Tendril MRI™ LPA1200M-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,915 adverse event reports that list this exact device (DI 05414734504621), received between Jun 12, 2018 and Sep 30, 2026 — classified as 111 deaths, 1,730 injuries, 1,074 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (804 reports).

5 other recalls cover devices cleared under the same FDA submission (P140033); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,915 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had bacteremia and their Implantable Cardioverter Defibrillator (ICD), right ventricular (RV) lead, right atrial (RA) lead, and left ventricular (LV) lead were explanted as a result. The patient was stable.

  Patient problems: Unspecified Infection

  MAUDE report 50951655 ↗
• InjurySep 30, 2026Failure to Capture; High impedance; Device Dislodged or Dislocated

  It was reported that patient presented to healthcare facility. Upon interrogation it was noted that the atrial lead had high pacing impedance and was not capturing properly. Chest X-Ray was performed and it was discovered that the atrial lead had dislodged. On (b)(6) 2026, the physician elected to cap and replace the atrial lead. The patient was stable following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945527 ↗
• InjurySep 29, 2026Over-Sensing

  It was reported that the patient presented in clinic for generator changeout procedure on (b)(6) 2026. Upon interrogation, it was found that the right ventricular (RV) and right atrial (RA) leads exhibited noise over-sensing, and both over-sensing of electromagnetic interference causing inappropriate automatic mode switch and pacing inhibition were further noted on the RA lead. The pacemaker was alleged for noise over sensing. The pacemaker was explanted and replaced, but both leads remained implanted and active. Patient condition was stable the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927933 ↗
• MalfunctionSep 25, 2026Over-Sensing; Pacing Problem

  Patient problems: Insufficient Information

  MAUDE report 50892700 ↗
• InjurySep 24, 2026Capturing Problem

  It was reported that the patient's right atrial (RA) lead exhibited high capture threshold. The lead was explanted and replaced. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877774 ↗
• MalfunctionSep 17, 2026Failure to Sense

  It was reported that the patient presented remotely via Merlin.net. Upon review of the remote transmission, consecutive premature ventricular contractions (PVCs) were noted on Merlin.net. Additionally, the atrial lead demonstrated undersensing, with atrial undersensing and loss of sensing observed on the electrograms (EGMs). No intervention was performed in response to the reported event. The patient's status was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50799074 ↗
• InjurySep 15, 2026Over-Sensing

  It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed that the patient's Right Ventricular (RV) lead and Right Atrial (RA) lead exhibited oversensing noise. Provocative maneuvers were performed; however, the noise could not be reproduced. The physician elected to explant both leads and replace them with new ones. The patient's condition remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775564 ↗
• InjurySep 9, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented to the hospital for a lead revision procedure. The right ventricular (RV) lead exhibited oversensed noise, resulting in pacing inhibition. Additionally, the right atrial (RA) lead exhibited oversensed noise, resulting in inappropriate automatic mode switch (AMS) episodes. Both the RV and RA leads were explanted and replaced. The patient was discharged with no reported adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684756 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with bacteremia, suspected to have originated either from a foot infection or a urinary tract infection (UTI). On (b)(6)2026, the physician elected to explant the entire pacing system, including the pacemaker, right atrial (RA) lead, and right ventricular (RV) lead. The patient remained in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50602849 ↗
• MalfunctionSep 4, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600907 ↗
• InjurySep 3, 2026Over-Sensing; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596755 ↗
• InjurySep 1, 2026Over-Sensing

  It was reported that the patient presented for a generator change procedure. Upon interrogation, right ventricle lead exhibited noise that was oversensed by the device and led to pacing inhibition. 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 50544925 ↗
• InjuryAug 26, 2026Capturing Problem

  It was reported that the patient presented in clinic for a generator exchange procedure. High capture thresholds were noted on the right atrial (RA) lead following an unrelated procedure the patient had prior. The patient was asymptomatic. The physician elected to replace the RA lead during the procedure. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50464502 ↗
• MalfunctionAug 24, 2026Over-Sensing

  It was noted that the right atrial (RA) lead exhibited noise oversensing led to pacing inhibition. The physician noted that the right ventricular (RV) lead had a known history of noise. To minimize oversensing, the RA sensitivity setting was adjusted, and the RV lead was programmed off, with the device switched to AAI mode. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50399738 ↗
• InjuryAug 24, 2026High impedance

  It was reported that the patient presented for follow up in clinic. It was noted that right atrial lead exhibited high pacing impedance. The lead was explanted and replaced. The patient was recovering in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50399044 ↗
• InjuryAug 21, 2026Failure to Capture; Fracture; High impedance

  It was reported that a patient presented with high capture thresholds, high pacing impedance, and fracture noted on the patient's right ventricular lead. Imaging was used to confirm. The lead was explanted and replaced on (b)(6) 2026. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50382820 ↗
• MalfunctionAug 21, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed high ventricular rate (HVR) episodes due to noise on the right ventricular (RV) lead and noise over-sensing resulting inappropriate automated mode switch (AMS) episodes on the right atrial (RA) lead. Programming changes were recommended. No patient symptoms or intervention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50361937 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with infection and endocarditis at device pocket. The gallant, right atrial (RA) lead and right ventricular (RV) lead were explanted. The infection was not associated with Abbott procedure/product. There was no erosion noted on the device and leads, and no vegetation noted on the leads. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50269217 ↗
• MalfunctionAug 14, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50247969 ↗
• MalfunctionAug 13, 2026Over-Sensing; Pacing Problem; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242440 ↗
• InjuryAug 13, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented for a scheduled procedure. It was noted that noise was observed on the right atrial lead causing inappropriate mode switch and RV pacing causing a decrease in the patients Ejection Fraction. The leads were capped and the device was replaced and a new system was implanted on the left side on 22 Jul 2026. There were no patient issues.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50230668 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was presented to the hospital with infection. The pacemaker, right ventricular (RV) and right atrial (RA) leads were explanted. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50151606 ↗
• InjuryAug 5, 2026Break; Low impedance

  It was reported that the patient presented for generator changeout procedure. Prior to the procedure, it was noted that the patient's right atrial lead exhibited low pacing impedance, reflective of insulation break. The physician opted to replace only the generator. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137306 ↗
• MalfunctionJul 27, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50004168 ↗
• InjuryJul 1, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THROUGH A REMOTE TRANSMISSION THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD 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 25674707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140033. One submission often covers many models, so check the product and lot details in each record.

• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1531-2021 · Mar 15, 2021 · Open, Classified
  ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycar
• Z-1530-2021 · Mar 15, 2021 · Open, Classified
  ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.