Tendril™ STS (REF 2088TC-65)Recalls & reported problems

Summary

The FDA's MAUDE database contains 433 adverse event reports that list this exact device (DI 05414734505055), received between Aug 6, 2018 and Sep 17, 2026 — classified as 6 deaths, 197 injuries, 230 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (76 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 433 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Retraction Problem

  It was reported that the patient presented to the hospital for a scheduled implant procedure. During the procedure, the lead helix was unable to retract despite several attempts and using mulitple helix locking tools. The lead was removed and replaced. The patient remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798343 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with bacteremia. The physician explanted the entire system ¿ pacemaker, right ventricular lead and atrial lead due to infection. The patient status was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50791206 ↗
• InjurySep 14, 2026Failure to Capture; Low impedance

  It was reported that the patient presented to the Emergency Room (ER) experiencing syncope and asystole. Device interrogation revealed that the right ventricular (RV) lead exhibited loss of capture in both bipolar and unipolar configurations and decreased pacing impedance trend. Temporary pacemaker was placed; the RV lead was subsequently explanted and replaced with a high voltage lead for implantable cardioverter defibrillator upgrade due to low ejection fraction. No lead damage was visualized. The patient was in stable condition.

  Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure; Syncope/Fainting

  MAUDE report 50749420 ↗
• MalfunctionSep 2, 2026Retraction Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559049 ↗
• MalfunctionAug 28, 2026Over-Sensing

  It was reported that the patient presented remotely via Merlin.net. Upon review of the transmission, the right ventricular (RV) lead exhibited noise oversensing, which resulted in a high ventricular rate (HVR) episode. No intervention was performed to address the reported issue. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488805 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a clinical follow-up with a pocket infection. The patient experienced pain, and the pocket was noted to be swollen with suspected purulent drainage. The pacemaker, right atrial lead, and right ventricular lead were explanted and replaced with a dual-chamber leadless pacemaker. The patient remained in stable condition throughout the event.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50399725 ↗
• InjuryAug 21, 2026Signal Artifact/Noise; Failure to Advance

  It was reported that episodes of noise were observed on the right ventricular (RV) lead. During a surgical procedure, it was observed the stylet was unable to be inserted into the RV lead. The RV lead was explanted and replaced to resolve event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372314 ↗
• MalfunctionAug 21, 2026Signal Artifact/Noise

  It was reported that the patient was monitored remotely through a Merlin.net transmission. Evaluation of the transmission data revealed noise on the patient's right ventricular (RV) lead. No intervention was reported. The patient remained asymptomatic, and no adverse events were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50363556 ↗
• InjuryAug 11, 2026High impedance

  It was reported that, increased pacing impedance was noted on the lead. The lead was explanted and replaced to resolve this event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203458 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with a localized pocket infection at the device implantation site. Due to the infection, the physician elected to explant the pacemaker and the right ventricular (RV) lead on (b)(6) 2026. A replacement procedure was subsequently performed on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50153024 ↗
• MalfunctionJul 31, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50095625 ↗
• DeathJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPIRED DUE TO MULTISYSTEM ORGAN FAILURE, SEPTIC SHOCK, RIGHT MIDDLE CEREBRAL ARTERY (MCA) STROKE AND ILEUS. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Stroke/CVA; Unspecified Infection

  MAUDE report 25640454 ↗
• MalfunctionJun 22, 2026Retraction Problem; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE HELIX OF THE RIGHT VENTRICULAR (RV) LEAD WAS FAILED TO DISCONNECT. UNDER FLUOROSCOPIC OBSERVATION, IT APPEARED THAT THE HELIX COULD NOT BE FULLY RETRACTED. THE RV WAS IMPLANTED-INACTIVE AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588936 ↗
• MalfunctionJun 22, 2026Signal Artifact/Noise; High impedance; Capturing Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW UP. INTERROGATION OF THE PULSE GENERATOR REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, WHICH WAS REPRODUCIBLE AND HAD ELEVATED IMPEDANCE AND CAPTURE THRESHOLD VALUES. PER THE PHYSICIAN¿S ASSESSMENT, THE LEAD WAS NOTED TO BE KINKED. PROGRAMMING ADJUSTMENTS WERE MADE, AND THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573087 ↗
• InjuryJun 15, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSPECIFIED OVERSENSING LED TO PACING INHIBITION. THE RV LEAD WAS CAPPED AND REPLACED (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513707 ↗
• MalfunctionMay 22, 2026Break; Difficult to Fold, Unfold or Collapse; Failure to Advance

