Tendril™ STS (REF 2088TC-58)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12,708 adverse event reports that list this exact device (DI 05414734502894), received between Jun 11, 2018 and Sep 30, 2026 — classified as 200 deaths, 6,346 injuries, 6,162 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (3,356 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 12,708 reports, 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 ↗
• 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 ↗
• 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, 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, 2026Signal Artifact/Noise; Low impedance

  It was reported that the patient presented to the hospital for a right ventricular (RV) lead extraction procedure due to noise and low pacing impedance measurements. The RV lead was explanted and replaced. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942609 ↗
• MalfunctionSep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941401 ↗
• InjurySep 28, 2026Failure to Sense; Capturing Problem; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926693 ↗
• InjurySep 28, 2026Device 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 50921247 ↗
• MalfunctionSep 28, 2026Difficult to Fold, Unfold or Collapse

  It was reported that during a patient procedure the lead's helix retracted and could not be unscrewed. The lead was not used, and a new lead was implanted satisfactorily. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917626 ↗
• InjurySep 28, 2026Low impedance

  It was reported that the patient presented to clinic for follow up, the right ventricle (RV) lead exhibited low pacing impedance. The RV lead was capped and replaced on (b)(6)2026. The patient was discharged with no reports of adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910951 ↗
• 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 50910896 ↗
• InjurySep 28, 2026Signal Artifact/Noise; Failure to Capture

  It was reported that the patient presented to the hospital for a scheduled device exchange procedure. Interrogation of the pulse generator noted that the right ventricular (RV) lead exhibited noise episodes while in unipolar configuration. Further test performed on the lead in bipolar configuration, and the lead exhibited no capture. The lead was capped and replaced on the same procedure on (b)(6)2026. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910792 ↗
• MalfunctionSep 28, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited oversensing of suspected electromagnetic interference (EMI) noise. No intervention was reported. There were no patient symptoms reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910760 ↗
• 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 50910672 ↗
• MalfunctionSep 28, 2026Difficult to Fold, Unfold or Collapse

  It was reported that the patient presented for an implant procedure. During the procedure, the helix of the lead failed to extend. As a result, the lead was not implanted and was replaced during the same procedure. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910649 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  It was reported that the patient's pacemaker was explanted due to an unknown reason and the right ventricular (RV) lead was explanted due an unspecified lead failure. A replacement RV lead was implanted. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897906 ↗
• MalfunctionSep 25, 2026Difficult to Remove

  It was reported that the patient presented to hospital for a generator change procedure. During the procedure, it was noted that the right ventricular (RV) lead could not be removed from the pacemaker despite multiple attempts. Additional manipulation of the RV lead was performed, and the RV lead was subsequently removed from the pacemaker. The pacemaker was explanted and replaced, while the RV lead remained implanted. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894371 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the clinic with redness and swelling at the implant pocket site secondary to an infection. The physician elected to explant the entire system, including the pacemaker, right ventricular (RV) lead, and right atrial (RA) lead, on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50893665 ↗
• MalfunctionSep 24, 2026Break; Over-Sensing

  During an in clinic follow up, noise resulting in oversensing was noted on the right ventricular (RV) lead. RV lead damage was suspected but this was not confirmed. provocative maneuvers were performed; no anomalies were noted. No intervention has been performed. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884950 ↗
• InjurySep 24, 2026Fracture; High impedance

  It was reported that high pacing impedance was noted on the right ventricular (RV) lead. Lead fracture was observed. The RV lead was capped and replaced on (b)(6) 2026. There were no adverse events to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884018 ↗
• InjurySep 24, 2026High impedance; Capturing Problem

  It was reported that the patient presented to the clinic for a scheduled follow-up. Upon interrogation, the patient's right ventricular (RV) lead exhibited a high capture threshold and high pacing impedance. The RV lead was explanted and replaced on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878350 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient presented to clinic with fever and chills. The patient experienced an adverse event of infection. The reported infection was determined not to be associated with any Abbott product or procedure. Blood cultures were obtained and positive for Staphylococcus bacteremia. Due to the infection, the pacemaker (PM), the right ventricle (RV) and atrial leads were explanted. The cause of the infection was attributed to Staphylococcus bacteremia.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50877501 ↗
• MalfunctionSep 24, 2026Failure to Capture

  It was reported that during an implant procedure, the lead exhibited elevated pacing thresholds and failed to achieve capture despite programming at high pacing outputs. Lead repositioning was attempted; however, no improvement in electrical performance was observed. The physician elected to not use the lead, and a new lead was implanted. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877321 ↗