Linox Smart T 65 369820Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04035479112998), received between May 22, 2019 and Jun 11, 2025 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “High impedance” (7 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO HIGH RV THRESHOLD AND INCREASING IMPEDANCE MEASUREMENTS. 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 22184775 ↗
• MalfunctionJun 2, 2025Fracture; Fracture

  THIS LEAD WAS CAPPED DUE TO DAMAGE BETWEEN THE YOLK AND CONNECTOR PIN DISCOVERED DURING DEVICE CHANGE. 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 22126257 ↗
• MalfunctionJul 14, 2022Over-Sensing; Low impedance; Over-Sensing; Low impedance

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 134 MONTHS IT WAS REPORTED THAT OVERSENSING IN THE VENTRICULAR CHANNEL AND LOW IMPEDANCE WERE OBSERVED. THE LEAD REVISION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019948 ↗
• InjuryJul 8, 2022Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Impedance Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Impedance Problem

  PATIENT HAS BEEN INAPPROPRIATELY SHOCKED SEVERAL TIMES SINCE (B)(6) 2022 DUE TO LEAD NOISE WITH SUDDEN IMPEDANCE CHANGE. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 14955952 ↗
• MalfunctionJan 26, 2022Impedance Problem; Impedance Problem

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 75 MONTHS IT WAS REPORTED THAT OUT OF RANGE IMPEDANCES WERE DETECTED. A NEW LEAD WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359902 ↗
• MalfunctionDec 6, 2021Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 112 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. THE LEAD WAS CAPPED AND A NEW ICD-SYSTEM WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935164 ↗
• InjuryNov 24, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  AFTER AN IMPLANTATION PERIOD OF APPROX. 85 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED. THE LEAD WAS CAPPED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12869738 ↗
• MalfunctionMar 30, 2021Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 114 MONTHS, OVERSENSING IN THE VENTRICULAR CHANNEL WAS REPORTED DURING A FOLLOW-UP. IT WAS OBSERVED THAT THE ALERTS WERE DUE TO LOSS OF CAPTURE. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593302 ↗
• MalfunctionFeb 11, 2021High impedance; High impedance

  SHOCK IMPEDANCE ABOVE 150 OHMS ON MULTIPLE OCCASIONS. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11319134 ↗
• MalfunctionFeb 10, 2021Ambient Noise Problem; Ambient Noise Problem

  IT WAS REPORTED THAT THERE WAS NOISE DURING TELEMETRY DURING A HOSPITAL DEVICE CHECK. THERAPY WAS CHANGED TO OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310171 ↗
• InjuryJan 4, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED AFTER APPROX. 86 MONTHS IMPLANTATION TIME, THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO OVERSENSING. THE LEAD IS IN THE PATIENT AND IF EXPLANTED, IT WILL BE RETURNED FOR ANALYSIS. THE PATIENT WAS HOSPITALIZED AND THERAPY WAS SET TO OFF.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11113483 ↗
• MalfunctionDec 17, 2020High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  IT WAS REPORTED THAT THERE HAS BEEN A STEADY RISE IN IMPEDANCE ON THIS LEAD, BEGINNING IN LATE (B)(6) 2019. NOISE CAN BE SEEN ON THE FAR FIELD IEGM. FULL FOLLOW UP WAS REQUESTED, 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 11029154 ↗
• MalfunctionOct 27, 2020Failure to Capture; High impedance; Failure to Capture; High impedance

  LEAD WAS CAPPED AND REPLACED DUE TO HIGH IMPEDANCE AND NON CAPTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10744122 ↗
• MalfunctionOct 19, 2020Fracture; Fracture

  THIS LEAD WAS EXPLANTED AND REPLACED DUE TO FRACTURE. 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 10701627 ↗
• InjuryOct 2, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT APPROX. 85 MONTHS AFTER THE IMPLANTATION THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO OVERSENSING. THE PATIENT WAS HOSPITALIZED. THIS RV LEAD WAS DEACTIVATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10623651 ↗
• MalfunctionJul 16, 2020High impedance; High impedance

  IT WAS REPORTED THAT APPROX. 83 MONTHS AFTER THE IMPLANTATION THE SHOCK IMPEDANCE WAS OUT OF RANGE (GREATER THAN 150 OHMS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10287090 ↗
• MalfunctionJun 8, 2020Failure to Capture; High impedance; Failure to Capture; High impedance

  THIS LEAD WAS CAPPED DUE TO LOSS OF CAPTURE AND IMPEDANCES OVER 3000 OHMS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10128858 ↗
• MalfunctionFeb 27, 2020High impedance; High impedance

  SHOCK IMPEDANCE MEASUREMENT WAS MEASURED AT GREATER THAN 150 OHMS, BEGINNING ON (B)(6)2019. PATIENT WAS RECOMMENDED FOR A LEAD EXTRACTION/REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764471 ↗
• InjuryNov 26, 2019Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  PATIENT RECEIVED 3 INAPPROPRIATE SHOCKS DUE TO NOISE ON THE RV LEAD. IMPEDANCE CHANGES OBSERVED CORRESPONDING TO FIRST NOISE EVENTS ON (B)(6) 2019. LEAD REPLACED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 9379594 ↗
• MalfunctionNov 13, 2019High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT APPROX. 61 MONTHS AFTER THE IMPLANTATION, THIS LEAD WAS EXPLANTED DUE TO INCREASED PACING THRESHOLDS AND OUT OF RANGE IMPEDANCE VALUES (GREATER THAN 3000 OHMS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9318338 ↗
• MalfunctionOct 14, 2019Low impedance; Low impedance

  AFTER AN IMPLANTATION PERIOD OF APPROX. 84 MONTHS, IT WAS REPORTED THAT THERE WAS A LOW IMPEDANCE ON THE VENTRICULAR LEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9188734 ↗
• MalfunctionMay 22, 2019Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 73 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633759 ↗