Tendril™ SDX (REF 1688TC-46)Recalls & reported problems

Summary

The FDA's MAUDE database contains 800 adverse event reports that list this exact device (DI 05414734501989), received between Jun 11, 2018 and Sep 18, 2026 — classified as 34 deaths, 477 injuries, 289 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (267 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 800 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Failure to Disconnect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831566 ↗
• InjurySep 10, 2026Failure to Capture; Over-Sensing; Pacing Problem

  It was reported that the patient's right atrial (RA) lead had failed to capture and was over-sensing noise resulted in inappropriate mode switch episodes. The lead was explanted and replaced. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50706768 ↗
• InjuryAug 20, 2026Failure to Capture

  It was reported that patient recently underwent cardiothoracic surgery and presented to clinic for follow up evaluation. During device assessment, the atrial lead was found to be non-capturing. No damage on atrial lead seen on fluoroscopy. Subsequently, the atrial was capped and replaced by the physician on (b)(6) 2026. The patient was discharged with no reports of adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50337670 ↗
• MalfunctionAug 19, 2026Failure to Capture; Failure to Sense

  It was reported that the patient presented for a follow-up in clinic. The hospital nurse noted atrial pacing spikes on the electrocardiogram (EKG) with no capture and requested for device interrogation. Interrogation revealed that the right atrial (RA) lead exhibited loss of atrial sensing. The device was reprogrammed to VVI mode due to chronic atrial fibrillation and to address the issue. The patient remained in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50312316 ↗
• InjuryAug 6, 2026Failure to Capture; Device Sensing Problem

  It was reported that the patient presented for a scheduled lead replacement procedure. The patient's right atrial (RA) lead was noted to exhibit poor atrial sensing and 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 50151640 ↗
• InjuryJun 29, 2026Over-Sensing; Pacing Problem; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING WHICH CAUSED INAPPROPRIATE AUTOMATIC MODE SWITCH AND POCKET STIMULATION. AFTER DISCOVERY, PROGRAMMING CHANGES WERE MADE ON THE RV LEAD. THE RV LEAD WAS LATER CAPPED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Discomfort

  MAUDE report 25660000 ↗
• MalfunctionJun 23, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25602892 ↗
• InjuryJun 23, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A GENERATOR REPLACEMENT PROCEDURE. DEVICE INTERROGATION PRIOR TO THE PROCEDURE REVEALED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING RESULTED IN FALSE MODE SWITCH. 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 25589792 ↗
• MalfunctionJun 11, 2026Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS REMOTELY MONITORED VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, THE ATRIAL LEAD DEMONSTRATED ELEVATED PACING IMPEDANCE AND NOISE. NO INTERVENTION WAS PERFORMED. THE PATIENT¿S STATUS WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25480874 ↗
• MalfunctionJun 8, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOISE RESULTING IN AUTOMATED MODE SWITCH (AMS) EPISODES. THE NOISE WAS NOT REPRODUCIBLE WITH ISOMETRIC EXERCISE. PROGRAMMING CHANGES ON THE SENSITIVITY WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427268 ↗
• MalfunctionJun 8, 2026Intermittent Capture; High impedance; Over-Sensing

  VOLUNTARY MEDWATCH RECEIVED STATES THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE, NOISE OVERSENSING AND INTERMITTENT LOSS OF CAPTURE. NO CHANGES OR INTERVENTIONS WERE REPORTED; THE RV LEAD REMAINED IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423578 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO INFECTION. VEGETATION WAS IDENTIFIED ON THE RIGHT VENTRICULAR (RV) LEAD, PREVIOUSLY CAPPED RV LEAD, RIGHT ATRIAL (RA) LEAD, AND PREVIOUSLY CAPPED RA LEAD. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM, INCLUDING THE PACEMAKER AND ALL ASSOCIATED LEADS. A NEW LEADLESS DUAL-CHAMBER PACEMAKER WAS IMPLANTED. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 25423040 ↗
• MalfunctionJun 5, 2026Break; Over-Sensing; Pacing Problem; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET.UPON REVIEW OF THE TRANSMISSION, IT WAS NOTED THAT THE ATRIAL LEAD EXHIBITED NOISE OVERSENSING, RESULTING IN AN INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS) AND PACING INHIBITION. ADDITIONALLY, LOW PACING IMPEDANCE WAS OBSERVED, WHICH MAY BE INDICATIVE OF INSULATION DAMAGE. INTERMITTENT INHIBITION MAY ALSO OCCUR DUE TO THE DEVICE SENSING THE NOISE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403698 ↗
• MalfunctionMay 21, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A SHARP JUMP IN PACING IMPEDANCE, INDICATIVE OF POTENTIAL LEAD FRACTURE. NO INTERVENTION WAS MADE, AND NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250821 ↗
• MalfunctionMay 14, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. NO INTERVENTIONS OR CHANGES WERE REPORTED AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25168102 ↗
• InjuryMay 6, 2026Capturing Problem

  IT WAS DISCOVERED THROUGH ROUTINE DEVICE MONITORING THAT THE ATRIAL LEAD CAPTURE THRESHOLD HAD INCREASED. THE LEAD WAS EXTRACTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093003 ↗
• DeathMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085899 ↗
• DeathMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25081513 ↗
• MalfunctionMay 5, 2026Break; Failure to Capture; Over-Sensing; Low impedance

  VOLUNTARY MEDWATCH RECEIVED STATES THAT THE PATIENT EXPERIENCED ARRHYTHMIA AND PALPITATIONS. THE ATRIAL LEAD EXHIBITED LOW PACING IMPEDANCE, NOISE OVERSENSING, AND FAILURE TO CAPTURE. THE PHYSICIAN SUSPECTED INSULATION DAMAGE. PROGRAMMING CHANGES WERE MADE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 25077071 ↗
• InjuryMay 5, 2026Insufficient Device Problem Information

  VOLUNTARY MEDWATCH RECEIVED STATES A PATIENT'S IMPLANTABLE LEAD WAS CAPPED DUE TO A PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076952 ↗
• MalfunctionApr 27, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25000842 ↗
• InjuryApr 22, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. UPON DEVICE INTERROGATION, THE ATRIAL LEAD EXHIBITED HIGH PACING IMPEDANCE. THE ATRIAL LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961309 ↗
• DeathApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE CAUSE OF DEATH WAS DUE TO MULTI-ORGAN FAILURE AND CARDIOGENIC SHOCK. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913392 ↗
• 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 LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24892540 ↗
• 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 24854336 ↗