Tendril™ ST (REF 1888TC-46)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,164 adverse event reports that list this exact device (DI 05414734501743), received between Jul 19, 2016 and Sep 10, 2026 — classified as 46 deaths, 575 injuries, 543 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (500 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 1,164 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Over-Sensing; Low impedance

  It was reported that the patient presented for a follow-up in clinic. Upon interrogation, it was noted that the right atrial (RA) lead exhibited low pacing impedance, noise over-sensing and myopotential over-sensing. The RA lead was explanted and replaced. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707713 ↗
• MalfunctionSep 9, 2026Difficult to Remove

  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 50685314 ↗
• InjurySep 8, 2026Break; Over-Sensing; Pacing Problem; Low impedance

  It was reported that the patient presented to the hospital for a device changeout procedure. Prior to the procedure, it was noted that the right atrial (RA) lead exhibited oversensing noise resulting in inappropriate mode switch, low pacing impedance. During the procedure, it was noted that both the RA and right ventricular (RV) leads had compromised outer insulation and exposed wire. Both the RA and RV leads were repaired and remained implanted. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50659283 ↗
• InjuryAug 19, 2026Break; Failure to Capture; High impedance

  It was reported that the atrial lead exhibited high pacing impedance and failed to capture when pacing at high outputs. During the procedure, the physician observed evidence of insulation damage on the atrial lead. When attempting to reconnect the existing atrial lead to the replacement pulse generator, high impedance was again noted on the atrial lead, and capture could not be achieved even at high pacing outputs. Subsequently, the atrial lead was capped on (b)(6) 2026 and replaced. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50315829 ↗
• MalfunctionAug 18, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented for a follow up in clinic. It was note that the right atrial lead exhibited noise over-sensing which resulted in inappropriate mode switch. No intervention was performed and will continue to be monitored. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50294194 ↗
• InjuryAug 5, 2026Over-Sensing; Failure to Sense

  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 50137907 ↗
• InjuryJun 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD WAS CAPPED ON (B)(6) 2026 FOR AN UNKNOWN REASON. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25588884 ↗
• MalfunctionJun 16, 2026No Apparent Adverse Event

  THIS REPORT IS TO ADVISE OF A FAILURE EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 25520529 ↗
• InjuryJun 15, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT BOTH REMOTE TRANSMISSION REVIEW AND IN-CLINIC DEVICE INTERROGATION INDICATED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING RESULTED IN INAPPROPRIATE MODE SWITCHES, WHILE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLD. BOTH THE RA & RV LEADS WERE CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498228 ↗
• InjuryJun 11, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR LEAD REVISION. THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING, RESULTING IN LOSS OF CAPTURE. 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 25466575 ↗
• InjuryMay 25, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE ATRIAL LEAD EXHIBITED MYOPOTENTIALS OVERSENSING THAT 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 25271469 ↗
• MalfunctionMay 18, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT ATRIAL LEAD NOISE, OVERSENSING AND AUTO MODE SWITCHING (AMS) WAS HISTORICALLY OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. OTHER PARAMETERS WERE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210267 ↗
• MalfunctionMay 16, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, IT WAS NOTED THAT THE ATRIAL LEAD EXHIBITED FAR R OVERSENSING RESULTING IN AN INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). THE PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25195129 ↗
• InjuryMay 11, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION. THE RA LEAD WAS EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133935 ↗
• MalfunctionMay 10, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR LEAD EXTRACTION PROCEDURE. PRE-OPERATIVE TESTING SHOWED MULTIPLE NOISE REVERSIONS. STORED ELECTROGRAMS (EGMS) DEMONSTRATED THAT THE PACEMAKER, RIGHT ATRIAL (RA) LEAD, AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION AND INAPPROPRIATE MODE SWITCH. THE PACEMAKER AND THE RV LEAD WERE EXPLANTED AND REPLACED, WHILE THE RIGHT ATRIAL (RA) LEAD REMAINED IMPLANTED AFTER THE REOPERATION WAS COMPLETED. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133419 ↗
• MalfunctionApr 16, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN HIGH VENTRICULAR RATE (HVR) EPISODES. NO INTERVENTION WAS PERFORMED. THE RV LEAD AND RA LEAD WILL BE FURTHER MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902233 ↗
• InjuryApr 16, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE ATRIAL LEAD EXHIBITED NOISE OVERSENSING, WHICH RESULTED IN PACING INHIBITION AND INAPPROPRIATE AUTOMATIC MODE SWITCHING (AMS). THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24892491 ↗
• MalfunctionApr 15, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. NO INTERVENTIONS OR CHANGES WERE REPORTED. THE PATIENT'S CONDITION WAS UNKNOWN.

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

  MAUDE report 24881089 ↗
• MalfunctionApr 13, 2026Signal Artifact/Noise; Over-Sensing

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS PRESENTED REMOTELY. UPON REVIEW, THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE OVERSENSING WHICH LED TO PACING INHIBITION. NO INTERVENTION WAS MADE. THE PATIENT WAS STABLE.

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

  MAUDE report 24854102 ↗
• MalfunctionMar 5, 2026No Apparent Adverse Event

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 24517957 ↗
• MalfunctionFeb 22, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR SYNCOPE. UPON INTERROGATION, THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE EPISODES. THE RA LEAD EXHIBITED OVER-SENSED NOISE RESULTING IN INAPPROPRIATE AUTOMATED MODE SWITCH (AMS) EPISODES. PROGRAMMING CHANGES WERE MADE TO HAVE THE RIGHT VENTRICULAR (RV) LEAD SENSITIVITY ADJUSTED TO AVOID NOISE OVER-SENSING. THE PATIENT WILL BE CONTINUED TO BE MONITORED AND WAS IN A STABLE CONDITION.

  Patient problems: Syncope/Fainting

  MAUDE report 24410908 ↗
• MalfunctionFeb 19, 2026Insufficient Device Problem Information

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 24391350 ↗
• InjuryFeb 19, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A GENERATOR CHANGE PROCEDURE. UPON INTERROGATION, THE ATRIAL LEAD AND RIGHT VENTRICLE LEAD EXHIBITED NOISE THAT WAS OVERSENSED BY THE DEVICE. BOTH ATRIAL LEAD AND VENTRICLE LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388905 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL EXPERIENCING FEVER AND FATIGUE. UPON REVIEW, IT WAS NOTED THAT THE PATIENT HAD AN INFECTION. ECHOCARDIOGRAM WAS PERFORMED AND REVEALED VEGETATION ON THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD WAS EXPLANTED AND REPLACED. THERE WAS NO ALLEGATION FROM THE PHYSICIAN THAT THE INFECTION WAS ABBOTT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS RECOVERING.

  Patient problems: Fatigue; Fever; Unspecified Infection

  MAUDE report 24300010 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT THE PATIENT'S NOTIFIER WAS TRIGGERED DUE TO HIGH CAPTURE THRESHOLDS ON THE LEFT VENTRICULAR (LV) LEAD. THE PATIENT WAS SCHEDULED FOR AN EXTRACTION. DURING THE PROCEDURE, AN INSULATION BREACH WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE RV LEAD CAME OUT AS A RESULT OF THE LV EXTRACTION. NO MALFUNCTION WAS STATED ON THE RV LEAD. THE RA LEAD WAS EXTRACTED. ALL LEADS WERE REPLACED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135997 ↗