  DURING AN INITIAL IMPLANT PROCEDURE, THE HELIX OF THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO EXTEND. APON VISUAL INSPECTION, THE HELIX APPEARED TO BE DAMAGED DURING THE PROCEDURE. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED TO RESOLVE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25258240 ↗
• MalfunctionMay 12, 2026Break

  DURING AN INITIAL IMPLANT PROCEDURE, THE HELIX OF THE RIGHT VENTRICULAR (RV) LEAD WAS DAMAGED AFTER MULTIPLE ATTEMPTS TO POSITION THE LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153739 ↗
• MalfunctionMay 5, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING RESULTED IN PACING INHIBITION. IN-CLINIC LEAD ASSESSMENT AND PROGRAMMING CHANGES WERE SUGGESTED; NO CHANGES OR INTERVENTION WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25078214 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. IT WAS NOTED THAT THE PATIENT MANIPULATED THE INCISION AND APPLIED CREAMS, CONTRIBUTING TO INFECTION. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ PACEMAKER, RIGHT VENTRICULAR LEAD AND ATRIAL LEAD DUE TO INFECTION. A NEW PACEMAKER SYSTEM WAS REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 25076213 ↗
• InjuryApr 29, 2026Capturing Problem; Material Twisted/Bent

  IT WAS REPORTED THAT AN INCREASE IN THE CAPTURE THRESHOLD WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. A REVISION PROCEDURE WAS PERFORMED AND THE INSULATION ON THE RV LEAD WAS OBSERVED TO BE WRINKLED. AS A RESULT, THE RV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037012 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE HELIX OF THE RIGHT VENTRICULAR (RV) LEAD WAS DEFORMED UPON REMOVAL FROM THE PATIENT. AS A RESULT, THE RV LEAD WAS NOT USED AND WAS REPLACED WITH A NEW LEAD. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012566 ↗
• InjuryApr 27, 2026Break; Over-Sensing

  IT WAS REPORTED THAT, NOISE RESULTING IN OVERSENSING CAUSING PACING INHIBITION WAS REPORTED ON THE RIGHT VENTRICULAR (RV) LEAD. X-RAY IMAGING WAS PERFORMED; NO ANOMALIES WERE NOTED. THE RV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE THIS EVENT. AFTER THE RV LEAD WAS EXPLANTED, INSULATION DAMAGE WAS VISUALLY NOTED ON THE RV LEAD. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998981 ↗
• InjuryApr 23, 2026Failure to Capture; High impedance; Under-Sensing; Device Dislodged or Dislocated

  DURING AN IN-CLINIC FOLLOW UP, INCREASED PACING IMPEDANCE, INCREASED CAPTURE THRESHOLDS RESULTING IN LOSS OF CAPTURE, AND DECREASED SENSING RESULTING IN UNDER-SENSING WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. DISLODGEMENT OF THE RV LEAD WAS SUSPECTED BUT THIS WAS NOT CONFIRMED. THE RV LEAD WAS REVISED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965596 ↗
• MalfunctionApr 16, 2026Break; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD, AND UPON REMOVING THE LEAD, THE LEAD HELIX WAS NOTED TO HAVE OVER-TORQUED. THE LEAD WAS NOT USED, AND A NEW LEAD WAS IMPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904163 ↗
• MalfunctionApr 15, 2026Failure to Capture; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE LOW VOLTAGE LEAD EXHIBITED LOSS OF CAPTURE. THE LEAD HELIX FAILED TO EXTEND AFTER REPOSITIONING. THE LEAD WAS NOT USED AND REPLACED DURING THE PROCEDURE. PATIENT STATUS WAS NOT REPORTED.

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

  MAUDE report 24892057 ↗