Tendril™ STS (REF 2088TC-52)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19,632 adverse event reports that list this exact device (DI 05414734502887), received between Jun 10, 2018 and Sep 30, 2026 — classified as 438 deaths, 10,965 injuries, 8,229 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (5,334 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 19,632 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955153 ↗
• 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 50952736 ↗
• MalfunctionSep 30, 2026No Apparent Adverse Event

  Patient problems: Arrhythmia

  MAUDE report 50952256 ↗
• InjurySep 30, 2026Difficult to Fold, Unfold or Collapse; Capturing Problem; Device Dislodged or Dislocated

  It was reported that a stable inpatient was brought to electrophysiology lab for a lead revision. Prior to the procedure, it was confirmed via chest X-ray imaging that there was right atrial (RA) lead dislodgment with elevated capture thresholds. It was also observed that the right ventricular lead exhibited sensing and pacing anomalies. During the lead revision, the helix deployment of both leads was suspected to be inadequate. The leads were ultimately explanted, and replacement leads were implanted. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950951 ↗
• InjurySep 30, 2026Capturing Problem; Device Dislodged or Dislocated

  It was reported that the patient presented to the clinic with an elevated pacing threshold on the right atrial (RA) lead and was scheduled for a lead revision. During the revision procedure, fluoroscopic evaluation revealed micro-dislodgement of the RA lead. The RA lead was explanted and replaced on (b)(6) 2026. The patient was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945222 ↗
• MalfunctionSep 30, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented remotely via Merlin.net. It was noted that the right atrial lead exhibited noise over-sensing resulted in inappropriate mode switch and noise reversion. No intervention was performed, and the patient will continue to be monitored remotely. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942887 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital due to infection at the device site. The pacemaker, right atrial lead and right ventricular lead were explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50942772 ↗
• InjurySep 30, 2026Over-Sensing; Pacing Problem; Low impedance

  It was reported that the patient presented in the hospital for lead revision. The patient's right atrial (RA) lead exhibited over-sensed noise resulting in inappropriate automated mode switch (AMS) episodes. The RA lead impedance was additionally noted to be low, however remained stable well within the acceptable range. 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 50941947 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a follow-up in the clinic with infection at the implanted device pocket site and pocket erosion. The implantable cardioverter defibrillator was visible from the opened incision site of the implanted device pocket. The physician explanted the entire system ¿ implantable cardioverter-defibrillator, right ventricular lead, and atrial lead due to resolve the issue. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50933706 ↗
• InjurySep 29, 2026Over-Sensing; Device Dislodged or Dislocated

  It was reported that the patient presented in the clinic for a follow-up. Upon interrogation, the atrial lead exhibited far R oversensing. Further diagnostic imaging confirmed that the lead had become dislodged. The lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933376 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928510 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient¿s right atrial lead was capped and replaced on (b)(6) 2026 due to an unspecified issue. The patient's condition was not known.

  Patient problems: Insufficient Information

  MAUDE report 50927443 ↗
• InjurySep 28, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924230 ↗
• InjurySep 28, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient's pacemaker system was explanted and replaced with a dual leadless pacemaker due to twiddler's syndrome that was confirmed via X-ray imaging. As a result of the twiddling, loss of capture was observed on the right atrium. The patient was discharged post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921226 ↗
• InjurySep 28, 2026Signal Artifact/Noise; Failure to Sense

  It was reported that the patient presented with noise and failure to sense on the Right Atrial lead. The lead was capped and a new one was implanted on (b)(6) 2026. Patient condition unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917946 ↗
• MalfunctionSep 28, 2026Failure to Capture; Retraction Problem; Failure to Advance

  It was reported that the patient presented to the hospital for an implant procedure. During the procedure, the right atrial (RA) lead exhibited loss of capture at high output. Following multiple repositioning attempts, the RA lead helix could not be retracted, and the stylet could not be advanced into the lead. The RA lead was removed and replaced. The patient was reported to be in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911126 ↗
• InjurySep 28, 2026Device Sensing Problem; Device Dislodged or Dislocated

  New information received indicated that the Right Atrial (RA) lead had exhibited decreased sensing prior to dislodgement and increased sensing following dislodgement. An X-Ray was performed prior to the procedure, confirming RA lead dislodgement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910861 ↗
• InjurySep 28, 2026Over-Sensing

  It was reported that the patient¿s right ventricular (RV) lead exhibited noise oversensing. 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 50910769 ↗
• InjurySep 28, 2026Failure to Capture; Failure to Sense; Low impedance

  It was reported that the patient presented to clinic for a follow up. It was noted that the right atrial (RA) lead exhibited low out of range pacing impedance, failure to capture and failure to sense. The RA lead was capped and replaced on (b)(6) 2026. The patient condition was not known.

  Patient problems: Insufficient Information

  MAUDE report 50910705 ↗
• MalfunctionSep 28, 2026Failure to Capture

  It was reported that the patient presented for an implant procedure. During the procedure, it was noted that the right atrial (RA) lead failed to pace during threshold testing. The RA lead was not used. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910698 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's pacemaker, right atrial (RA) lead and right ventricular (RV) lead were explanted on (b)(6)2026 due to infection. Temporary pacemaker was placed until the infection was resolved; the patient was subsequently implanted with a new pacemaker system on (b)(6)2026. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50910665 ↗
• InjurySep 28, 2026Signal Artifact/Noise; Break

  It was reported that the patient¿s right atrial (RA) lead was found to have an insulation breach and exhibited noise. The RA lead was explanted. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910617 ↗
• InjurySep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905756 ↗
• MalfunctionSep 25, 2026Break; Over-Sensing; Pacing Problem

  During an in-clinic follow-up, sensing noise resulting in oversensing and inappropriate automatic mode switch (AMS) were observed on the atrial lead device. Provocative testing was performed and the lead noise was reproduced. Lead damage was suspected but not confirmed. No known intervention has been performed. The patient is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903012 ↗
• InjurySep 25, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that the patient presented at clinic and it was discovered that their right atrial (RA) lead was dislodged. The patient was transferred to the implant facility, and it was also noted that there was a failure to capture and failure to sense. The RA lead was explanted and successfully replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900151 ↗