Linox Smart SD 65/18 359067Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Linox Smart defibrillator lead has 192 reports, 67 injuries and 1 death. Many reports describe electrical noise on the lead, sometimes leading to inappropriate shocks, and some describe high shock impedance or fractures, with some systems removed because of infection. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 193
- Deaths reported
- 1
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 04035479100407), received between Jul 13, 2016 and Sep 29, 2026 — classified as 1 death, 68 injuries, 124 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (74 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.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem74
- High impedance41
- Inappropriate/Inadequate Shock/Stimulation36
- Adverse Event Without Identified Device or Use Problem31
- Over-Sensing27
- Fracture22
- High Capture Threshold10
- Break9
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Known Impact Or Consequence To Patient57
- Shock from Patient Lead(s)35
- Unspecified Infection27
- Ventricular Fibrillation2
- Cardiomyopathy1
- Hematoma1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 193 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926760 ↗InjurySep 25, 2026Unstable Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905338 ↗InjuryApr 21, 2026High impedance
LEAD WAS EXPLANTED DUE TO SHOCK IMPEDANCE GREATER THAN 150. 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 24947637 ↗MalfunctionDec 30, 2025Ambient Noise Problem; Device Sensing Problem; Ambient Noise Problem; Device Sensing Problem
IN OFFICE FOLLOW-UP SHOWS NOISE ON RV CHANNEL AFTER PACE DURING THRESHOLD TESTING. HMSC DATA SHOWS PRESENCE OF SHORT INTERVAL COUNTS FOR THIS DEVICE. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926347 ↗MalfunctionSep 3, 2025Ambient Noise Problem; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22958563 ↗MalfunctionJul 30, 2025Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
LEAD WAS CAPPED DUE TO FRACTURE WITH 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 22671798 ↗MalfunctionJul 24, 2025High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem
OUT OF RANGE SHOCK IMPEDANCE (GREATER THAN 150 OHMS) AND NOISE ON THE RV CHANNEL WERE SEEN IN RECORDINGS TRANSMITTED TO HOME MONITORING. LEAD TO BE EVALUATED FURTHER AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22593963 ↗MalfunctionMar 11, 2025High impedance; High impedance
HIGH SHOCK IMPEDANCES OF GREATER THAN 150 OHMS WAS REPORTED ON THIS RV LEAD. RECENTLY, SHOCK IMPEDANCE HAS FLUCTUATED INTERMITTENTLY TO IN-RANGE MEASUREMENTS ALSO. LEAD TO BE EVALUATED FURTHER AND REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21574635 ↗InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD INFECTION. THE DEVICE WAS EXPLANTED AND THE LEADS WERE CAPPED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 20592093 ↗MalfunctionJul 15, 2024Ambient Noise Problem; Ambient Noise Problem
THE PACE/SENSE PORTION OF THIS LEAD WAS CAPPED DUE TO NOISE. SHOCK PORTION REMAINS ACTIVE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19747148 ↗MalfunctionJun 5, 2024Fracture; Fracture
LEAD WAS EXPLANTED DUE TO FRACTURE. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19468747 ↗MalfunctionApr 23, 2024Ambient Noise Problem; Ambient Noise Problem
NOISE WAS SEEN ON RECORDINGS FOR THIS LEAD IN THE NEARFIELD AND FARFIELD SIGNALS. NO ADVERSE PATIENT EVENTS WERE REPORTED. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19162731 ↗MalfunctionFeb 26, 2024Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
PACE/SENSE PORTION OF 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 18778812 ↗MalfunctionNov 6, 2023Under-Sensing; Under-Sensing
THIS RV LEAD WAS EXPLANTED DUE TO LOW R WAVE. 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 18073758 ↗MalfunctionAug 11, 2023Ambient Noise Problem; Ambient Noise Problem
REPRODUCIBLE NOISE WAS REPORTED ON THE ATRIAL AND FAR-FIELD CHANNELS DURING TESTING IN OFFICE. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17515331 ↗MalfunctionJun 21, 2023Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE AND POSSIBLE 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 17169852 ↗MalfunctionJun 14, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold
THIS LEAD WAS CAPPED DUE TO INCREASED IMPEDANCE (2134 OHMS) AND THRESHOLD ([email protected]). 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 17131478 ↗MalfunctionApr 3, 2023Ambient Noise Problem; Ambient Noise Problem
NOISE CAN BE SEEN ON HMSC CAUSING INAPPROPRIATE VF DETECTIONS. NO INAPPROPRIATE THERAPY HAS BEEN DELIVERED. LEAD TRENDS ARE STABLE AND WITHIN NORMAL RANGE. THE PATIENT WILL BE BROUGHT IN FOR LEAD EVALUATION. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16665955 ↗InjuryDec 30, 2022Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD SHOWS NOISE AND DELIVERED INAPPROPRIATE SHOCKS. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 16078242 ↗MalfunctionNov 23, 2022Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
LEAD WAS CAPPED DUE TO FRACTURE CAUSING NOISE ON LEAD. 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 15852050 ↗InjuryAug 23, 2022High impedance; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; High impedance; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
LEAD SHOWED IMPEDANCE GREATER THAN 3,000 AND NOISE RESULTING IN INAPPROPRIATE SHOCKS. LEAD WAS EXTRACTED VIA LASER WITH NO COMPLICATIONS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 15279754 ↗InjuryAug 12, 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 15217036 ↗MalfunctionAug 2, 2022Ambient Noise Problem; Ambient Noise Problem
THIS RV LEAD WAS EXPLANTED 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 15147045 ↗InjuryJul 28, 2022Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS EXPLANTED DUE TO NOISE AND INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 15126790 ↗MalfunctionJul 26, 2022High impedance; Loose or Intermittent Connection; High impedance; Loose or Intermittent Connection
ON (B)(6) 2022 THE INFORMATION ABOUT THE LEAD IDENTITY WAS RECEIVED. THIS LEAD WAS CAPPED, LEFT IN THE PATIENT AND REPLACED BY A NEW ONE APPROX. 117 MONTHS AFTER THE IMPLANTATION. AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 20 DAYS IT WAS REPORTED THAT THE ICD WAS EXPLANTED DUE TO HIGH SHOCK IMPEDANCE. A CONNECTION ISSUE WAS OBSERVED BETWEEN LEAD AND ICD DURING THE EXPLANT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103971 ↗
Other Permanent defibrillator electrodes devices
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- Capsurefix® Novus 5076-52Medtronic, Inc. · Permanent defibrillator electrodes111 deaths9,860 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes80 deaths8,280 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Medtronic, Inc. · Permanent defibrillator electrodes116 deaths7,750 reports
- Durata™ 7122Q-58St. Jude Medical, Inc. · Permanent defibrillator electrodes151 deaths6,202 reports
- Durata™ 7122Q-65St. Jude Medical, Inc. · Permanent defibrillator electrodes86 deaths4,773 reports
- Capsurefix® Novus 5076-58Medtronic, Inc. · Permanent defibrillator electrodes47 deaths4,587 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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