IMPEDANCE, THE MEASUREMENTS WERE CONSISTENT WITH HISTORICAL VALUES. THE RA AND LV LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488929 ↗InjuryMay 27, 2026Failure to Capture
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NON-CAPTURE. THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICAT IONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301296 ↗MalfunctionMay 14, 2026Low impedance
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW OUT OF RANGE (OOR) PACING IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172945 ↗InjuryMay 13, 2026Failure to Capture
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD CHRONICALLY EXHIBITED NO CAPTURE. THE LV LEAD WAS CAPPED, REMAINS IN THE PATIENT OUT OF SERVICE AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164604 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEVER, INFECTION, AND SEPSIS POSSIBLY DUE TO A URINARY TRACT INFECTION APPROXIMATELY FOUR MONTHS PRIOR TO THE EVENT. THE PATIENT EXPERIENCED AN ADDITIONAL URINARY TRACT INFECTION APPROXIMATELY THREE MONTHS PRIOR TO THE EVENT. ADDITIONALLY, VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. DURING THE EXPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE PATIENT SUSTAINED AN INJURY TO THE RIGHT VENTRICLE REQUIRING A STERNOTOMY AND REPAIR. DURING THE EXPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE PATIENT SUSTAINED AN INJURY TO THE CORONARY SINUS THAT WAS REPAIRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Fever; Perforation of Vessels; Sepsis; Unspecified Infection
MAUDE report 24974740 ↗InjuryMar 24, 2026Fracture; High impedance; Impedance Problem; High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOW VOLTAGE FRACTURE WITH A LEFT VENTRICULAR (LV) TIP TO RIGHT VENTRICULAR (RV) COIL LEAD PACING IMPEDANCE WARNING AND UNDEFINED HIGH PACING IMPEDANCE. THE LEAD ALSO EXHIBITED PRIOR SPIKE IN PACING IMPEDANCE AND HIGH THRESHOLD. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24677058 ↗MalfunctionMar 20, 2026High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24653912 ↗MalfunctionMar 20, 2026Low impedance
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR LOW PACING IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24652258 ↗MalfunctionFeb 19, 2026Failure to Capture
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS SUSPECTED OF LOSS OF CAPTURE AND THAT THE PATIENT'S EJECTION FRACTION WAS BEING REDUCED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24394902 ↗InjuryFeb 12, 2026High impedance; Extracardiac stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED HIGH UNDEFINED PACING IMPEDANCE. REPROGRAMMING WAS PERFORMED AND THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Overstimulation of Tissue
MAUDE report 24319987 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
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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