Tendril™ ST (REF 1888TC-52)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,093 adverse event reports that list this exact device (DI 05414734501750), received between Jun 10, 2018 and Sep 30, 2026 — classified as 74 deaths, 1,459 injuries, 1,560 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (1,281 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 3,093 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break; Low impedance; Device Sensing Problem

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed that the right ventricular (RV) lead exhibited low pacing impedance in bipolar configurations, which had been observed for at least the previous year. The patient subsequently presented for a generator change procedure, during which pre-procedure interrogation confirmed low pacing impedance and decreased R-wave amplitudes on the RV lead. During the procedure, it was revealed that the outer insulation of the RV lead was missing from the end of the yoke to approximately 7 mm distal. The insulation damage was visually confirmed. The RV lead was repaired and remained implanted, electrical testing remained unchanged. The patient remained in a stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942668 ↗
• MalfunctionSep 29, 2026Insufficient Device Problem Information

  It was reported that the patient presented for a lead extraction procedure due to right atrial (RA) lead noise. During the RA lead extraction procedure, the physician decided to explant the right ventricular (RV) lead due to the interaction with the laser extraction catheter. The RA lead and the RV lead were successfully explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927275 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  It was reported that the patient¿s right atrial (RA) lead and right ventricular (RV) lead were capped due to unspecified issue. The patient's condition was unknown.

  Patient problems: Insufficient Information

  MAUDE report 50863425 ↗
• MalfunctionSep 17, 2026Signal Artifact/Noise; Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50807952 ↗
• InjurySep 15, 2026Over-Sensing; Low impedance; Capturing Problem

  It was reported that the patient presented to the hospital for a scheduled generator replacement. Prior to the procedure, the patient's right atrial (RA) lead was found to exhibit noise oversensing, a high capture threshold, and low pacing impedance. The physician elected to cap and replaced the RA lead on (b)(6) 2026. The patient remained in stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767551 ↗
• InjurySep 14, 2026Over-Sensing; Pacing Problem; Low impedance

  It was reported that the patient presented to hospital for generator changes. During analysis, it was noted that the right atrial (RA) lead exhibited low pacing impedance and oversensing noise resulting in inappropriate mode switch. The RA 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 50752932 ↗
• 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 50721852 ↗
• MalfunctionSep 9, 2026Break; Failure to Disconnect

  It was reported that the patient presented for a generator change procedure. During the procedure, it was noted that the right ventricular (RV) lead and right atrial (RA) lead could not be removed from the pacemaker header. The physician injected saline into the pacemaker header in an attempt to remove the leads. The RA lead was eventually removed; however, the insulation of the RV lead was damaged, and the RV lead could not be removed from the pacemaker header. The physician subsequently capped the RV lead. The existing RA lead and a new RV lead were connected to the new pacemaker, and the old pacemaker was explanted. The patient remained in stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50685316 ↗
• 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 50682084 ↗
• MalfunctionSep 4, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50623182 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented in clinic due to an unknown adverse event. The patient's Implantable Cardioverter Defibrillator (ICD), Right Ventricular (RV), Right Atrial (RA), and Left Ventricular (LV) leads were all explanted. There were no allegations of malfunction on the ICD system. The patient had no consequences due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479506 ↗
• MalfunctionAug 26, 2026Low impedance

  It was reported that the atrial lead exhibited low pacing impedance intermittently. No intervention or procedure was reported. The patient had no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50446199 ↗
• InjuryAug 21, 2026Break; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  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 50364377 ↗
• MalfunctionAug 20, 2026Over-Sensing; Pacing Problem

  It was reported through a remote transmission that the patient's right atrial (RA) lead was over-sensing noise resulted in inappropriate mode switch episodes. The patient's status was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50335979 ↗
• MalfunctionAug 19, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50333626 ↗
• MalfunctionAug 9, 2026Over-Sensing

  It was reported that the patient presented remotely via Merlin.net. Upon review, the ventricle lead exhibited noise that was over sensed by the device. No intervention was performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50188907 ↗
• InjuryAug 5, 2026Failure to Capture

  It was reported that the patient presented remotely via Merlin.net. Upon review of the transmission, far-field R-wave (Far-R) oversensing and atrial undersensing were identified. The patient subsequently presented to the emergency department for further evaluation. Upon device interrogation, ventricular non-capture was observed at maximum output in both unipolar and bipolar configurations. In addition, the atrial lead exhibited failure to sense. As a result, the pacemaker was explanted and replaced, and the atrial and right ventricular (RV) leads were capped and replaced on (b)(6) 2026. The patient was reported to be stable throughout the event and subsequent procedures.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137910 ↗
• InjuryAug 5, 2026Device Sensing Problem

  It was reported that the patient¿s right atrial (RA) lead exhibited sensing issue. The RA lead was capped and replaced on (b)(6) 2026. Patient status was not reported.

  Patient problems: Insufficient Information

  MAUDE report 50137562 ↗
• InjuryJul 31, 2026Break

  It was reported that the patient presented in clinic for generator upgrade procedure. During procedure, it was noted that the Right Ventricular (RV) lead had been repaired previously due an insulation breach. Capture thresholds, impedance and sensing were normal. The RV lead was explanted and the physician elected to implant a new lead. The patient condition remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100671 ↗
• InjuryJul 27, 2026Over-Sensing

  It was reported that the patient presented in the clinic for a follow-up. Upon interrogation, atrial lead exhibited noise that was oversensed by the device and led to pacing inhibition. The lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50031705 ↗
• InjuryJul 6, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. INTERROGATION REVEALED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION AND INAPPROPRIATE MODE SWITCH. THE RA 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 25727821 ↗
• InjuryJul 6, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) EXHIBITED EPISODES OF NOISE. THE RV LEAD AND RA WERE CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713687 ↗
• InjuryJul 3, 2026Fracture; Over-Sensing

  IT WAS REPORTED THAT REPRODUCIBLE NOISE LEADING TO PACING INHIBITION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. A LEAD FRACTURE WAS SUSPECTED. THE PATIENT IS COMPLETELY PACER DEPENDENT. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THERE WERE NO ADVERSE EVENTS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700724 ↗
• InjuryJul 1, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686421 ↗
• MalfunctionJun 28, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE ATRIAL LEAD EXHIBITED NOISE THAT WAS OVERSENSED BY THE DEVICE WHICH RESULT IN AN INAPPROPRIATE MODE SWITCH. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647992 ↗