Tendril™ STS (REF 2088TC-46)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,776 adverse event reports that list this exact device (DI 05414734502870), received between Jun 11, 2018 and Sep 30, 2026 — classified as 190 deaths, 4,247 injuries, 2,339 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (1,803 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 6,776 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Low impedance; Capturing Problem

  It was reported that, during an in-clinic the patient device's battery was at end of life, and it was noted that the lead's pacing impedance was low with high capture threshold. The physician decided to replace the generator, and both leads with a new system, the leads were capped on (b)(6) 2026. There were no adverse events reported. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952734 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with an infection at the device site. No erosion was observed. The pacemaker, right atrial lead and right ventricular lead were explanted. The patient remained stable throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50910893 ↗
• InjurySep 28, 2026Insufficient Device Problem Information

  It was reported that the patient experienced pocket pain and the right atrial (RA) lead was dysfunction. The pacemaker was repositioned; the RA lead was explanted and replaced. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910856 ↗
• InjurySep 28, 2026Signal Artifact/Noise

  It was reported that the patient experienced pocket discomfort, and the right atrial (RA) lead exhibited noise. The pacemaker and the RA lead were explanted and replaced with a leadless pacemaker. The patient was recovering post-procedure.

  Patient problems: Discomfort

  MAUDE report 50910806 ↗
• MalfunctionSep 25, 2026High impedance; Over-Sensing; Pacing Problem; Therapy Delivered to Incorrect Body Area; Capturing Problem; Device Sensing Problem

  It was reported that a patient presented to clinic for a pacemaker check. Device interrogation revealed oversensing noise resulting in inappropriate mode switch episodes, high pacing impedance, low P-wave amplitudes, and high capture thresholds on the atrial lead. Changing from bipolar to unipolar pacing resulted in extracardiac muscle stimulation. Device was reprogrammed from dual chamber pacing and sensing (DDDR) to ventricular pacing while maintaining dual chamber sensing (VDDR). Patient was stable before, during, and after the check.

  Patient problems: Discomfort

  MAUDE report 50898173 ↗
• InjurySep 24, 2026Capturing Problem; Device Dislodged or Dislocated

  It was reported that the patient presented to the hospital with fatigue, weakness, reduced exercise tolerance, and chest discomfort. X-ray, fluoroscopy, and electrocardiogram (ECG) analysis were performed and revealed that the patient's Right Atrial (RA) lead had dislodged. Programming changes were made, and the physician elected to explant the RA lead and replace it with a new lead. The patient's condition remained stable.

  Patient problems: Discomfort; Fatigue

  MAUDE report 50885315 ↗
• InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50834702 ↗
• InjurySep 20, 2026Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834688 ↗
• InjurySep 18, 2026Therapy Delivered to Incorrect Body Area

  It was reported that the patient presented in clinic for a routine device check a few months ago, experiencing discomfort due to right atrial (RA) lead pocket stimulation. Device reprogramming was performed; however, RA lead pocket stimulation persisted. The RA lead was subsequently capped and replaced on (b)(6)2026. The patient was in stable condition.

  Patient problems: Discomfort

  MAUDE report 50814082 ↗
• MalfunctionSep 18, 2026Capturing Problem

  It was reported that the patient's right atrial (RA) lead exhibited alerts of high capture threshold and the right ventricular (RV) lead exhibited alerts of high capture threshold and failure to capture. The patient's status was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813149 ↗
• InjurySep 17, 2026Over-Sensing; Pacing Problem

  It was reported that the patient's right atrial (RA) lead exhibited noise over-sensing resulting in inappropriate mode switch (AMS). The RA lead was explanted and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809456 ↗
• MalfunctionSep 17, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50808518 ↗
• InjurySep 17, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented to the clinic for a device replacement procedure. During evaluation, noise oversensing was observed on the atrial lead, resulting in multiple Auto Mode Switch (AMS) episodes. The device replacement was completed successfully, and the atrial lead remained in use on (b)(6) 2026. The atrial lead will continue to be monitored. The patient had no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798074 ↗
• InjurySep 16, 2026Difficult to Fold, Unfold or Collapse; Device Dislodged or Dislocated

  It was reported that the patient presented to the clinic. Upon device interrogation, the right atrial (RA) lead was found to be dislodged, which was subsequently confirmed by chest X-ray. The physician elected to reposition the lead. During the repositioning procedure, the helix could not be re-extended. As a result, the RA lead was explanted and replaced. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791442 ↗
• InjurySep 16, 2026Failure to Capture

  It was reported that the patient presented in the clinic for a follow-up. Upon interrogation, the atrial lead exhibited failure to capture. The lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788272 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with bacteremia. The physician explanted the entire system ¿ pacemaker, right ventricular lead and atrial lead due to infection. The patient status was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50767331 ↗
• MalfunctionSep 15, 2026Signal Artifact/Noise

  Patient problems: Insufficient Information

  MAUDE report 50765942 ↗
• InjurySep 14, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that during a follow-up in clinic upon interrogation, Right Atrial (RA) lead exhibited non-capture and sensing. Testing was done at high outputs with no capture. Dislodgment was noted under X-ray. The lead was explanted and replaced with Aveir Leadless Pacemaker successfully. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754469 ↗
• InjurySep 10, 2026Over-Sensing; Pacing Problem; Therapy Delivered to Incorrect Body Area; Naturally Worn

  It was reported that the patient experienced extra cardiac stimulation. It was noted that the right atrial (RA) lead exhibited noise oversensing, resulting in inappropriate automatic mode switching (AMS). During the lead revision procedure, conductor externalization was also noted. The RA lead was capped and replaced on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: Discomfort

  MAUDE report 50715468 ↗
• InjurySep 9, 2026Over-Sensing; Pacing Problem

  It was reported that the patient's right atrial (RA) lead exhibited noise over-sensing resulting in inappropriate mode switch (AMS). Pacing inhibition was also noted. The RA lead was explanted and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692863 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the emergency department and was admitted due to a pocket infection. It was visually observed that there was pocket swelling. The physician believed that the infection was procedure-related and not product-related. The entire system, including the pacemaker, the right ventricular lead, and the right atrial lead was explanted. The patient remained in a stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50659294 ↗
• MalfunctionSep 4, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50617226 ↗
• InjurySep 4, 2026Break; Over-Sensing

  It was reported that Right Atrial (RA) lead exhibited known nose. The noise was over-sensed. Suspected insulation breach causing noise. The lead was explanted and replaced without complications. The patient is discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612863 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise

  It was reported that the patient's right atrial (RA) lead exhibited noise. No changes or intervention were reported. The patient condition was not known.

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

  MAUDE report 50604475 ↗
• MalfunctionSep 2, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576850 ↗