Tendril™ SDX (REF 1688TC-52)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,464 adverse event reports that list this exact device (DI 05414734501859), received between Jun 11, 2018 and Sep 29, 2026 — classified as 49 deaths, 894 injuries, 521 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (423 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 1,464 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented to the clinic. Upon device interrogation, the right atrial (RA) lead exhibited noise oversensing, which resulted in inappropriate Auto Mode Switch (AMS) episodes. As a result, the RA lead was capped and replaced on (b)(6) 2026. The patient remained stable throughout the procedure, and no adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927468 ↗
• InjurySep 11, 2026Break; Low impedance

  It was reported that the patient presented for a clinical follow-up evaluation. Upon assessment, the right ventricular (RV) lead exhibited low pacing impedance. Based on the observed electrical findings, the RV lead was suspected of having an insulation breach. On (b)(6) 2026, the RV lead was capped and replaced. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726411 ↗
• MalfunctionSep 10, 2026Failure to Disconnect

  It was reported that the patient presented to hospital for a generator change procedure. During the procedure, it was reported that the set screw of the right atrial (RA) lead was stripped resulting in the RA lead unable to remove from the header of the pacemaker. The RA lead was capped and the pacemaker was explanted. The patient was discharged post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50708091 ↗
• InjurySep 8, 2026High impedance

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission indicated that the right ventricular (RV) lead exhibited abnormally high pacing impedance. The RV lead was capped and replaced on (b)(6) 2026. The patient was discharged following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50662206 ↗
• MalfunctionAug 28, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented for a follow-up in clinic. Interrogation revealed that the right atrial (RA) lead exhibited two episodes of noise over-sensing which resulted in inappropriate mode switching. The noise on the RA lead was not reproducible. No intervention or changes were performed, and the RA lead will continue to be monitored. The patient was asymptomatic and remained in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50490895 ↗
• MalfunctionJun 23, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. TRANSMISSION SHOWED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION. THE RA LEAD WILL BE FURTHER MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25589818 ↗
• InjuryJun 17, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING RESULTED IN PACING INHIBITION. THE RA LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541783 ↗
• InjuryJun 10, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. 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 25452769 ↗
• MalfunctionMay 29, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THROUGH A REMOTE TRANSMISSION THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED FAR R-WAVE OVER-SENSING RESULTED IN INAPPROPRIATE MODE SWITCH EPISODES. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25329288 ↗
• MalfunctionMay 20, 2026Intermittent Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. IN CLINIC THRESHOLD ASSESSMENT AND PROGRAMMING CHANGES WAS SUGGESTED; NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230276 ↗
• InjuryMay 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR A FOLLOW UP. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE RESULTING IN PACING INHIBITION. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211614 ↗
• InjuryMay 18, 2026Break; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH PACING IMPEDANCE AND LEAD INTEGRITY ISSUE WAS SUSPECTED. MILD VALVULAR REGURGITATION WAS NOTED. THE ATRIAL LEAD SHOWED OVERSENSING DUE TO NOISE. BOTH LEADS WERE CAPPED ON (B)(6) AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25208955 ↗
• InjuryMay 12, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOISE RESULTING IN INAPPROPRIATE MODE SWITCH. THE RA LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146601 ↗
• InjuryMay 10, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. THE RA LEAD WAS SUBSEQUENTLY CAPPED AND REPLACED ON (B)(6) 2026 DUE TO NOISE AND PERMANENT ATRIAL FIBRILLATION (AF). THE PATIENT WAS LATER DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133624 ↗
• InjuryMay 5, 2026Break; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT ATRIAL (RA) LEAD EXHIBITED NON-REPRODUCIBLE NOISE AND POLARITY SWITCH DUE TO LOW PACING IMPEDANCE. THE CLINICIAN SUSPECTED THAT THE NOISE WAS OVERSENSED AND INSULATION BREACH FOUND ON THE RA LEAD. 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 25089423 ↗
• MalfunctionMay 3, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25064097 ↗
• InjuryApr 24, 2026Fracture; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER-SENSING AND FRACTURE WAS SUSPECTED. THE PHYSICIAN CAPPED AND REPLACED THE RV LEAD. THERE WERE NO PATIENT CONSEQUENCES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984673 ↗
• MalfunctionApr 20, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 24933490 ↗
• MalfunctionApr 17, 2026Over-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN HOSPITAL FOR GENERATOR CHANGEOUT PROCEDURE. DURING THE PROCEDURE, THE RIGHT ATRIAL (RA) LEAD EXHIBITED R-WAVE OVERSENSING. FLUOROSCOPY CONFIRMED THE RA LEAD DISLODGMENT. ON (B)(6) 2026, THE PHYSICIAN ELECTED TO CAP THE RA LEAD AND REPLACE IT WITH A NEW ONE. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24917393 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FEELING A PAIN SENSATION WHICH LED TO DISCOMFORT DUE TO POCKET IRRITATION. THE PHYSICIAN DECIDED TO EXPLANT THE PACEMAKER, RIGHT ATRIAL (RA) LEAD, AND RIGHT VENTRICULAR (RV) LEAD. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Discomfort

  MAUDE report 24854362 ↗
• InjuryMar 23, 2026Over-Sensing; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A PROCEDURE. DEVICE INTERROGATION REVEALED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE, HIGH CAPTURE THRESHOLD, OUT-OF-RANGE AND LOW DEFIBRILLATION IMPEDANCE. INTERROGATION ALSO SHOWED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOISE AND HIGH CAPTURE THRESHOLD. ON (B)(6) 2026, THE PHYSICIAN ELECTED TO TURN OFF THERAPY AND PACING OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), CAP THE RV AND RA LEADS ON THE LEFT SIDE, AND IMPLANT A NEW ICD ALONG WITH NEW RV AND RA LEADS ON THE RIGHT SIDE. THE PATIENT¿S CONDITION REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671397 ↗
• InjuryMar 15, 2026Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, THE RIGHT VENTRICLE LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND DECREASE IN R WAVE AMPLITUDE. THE 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 24601622 ↗
• InjuryMar 11, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE ATRIAL LEAD EXHIBITED NOISE THAT WAS OVERSENSED BY THE DEVICE. THE 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 24566236 ↗
• DeathMar 4, 2026Adverse Event Without Identified Device or Use Problem

  VOLUNTARY MEDWATCH RECEIVED STATES THAT THE PATIENT DIED. THE PATIENT HAD A RIGHT ATRIAL (RA) LEAD IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513439 ↗
• MalfunctionFeb 17, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT ATRIAL OVERSENSING WAS NOTED ON THE DEVICE. ADDITIONALLY, NOISE AND FAR R OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD AND LOSS OF CAPTURE AND NOISE WERE SEEN ON THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTION WAS MADE AT THIS TIME. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364485 ↗