Tendril™ ST (REF 1888TC-58)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,673 adverse event reports that list this exact device (DI 05414734501705), received between Jun 11, 2018 and Sep 28, 2026 — classified as 21 deaths, 815 injuries, 837 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (553 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 1,673 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Over-Sensing

  It was reported that the patient was scheduled for a generator changeout procedure. The right ventricular (RV) lead exhibited noise, resulting in pacing inhibition. The RV lead was explanted and replaced on (b)(6)2026. The patient was reported to be in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910815 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported via product return that the patient with the pacemaker and Right Ventricular lead implanted passed away due to hypertension, cardiovascular disease, and effusions. Further information was requested but has not yet been received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812180 ↗
• MalfunctionSep 17, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50807939 ↗
• MalfunctionSep 10, 2026Failure to Capture; High impedance; Low impedance

  Patient problems: Dizziness

  MAUDE report 50721367 ↗
• MalfunctionSep 9, 2026Signal Artifact/Noise

  It was reported that the patient presented to the clinic for a follow up. Interrogation of the pulse generator noted that the right ventricular (RV) and the right atrial (RA) leads exhibited noise which was reproducible with arm movements. No intervention was performed, and the clinic will continue to monitor the patient. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50682086 ↗
• MalfunctionAug 21, 2026Break

  It was reported that the patient presented for an explant procedure. Prior to the procedure, it was noted that the right atrial (RA) lead had dislodged and exhibited poor sensing and capture. During the procedure the insulation damage was noted on the right atrial lead and right ventricular (RV) lead. The RA and RV leads was explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50364381 ↗
• InjuryAug 20, 2026Signal Artifact/Noise

  It was reported that the asymptomatic patient presented for a clinical follow-up. During the follow-up, noise was observed on the right ventricular (RV) lead. The RV lead was capped and replaced on (b)(6) 2026. The patient remained stable throughout the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50336300 ↗
• MalfunctionAug 17, 2026Break

  It was reported that the patient presented for a scheduled pacemaker exchange procedure. During the procedure, after opening the pocket, insulation damage was noted the right ventricular (RV) lead. The lead was capped and replaced on (b)(6) 2026. The patient was discharged with no adverse consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268685 ↗
• MalfunctionJun 26, 2026Break; Fracture; Capturing Problem

  IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT, FRACTURE, INSULATION BREACH AND HIGH THRESHOLDS WERE SEEN ON RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635643 ↗
• InjuryJun 22, 2026Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE INSULATION OF THE RIGHT VENTRICULAR (RV) LEAD HAD DAMAGED. THE INSULATION DAMAGE WAS CONFIRMED THROUGH VISUAL INSPECTION. 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 25588891 ↗
• InjuryJun 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE THAT WAS OVERSENSED BY THE DEVICE. 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 25422617 ↗
• MalfunctionJun 4, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION NOTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE. OVERSENSING NOISE OF RV LEAD RESULTING IN PACING INHIBITION. NO CHANGE OR INTERVENTION WAS REPORTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393224 ↗
• MalfunctionMay 28, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE PROBLEM. NO CHANGES OR INTERVENTIONS WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.

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

  MAUDE report 25326079 ↗
• MalfunctionMay 15, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN CLINIC FOLLOW-UP. DEVICE INTERROGATION REVEALED THAT NOISE OVERSENSING RESULTING IN INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS) WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190110 ↗
• InjuryMay 11, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD, AND THE PATIENT¿S RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOISE THAT RESULTED IN INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). THE PHYSICIAN ELECTED TO EXPLANT BOTH LEADS AND IMPLANT AN AVEIR DR SYSTEM. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145283 ↗
• InjuryApr 27, 2026High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. UPON DEVICE INTERROGATION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE. 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 25010655 ↗
• InjuryApr 20, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO THE NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT THE RV LEAD AND REPLACE IT WITH A NEW ONE. THE PATIENT'S CONDITION REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933590 ↗
• MalfunctionMar 30, 2026Break; Over-Sensing; Pacing Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT RIGHT ATRIAL (RA) LEAD DAMAGE WAS ALLEGED BUT NOT CONFIRMED. THE DEVICE WAS REPROGRAMMED TO DEACTIVATE THE RA LEAD TO RESOLVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735444 ↗
• InjuryMar 24, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678226 ↗
• MalfunctionMar 11, 2026Failure to Capture; High impedance

  DURING A REMOTE FOLLOW-UP, INCREASED CAPTURE THRESHOLD WHICH RESULTED IN LOSS OF CAPTURE AND INCREASED PACING IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE ALLEGED CAUSE OF THE EVENT WAS DUE TO CALCIFICATION, ALTHOUGH NOT CONFIRMED. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571422 ↗
• InjuryMar 11, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM. UPON DEVICE INTERROGATION, THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED CAPTURE THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS DISCHARGED WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 24567338 ↗
• InjuryMar 10, 2026Failure to Capture; Low impedance

  IT WAS REPORTED THAT DURING A DEVICE CHECK, BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCES WERE LOW OUT OF RANGE. BOTH OF THE LEAD IMPEDANCES WERE SUDDENLY MEASURED ABNORMALLY AT THE SAME TIME BETWEEN (B)(6) 2025. THE LAST DEVICE CHECK WAS PERFORMED IN (B)(6) 2019. NO CAPTURE WAS ALSO OBSERVED ON THE RV LEAD. THE PATIENT WAS ALSO TESTED POSITIVE FOR BACTEREMIA IN THE BLOODSTREAM UNRELATED TO THE PRODUCTS. THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24558817 ↗
• MalfunctionMar 2, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. NO OTHER INFORMATION WAS AVAILABLE. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24480514 ↗
• MalfunctionFeb 22, 2026Failure to Capture; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. UPON PERFORMING CAPTURE TEST, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD FAILED TO CAPTURE AND ALSO CAUSED POCKET STIMULATION WHICH RESULTED IN DISCOMFORT. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort

  MAUDE report 24410986 ↗
• MalfunctionFeb 4, 2026Break; Over-Sensing

  IT WAS REPORTED THAT NOISE LEADING TO OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. LEAD DAMAGE WAS SUSPECTED BUT WAS NOT CONFIRMED VISUALLY. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262265 ↗