TendrilRecalls & reported problems across all models

We found 15 models of Tendril by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 49,498 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2016 and Sep 30, 2026 — classified as 1,103 deaths, 26,960 injuries, 21,434 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (14,187 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Tendril problems

Tendril models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tendril™ STS

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  438 deaths19,632 reports
• Tendril™ STS

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  200 deaths12,708 reports
• Tendril™ STS

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  190 deaths6,776 reports
• Tendril™ ST

  Permanent defibrillator electrodes
  74 deaths3,093 reports
• Tendril™ ST

  Permanent defibrillator electrodes
  21 deaths1,673 reports
• Tendril™ SDX

  permanent pacemaker Electrode
  49 deaths1,464 reports
• Tendril™ ST

  Permanent defibrillator electrodes
  46 deaths1,164 reports
• Tendril™ SDX

  permanent pacemaker Electrode
  34 deaths800 reports
• Tendril™ SDX

  permanent pacemaker Electrode
  12 deaths766 reports
• Tendril™ ST

  Permanent defibrillator electrodes
  15 deaths547 reports
• Tendril™ STS

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  6 deaths433 reports
• Tendril™ ST

  Permanent defibrillator electrodes
  16 deaths398 reports
• Tendril™ STS

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  23 reports
• Tendril™ SDX

  permanent pacemaker Electrode
  2 deaths18 reports
• Tendril™ SDX

  permanent pacemaker Electrode
  3 reports

Recent Tendril adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Remove

  New information received notes that the patient presented to the hospital for a generator changeout procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955162 ↗
• InjurySep 30, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955153 ↗
• MalfunctionSep 30, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955147 ↗
• MalfunctionSep 30, 2026Over-Sensing

  Patient problems: Dizziness

  MAUDE report 50953561 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 30, 2026Over-Sensing

  During an in-clinic follow up, sensing noise was observed on the right ventricular (RV) Lead. The patient is pacer dependent. No intervention has been performed at this time. The patient is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947200 ↗
• MalfunctionSep 30, 2026Break; Retraction Problem

  It was reported that the patient presented for an implant procedure. During the implant procedure the physician needed to reposition the lead, but the helix was unable to be retracted when fixated in the myocardium. The lead was pulled from the heart, and it was noted that the helix was deformed and broken. The lead was replaced with a new lead and procedure was completed successfully. Patient was discharged following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946866 ↗
• 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 50942775 ↗
• 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, 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 ↗

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