Tendril™ SDX (REF 1688TC-58)Recalls & reported problems

Summary

The FDA's MAUDE database contains 766 adverse event reports that list this exact device (DI 05414734501996), received between Jun 12, 2018 and Sep 17, 2026 — classified as 12 deaths, 536 injuries, 217 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (206 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 766 reports, in the reporter's own words as published by the FDA.

• OtherSep 17, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809896 ↗
• DeathSep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient deceased. There is no known allegation from a health professional that suggests the death was related to the device. It was reported that the causes of death was congestive heart failure complicated by pneumonia in a person with chronic respiratory and renal failure, diabetes, coronary artery atherosclerosis and cardiomyopathy.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50721546 ↗
• MalfunctionAug 24, 2026Fracture; High impedance

  It was reported that Right Ventricular (RV) lead impedance increases suddenly over the upper limit due to suspected lead fracture. Programming changes were made and the lead will be monitored. Patient is doing fine.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410060 ↗
• InjuryAug 24, 2026Capturing Problem

  It was reported that the patient presented to clinic for follow up, the right ventricle (RV) lead exhibited high thresholds. The RV lead was capped and replaced on (b)(6) 2026. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50401867 ↗
• InjuryAug 21, 2026Break; Failure to Capture; Low impedance

  It was reported that the patient presented for an atrioventricular (AV) node ablation procedure on (b)(6) 2026. Interrogation before the procedure revealed that the right ventricular (RV) lead exhibited a positional complete loss of capture. The RV lead was also noted to have low pacing impedance and a breached insulation. The RV lead was capped and replaced on (b)(6) 2026. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360204 ↗
• InjuryAug 19, 2026Break; Low impedance

  It was reported that the patient presented for a follow-up in clinic. Interrogation revealed that the right ventricular (RV) lead exhibited low pacing impedance. The RV lead was capped and replaced on (b)(6) 2026. The patient remained stable before, during and after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334639 ↗
• MalfunctionAug 19, 2026Under-Sensing

  It was reported that the patient presented for a follow up in clinic. It was noted that the right ventricular lead exhibited under-sensing. No intervention was performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50316069 ↗
• InjuryJul 1, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE EPISODES. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678324 ↗
• InjuryJun 11, 2026Failure to Capture; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO EMERGENCY ROOM EXPERIENCING SYNCOPE. DEVICE INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FAILURE TO CAPTURE AND OVERSENSING NOISE RESULTING LOSS OF CAPTURE. PROGRAMMING CHANGES WAS PERFORMED. THE RV LEAD WAS SUBSEQUENTLY CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Syncope/Fainting

  MAUDE report 25466410 ↗
• InjuryJun 4, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING CAUSING PACING INHIBITION. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25387990 ↗
• InjuryMay 24, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. UPON DEVICE INTERROGATION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING, WHICH RESULTED IN PACING INHIBITION. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267340 ↗
• MalfunctionMay 21, 2026No Apparent Adverse Event

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 25250386 ↗
• MalfunctionMay 6, 2026No Apparent Adverse Event

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 25106520 ↗
• MalfunctionApr 29, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LOW PACING IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024896 ↗
• DeathApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE CAUSE OF DEATH WAS DUE TO MULTI ORGAN FAILURE AND CARDIOGENIC SHOCK. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915457 ↗
• InjuryApr 14, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026 DUE TO UNKNOWN REASONS. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24880113 ↗
• InjuryApr 5, 2026Break; Over-Sensing; Failure to Disconnect; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A LEAD REPLACEMENT PROCEDURE. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND OVERSENSING NOISE. DURING THE PROCEDURE, THE RV LEAD WAS BROKEN AND WAS ABANDONED. DURING EXTRACTION, THE RV LEAD WAS STUCK WITH THE RIGHT ATRIAL (RA) LEAD, RESULTING IN THE RA LEAD BEING REMOVED ALONG WITH THE RV LEAD. BOTH THE RA AND RV LEADS WERE EXPLANTED AND REPLACED. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787128 ↗
• InjuryApr 2, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL FOR LEAD REVISION. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD AN INCREASED CAPTURE THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THERE WERE NO PROCEDURAL COMPLICATIONS, AND NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762012 ↗
• InjuryMar 19, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING AND INTERMITTENTLY AFFECTED PACING FUNCTION. THE RV LEAD WAS CAPPED AND REPLACED (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636176 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC WITH RIGHT VENTRICULAR (RV)-ONLY PACING. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2026 WHILE THE RV LEAD REMAINED IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635950 ↗
• MalfunctionMar 4, 2026Failure to Capture; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED LOW OUT OF RANGE IMPEDANCE AND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. NO PATIENT SYMPTOMS OR INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504177 ↗
• InjuryFeb 19, 2026Failure to Capture; High impedance; Failure to Sense

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, THE RIGHT VENTRICLE EXHIBITED HIGH PACING IMPEDANCE. DURING A FOLLOW-UP IN THE CLINIC, ADDITIONALLY THE LEAD EXHIBITED FAILURE TO CAPTURE AND FAILURE TO SENSE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389496 ↗
• MalfunctionFeb 17, 2026Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT ATRIAL OVERSENSING WAS NOTED ON THE DEVICE. ADDITIONALLY, NOISE AND FAR R OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD AND LOSS OF CAPTURE AND NOISE WERE SEEN ON THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTION WAS MADE AT THIS TIME. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364474 ↗
• InjuryFeb 10, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW UP. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301699 ↗
• InjuryFeb 5, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR DEVICE ANALYSIS. IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE OVER-SENSING; HOWEVER, THE NOISE WAS NOT REPRODUCED DURING INTERROGATION. THE LEAD WAS CAPPED AND REPLACED WITH A LEFT BUNDLE BRANCH AREA PACING (LBBAP) LEAD ON (B)(6) 2026. THE PATIENT WAS DISCHARGED POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265629 ↗