Tendril MRIRecalls & reported problems across all models

We found 3 models of Tendril MRI by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 5,841 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 224 deaths, 3,479 injuries, 2,138 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (1,638 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Tendril MRI problems

Tendril MRI models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tendril MRI™ LPA1200M-52

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  111 deaths2,915 reports
• Tendril MRI™ LPA1200M-58

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  61 deaths1,801 reports
• Tendril MRI™ LPA1200M-46

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  52 deaths1,125 reports

Recent Tendril MRI adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjurySep 29, 2026Over-Sensing; Pacing Problem

  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 50927918 ↗
• MalfunctionSep 28, 2026Failure to Capture

  It was reported that the patient presented to clinic for a follow-up. It was noted that the right ventricular (RV) lead exhibited an elevated pacing threshold, resulting in ventricular non-capture with a subsequent delayed intrinsic ventricular conducted response. No changes or interventions were reported. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915686 ↗
• InjurySep 28, 2026Over-Sensing

  It was reported that the patient presented to clinic for a follow up. It was reported that the right ventricular (RV) lead exhibited oversensing noise resulting in pacing inhibition. 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 50910608 ↗
• MalfunctionSep 28, 2026Break; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910510 ↗
• MalfunctionSep 25, 2026Over-Sensing; Pacing Problem

  Patient problems: Insufficient Information

  MAUDE report 50892700 ↗
• InjurySep 24, 2026Signal Artifact/Noise

  It was reported that noise was observed on the right atrial (RA) lead. The RA lead was explanted and replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885676 ↗
• 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 ↗
• InjurySep 23, 2026Over-Sensing

  It was reported that the patient presented in the clinic for a follow-up. Upon interrogation, the right ventricular lead exhibited noise that was oversensed by the device and led to pacing inhibition. The lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863270 ↗
• MalfunctionSep 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809210 ↗
• 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 14, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented in clinic for a follow-up. Device interrogation indicated that the right atrial (RA) lead exhibited noise oversensing resulted 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 50749549 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
• Proclaim12 models · 35,038 reports · 17 recalls
• Durata28 models · 19,805 reports
• Assurity MRI2 models · 17,838 reports · 1 recall
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls