Linox Smart SD 60/16 359065Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 04035479100384), received between Mar 28, 2019 and Mar 24, 2026 — classified as 31 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Ambient Noise Problem” (50 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 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 24680326 ↗
• InjuryJan 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 24087241 ↗
• MalfunctionJul 30, 2025Ambient Noise Problem; Ambient Noise Problem

  THIS LEAD WAS CAPPED DUE TO NOISE. 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 22666398 ↗
• MalfunctionAug 26, 2024High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  LEAD WAS CAPPED DUE TO NOISE ON PACE/SENSE PORTION AND HIGH IMPEDANCE ON SHOCK PORTION. 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 20064890 ↗
• InjuryApr 25, 2024Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  PT PRESENTED TO ED FOR SHOCK. INTERROGATION REVEALS INAPPROPRIATE SHOCK DUE TO LEAD NOISE. LOOKS LIKE IT HAS BEEN HAPPENING SINCE BEGINNING OF APRIL WITH MANY ABORTED SHOCKS AS WELL AS ONE OTHER INAPPROPRIATE SHOCK. DEVICE DEACTIVATED AWAITING TRANSFER TO A HOSPITAL THAT CAN HANDLE. LEAD AND DEVICE REMAIN IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19180458 ↗
• MalfunctionSep 22, 2022Ambient Noise Problem; Ambient Noise Problem

  LEAD WAS CAPPED DUE TO 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 15466799 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 15341700 ↗
• MalfunctionAug 29, 2022Ambient Noise Problem; Ambient Noise Problem

  THIS RV LEAD WAS CAPPED DUE TO 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 15310782 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 15190384 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 15130549 ↗
• MalfunctionJul 12, 2022High impedance; High impedance

  OUT OF RANGE SHOCK IMPEDANCE (GREATER THAN 150 OHMS) BEGINNING ON (B)(6) 2022 ON HOME MONITORING. LEAD TO BE EVALUATED FURTHER AND 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 14986767 ↗
• MalfunctionJun 21, 2022High impedance; High impedance

  HMSC REPORTED SHOCK IMPEDANCE OUT OF RANGE, GREATER THAN 125 OHM. LEAD CURRENTLY 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 14755447 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 14719256 ↗
• MalfunctionJun 14, 2022Ambient Noise Problem; Ambient Noise Problem

  HM REVEALS NOISE ON LEAD. 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 14684662 ↗
• MalfunctionApr 18, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

  THIS LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE AND THRESHOLD. 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 14136570 ↗
• MalfunctionApr 15, 2022Ambient Noise Problem; Ambient Noise Problem

  THIS LEAD WAS PARTIALLY CAPPED DUE TO NOISE. IS-1 PORTION CAPPED AND NEW PACE/SENSE LEAD 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 14117853 ↗
• MalfunctionApr 7, 2022Ambient Noise Problem; Impedance Problem; Ambient Noise Problem; Impedance Problem

  RV LEAD NOISE PRESENT ON IEGMS CONCURRING WITH SUDDEN IMPEDANCE CHANGE BEGINNING (B)(6) 2022. 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 14047557 ↗
• MalfunctionMar 23, 2022High impedance; High impedance

  IT WAS REPORTED THAT THERE WERE MULTIPLE DAYS OF HIGH SHOCK IMPEDANCE OUT OF RANGE. OTHER VALUES WITHIN NORMAL LIMITS. FULL LEAD EVALUATION RECOMMENDED. DEVICE 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 13871175 ↗
• MalfunctionMar 23, 2022Fracture; Fracture

  THIS LEAD WAS CAPPED DUE TO LEAD 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 13870884 ↗
• MalfunctionFeb 7, 2022Ambient Noise Problem; Ambient Noise Problem

  LEAD CAPPED DUE TO NOISE. 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 13472113 ↗
• MalfunctionFeb 7, 2022High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  LEAD CAPPED DUE TO FF NOISE AND SHOCK IMPEDANCE GREATER THAN 150 OHMS INTERMITTENTLY FOLLOWING AN ICD UPGRADE PERFORMED ON (B)(6) 2021. 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 13471749 ↗
• MalfunctionDec 9, 2021Break; Break

  LEAD PARTIALLY CAPPED. RV P/S PIN CAPPED DURING CHANGEOUT PROCEDURE. WHILE CONNECTING THE RV P/S PIN INTO THE NEW DEVICE, THE PHYSICIAN ENGAGED THE SET SCREW FOR THE PIN ELECTRODE AND DID A TUG TEST TO ENSURE THE LEAD WAS PROPERLY SECURED. THE INSULATION BETWEEN THE RING AND THE TIP BROKE LOOSE AND THE CONDUCTOR FOR THE TIP UNRAVELED. THE LEAD WAS CLIPPED DISTAL TO THE RING ELECTRODE AND THE REMAINING LEAD BODY WAS CAPPED PENDING EXTRACTION AT A LATER DATE. 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 12972004 ↗
• MalfunctionDec 7, 2021High impedance; High impedance

  INTERMITTENT GREATER THAN 150 OHMS SHOCK IMPEDANCE SINCE AT LEAST (B)(6) 2019. MOST RECENT HIGH SHOCK IMPEDANCE WAS (B)(6) 2021. RECOMMENDED EVALUATING LEAD IN PERSON WITH ISOMETRIC TESTING. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12951191 ↗
• MalfunctionDec 1, 2021Ambient Noise Problem; Ambient Noise Problem

  RV LEAD CAPPED DUE TO NOISE. 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 12913756 ↗
• MalfunctionNov 24, 2021Ambient Noise Problem; Ambient Noise Problem

  LEAD REMAINS IMPLANTED. POTENTIAL NOISE ON RV LEAD IN FAR FIELD AND RV CHANNELS. PATIENT WILL BE BROUGHT IN FOR HISTORY AND FULL LEAD EVALUATION TO RULE OUT LEAD INTEGRITY VS EXTERNAL EMI INDUCED NOISE. DOCTOR MAY HAVE NICKED THE LEAD UPON IMPLANT. 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 12871809 ↗