Linox Smart S DX 65/15 365500Recalls & reported problems

Summary

The FDA's MAUDE database contains 632 adverse event reports that list this exact device (DI 04035479110017), received between Jun 14, 2018 and Sep 25, 2026 — classified as 1 death, 185 injuries, 446 malfunctions.

The most frequently reported specific device problem is “Ambient Noise Problem” (306 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 632 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Device Sensing Problem

  The pace/sense portion of this RV lead was capped due to loss of sensing. 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 50899163 ↗
• InjurySep 16, 2026High Capture Threshold

  High RV threshold ([email protected]) at time of Gen change. Capped P/S portion and added new pacing lead. Should additional information be received this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787570 ↗
• InjurySep 14, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  In 2020 this lead was partially capped (pace/sense) due to noise and inappropriate shocks and a new RV pace/sense lead was added. Today, noise was seen on the RA dipoles of this lead. Lead currently remains implanted. Should additional information be received this file will be updated.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50752621 ↗
• InjurySep 11, 2026Device Sensing Problem; High Capture Threshold

  This lead was capped due to High RV threshold, Low DX sensing and Low RV sensing. Should additional information be received this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734314 ↗
• InjurySep 2, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568976 ↗
• InjuryAug 31, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  Patient was taken to ED by EMS (b)(6) 2026 due to four inappropriate shocks received. ED documentation for the (b)(6) 2026 visit provided the following information. Per the included EMS notes, pt told them he experienced a shock Saturday, (b)(6) 2026 and went to the hospital but did not want to be admitted and left; then three more shocks were experienced starting at 5 am, (b)(6) 2026. Per notes, pt reported chest pain and ICD discharge without preceding symptoms; device was interrogated at facility and reported approximately three inappropriate shocks due to oversensing of RV lead. Noise was also noted, with device at ERI when previously noted to have 3-6 months remaining battery life during (b)(6) 2026 interrogation (there was a planned device changeout scheduled for known ERI two weeks prior to (b)(6) 2026 ED visit but pt had elected to delay the procedure). Per history noted, there was only one previously documented shock in (b)(6) 2017. Notes state that during (b)(6) 2026 ED visit, pt was seen by EP Cath Lab Surgery and a left heart catheterization with LAD Fractional Flow Reserve, as well as EKGs/CXR were performed, with no culprit lesion seen. The device was deactivated and

  Patient problems: Chest Pain; Shock from Patient Lead(s)

  MAUDE report 50531396 ↗
• MalfunctionAug 31, 2026Ambient Noise Problem; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50527637 ↗
• InjuryAug 31, 2026Device Sensing Problem

  This lead was capped due to low r wave and p wave amplitudes. (0.2 mV p waves, 2 mV R waves) as a result of slack on the lead pulling back. 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 50526510 ↗
• MalfunctionAug 20, 2026High impedance

  HMSC reported shock impedance >150 Ohm intermittently since at least Apr 2026. All other trends appear unremarkable. Lead currently remains implanted. Should additional information be received this file will be updated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50347664 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  System was explanted due to possible infection from non-healing wound. Should additional information be received, this file will be updated.

  Patient problems: Unspecified Infection

  MAUDE report 50230292 ↗
• InjuryAug 12, 2026Device Sensing Problem

  Lead was capped due to low R wave Sensing <2.0 mV. 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 50230233 ↗
• InjuryAug 4, 2026Inappropriate/Inadequate Shock/Stimulation

  This lead was capped due to inappropriate shocks. Should additional information become available, this file will be updated. This report reflects information received by FDA in the form of a notification per 803.22 (b)(2). Received voluntary anonymous MedWatch report, MW5190114.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50134820 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  SYSTEM AND THIS PREVIOUSLY CAPPED LEAD WERE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 25755848 ↗
• MalfunctionJun 30, 2026Ambient Noise Problem

  LEAD NOISE SEEN ON MULTIPLE HMSC IEGMS. SHORT INTERVAL >0. RECOMMENDED XRAY FOR PIN EVALUATION AND ISOMETRIC TESTING TO EVALUATE LEAD FOR LEAD INTEGRITY CONCERN. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25671807 ↗
• InjuryJun 24, 2026Ambient Noise Problem

  THIS 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 25615871 ↗
• MalfunctionJun 12, 2026Impedance Problem

  HMSC REPORTED SHOCK IMPEDANCE GRADUALLY DECREASING OVER THE PAST YEAR. RECENT SHOCK IMPEDANCE MEASUREMENTS SHOW THAT THE VALUE HAD INCREASED. RA AND RV SENSING AMPLITUDES APPEARS TO GRADUALLY DECREASE AS WELL. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488061 ↗
• MalfunctionJun 10, 2026Ambient Noise Problem

  NOISE TRIGGERED NST EPISODE. NO OTHER VT DETECTION OR THERAPY TRIGGERED DUE TO NOISE. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461955 ↗
• InjuryJun 10, 2026Ambient Noise Problem

  THIS LEAD WAS EXPLANTED 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 25457643 ↗
• MalfunctionJun 3, 2026Ambient Noise Problem

  ATRIAL DIPOLE AND RV LEAD NOISE NOTED ON 13-APR-26 DURING ROUTINE CHECK. NOISE REPRODUCIBLE VIA ISOMETRICS. 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 25375871 ↗
• InjuryMay 29, 2026Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  THIS LEAD WAS CAPPED DUE TO NOISE AND POSSIBLE FRACTURE LEADING TO INAPPROPRIATE SHOCK. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25332722 ↗
• InjuryMay 18, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  THIS RV LEAD WAS CAPPED DUE TO NOISE LEADING TO 49 VF EVENTS AND 39 SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25210867 ↗
• InjuryMay 13, 2026Fracture

  LEAD WAS EXPLANTED DUE TO FRACTURE. 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 25162360 ↗
• InjuryMay 11, 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 25137172 ↗
• MalfunctionMay 8, 2026Ambient Noise Problem; Impedance Problem

  NOISE HAS BEEN DETECTED ON THE RV CHANNEL SINCE (B)(6) 2026, COINCIDING WITH A SHARP RISE IN DAILY SHORT RV INTERVAL COUNTS FROM THAT DATE ONWARD. BEGINNING (B)(6) 2026, INTERMITTENT DAILY SHOCK IMPEDANCE VALUES GREATER THAN 150 OHMS HAVE ALSO BEEN OBSERVED. RV PACING IMPEDANCE, THRESHOLDS, AND SENSING AMPLITUDES REMAIN STABLE AND WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EVENTS WERE REPORTED. THE LEAD REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123212 ↗
• MalfunctionApr 29, 2026Ambient Noise Problem

  NOISE IS SEEN ON ATRIAL CHANNEL ON RECORDINGS, AS WELL AS ON FARFIELD CHANNEL. NO THRESHOLD WAS ABLE TO BE CHECKED IN OFFICE DUE TO PATIENT NOT FEELING WELL AND HIGH HEART RATE. ALSO THEY DID NOT DO POCKET MANIPULATION OR ISOMETRICS DUE TO PATIENT NOT FEELING WELL. PATIENT WILL BE BROUGHT BACK INTO OFFICE FOR FURTHER TESTING. ATRIAL MINIMUM THRESHOLD IS ALREADY PROGRAMMED TO 1.0 MV. LEAD CURRENTLY REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036375 ↗