Tendril™ ST (REF 1882TC-52)Recalls & reported problems

Summary

The FDA's MAUDE database contains 547 adverse event reports that list this exact device (DI 05414734501699), received between Jun 11, 2018 and Sep 15, 2026 — classified as 15 deaths, 229 injuries, 303 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (251 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 547 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780855 ↗
• InjurySep 8, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented for a generator change procedure. Prior to the procedure, it was noted that the right atrial (RA) lead exhibited noise over-sensing which resulted in inappropriate 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 50659722 ↗
• MalfunctionSep 1, 2026Signal Artifact/Noise

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed that both the right ventricular (RV) and right atrial (RA) leads exhibited electromagnetic interference (EMI). No intervention or changes were performed. The patient remained in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50534694 ↗
• InjuryAug 20, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented for a follow up in clinic. It was noted that the right atrial lead exhibited noise over-sensing which resulted in inappropriate mode switch. The lead was capped and replaced on (b)(6) 2026. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50336059 ↗
• InjuryAug 19, 2026Over-Sensing

  It was reported that the system was explanted and replaced due to oversensing noise leading to inappropriate shock. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50327756 ↗
• MalfunctionAug 8, 2026No Apparent Adverse Event

  This report is to advise of an event observed during analysis. Degradation problem.

  Patient problems: Insufficient Information

  MAUDE report 50184554 ↗
• InjuryJun 29, 2026High impedance; Over-Sensing; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. INTERROGATION REVEALED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN INCREASED CAPTURE THRESHOLD, HIGH PACING IMPEDANCE AND NOISE OVER-SENSING. THE HIGH PACING IMPEDANCE HAD PREVIOUSLY BEEN IDENTIFIED AT ANOTHER FACILITY. DUE TO THE ELEVATED CAPTURE THRESHOLD, THE DEVICE WAS PROGRAMMED TO VDD MODE. THE RA LEAD WAS SUBSEQUENTLY CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT REMAINED STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661726 ↗
• InjuryApr 14, 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 NOISE OVER-SENSING. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS LATER DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868596 ↗
• InjuryApr 2, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT IN THE CLINIC. THE TRANSMISSIONS SHOWED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING, WHICH RESULTED IN PACING INHIBITION AND EPISODES OF INAPPROPRIATE MODE SWITCHING. PROGRAMMING CHANGES WERE MADE. THE RA LEAD WAS CONNECTED TO THE NEW PACEMAKER DURING THE DEVICE DOWNGRADE PROCEDURE ON (B)(6) 2026. THE PATIENT REMAINED IN STABLE CONDITION BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762584 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  VOLUNTARY MEDWATCH RECEIVED STATES THE PATIENT'S RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO INFECTION. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24648184 ↗
• InjuryJan 30, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT PATIENT PRESENTED TO CLINIC FOR ELECTIVE REPLACEMENT INDICATOR (ERI) GENERATOR CHANGE PROCEDURE, DURING INTERROGATION THE ATRIAL LEAD EXHIBITED NOISE OVER SENSING RESULTED IN AN INAPPROPRIATE MODE SWITCH. HENCE, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE ATRIAL LEAD ON (B)(6) 2026. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219048 ↗
• MalfunctionJan 20, 2026Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED PACEMAKER GENERATOR REPLACEMENT. DURING THE PROCEDURE, THE PACEMAKER¿S SET SCREWS FAILED TO RELEASE, RESULTING IN BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS BECOMING STUCK WITHIN THE DEVICE PORTS. MULTIPLE ATTEMPTS WERE MADE BY THE PHYSICIAN TO RELEASE THE SET SCREWS; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN ELECTED TO CUT THE PACEMAKER HEADER. THE RV AND RA LEADS WERE THEN CAPPED. A NEW CARDIAC PACING SYSTEM WAS IMPLANTED DURING THE SAME PROCEDURE. THE PATIENT REMAINED IN STABLE CONDITION THROUGHOUT THE PROCEDURE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126863 ↗
• InjuryDec 9, 2025Failure to Capture; Fracture; Low impedance; Failure to Capture; Fracture; Low impedance

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT FLUOROSCOPY WAS USED TO CONFIRM FRACTURE OF THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760044 ↗
• MalfunctionDec 2, 2025Break; Over-Sensing; Pacing Problem; Break; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT, OVERSENSING AND INAPPROPRIATE AUTOMATIC MODE SWITCH WERE OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. RA LEAD DAMAGE WAS SUSPECTED BUT THIS WAS NOT CONFIRMED. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693421 ↗
• InjuryDec 1, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. BOTH DEVICE INTERROGATION AND REMOTE TRANSMISSION REVEALED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING RESULTING IN INAPPROPRIATE MODE SWITCH. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689296 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW INFORMATION RECEIVED NOTES THAT INFECTION WAS ALSO NOTED, AND THE NECROTIC TISSUE WAS REMOVED FROM THE POCKET AS WELL.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23660694 ↗
• InjuryNov 26, 2025Over-Sensing; Over-Sensing

  NEW INFORMATION RECEIVED STATES THAT THE OVER SENSED NOISE ON THE LEAD CAUSED PACING INHIBITION, AS A RESULT ON (B)(6) 2026 A SURGICAL PROCEDURE WAS DONE TO CAP THE LEAD AND REPLACE IT, THE PATIENT CONDITION WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659225 ↗
• InjuryNov 7, 2025Signal Artifact/Noise; Break; Low impedance; Signal Artifact/Noise; Break; Low impedance

  IT WAS REPORTED THAT INSULATION DAMAGE WAS NOTED ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE INSULATION DAMAGED CAUSED LOW PACING IMPEDANCE AND NOISE. THE LEADS WERE BOTH EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498279 ↗
• InjuryOct 30, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT PRIOR TO A GENERATOR CHANG-OUT, NOISE WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THIS LED TO OVERSENSING AND INAPPROPRIATE MODE SWITCHING (AMS). THE LEAD WAS CAPPED ON (B)(6) 2025 AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429909 ↗
• MalfunctionOct 16, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  NEW INFORMATION RECEIVED NOTES THAT THE PATIENT WAS PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE NOISE WAS OVER-SENSED ON THE RIGHT ATRIAL LEAD. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 23319457 ↗
• MalfunctionSep 2, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW UP. INTERROGATION OF THE PULSE GENERATOR NOTED THAT THE RIGHT ATRIAL (RA) LEAD WAS OVER-SENSING NOISE RESULTED IN INAPPROPRIATE MODE SWITCH EPISODES. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935455 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH BACTEREMIA AND WAS EXPERIENCING FEVER AND SHORTNESS OF BREATH. VEGETATION ON THE RIGHT ATRIAL LEAD WAS VISUALIZED USING A TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PHYSICIAN EXPLANTED THE SYSTEM ¿ PACEMAKER, RIGHT ATRIAL LEAD AND RIGHT VENTRICLE LEAD. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Dyspnea; Fever; Unspecified Infection

  MAUDE report 22735385 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH AN UPPER RESPIRATORY TRACT INFECTION. ECHOCARDIOGRAM PERFORMED NOTED ENDOCARDITIS WITH LEAD VEGETATION AND A MOBILE MASS ATTACHED TO THE RIGHT ATRIAL (RA) LEAD. BOTH THE RA LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO THE ENDOCARDITIS AND LEAD VEGETATION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 22325085 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH INFECTION AND EROSION AT THE DEVICE SITE. THE INFECTION WAS NOT ASSOCIATED WITH ANY ABBOTT PRODUCT AND/OR PROCEDURE, THE PACEMAKER, RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 22173655 ↗
• InjuryMay 5, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED GENERATOR CHANGEOUT. THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD BEEN PREVIOUSLY TURNED OFF DUE TO NON-CAPTURE AT MAX OUTPUT AFTER AN OPEN-HEART SURGERY IN (B)(6) 2024. PRE-PROCEDURE INTERROGATION REVEALED NORMAL MEASUREMENTS ON ALL TESTS BUT HIGH CAPTURE THRESHOLD ON THE RA LEAD. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RA LEAD ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965237 ↗