Durata™ 7122Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,773 adverse event reports that list this exact device (DI 05414734503341), received between Jun 10, 2018 and Sep 30, 2026 — classified as 86 deaths, 3,173 injuries, 1,514 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (1,089 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 4,773 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954556 ↗
• MalfunctionSep 30, 2026Retraction Problem; Capturing Problem

  It was reported during implant procedure that the right ventricular lead displayed high capture thresholds. Upon repositioning, the helix could not be retracted. The lead was exchanged. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950422 ↗
• InjurySep 29, 2026Retraction Problem; Stretched; Capturing Problem

  It was reported that the patient presented in clinic for routine follow-up. An interrogation found that their Right Ventricular (RV) and Left Ventricular (LV) leads exhibited high capture thresholds. During revision procedure, it was noted that the RV lead helix failed to retract and ended up becoming stretched. The RV lead was explanted and replaced. While attempting to implant the replacement LV lead, it was noted that the patient had stenosis, resulting in the replacement lead failing to advance. The attempted replacement LV lead was not implanted, and another lead was implanted successfully on (b)(6) 2026. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936456 ↗
• MalfunctionSep 29, 2026Break

  It was reported that the patient presented for a scheduled implant procedure. During the procedure, it was noted that the helix of the right ventricular (RV) lead became distorted. The RV lead was not implanted, and an alternate lead was implanted instead on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936148 ↗
• MalfunctionSep 28, 2026Break; Difficult to Insert; Difficult to Remove

  It was reported that the patient presented for an implant procedure. While attempting to implant the lead, it was noted that it was difficult to insert. The physician attempted to remove the lead from the catheter and noted it was difficult to remove. After removing the lead from the catheter, the lead coil was noted to be damaged. The lead was not used and was replaced. The patient experienced no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924000 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with an infection and skin erosion at the device pocket site. The infection was not associated with any Abbott product and/or procedure. No erosion or lead vegetation was reported. The gallant and right ventricular lead were explanted. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50911034 ↗
• MalfunctionSep 28, 2026High impedance

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed that the right ventricular lead exhibited high defib lead impedance. Further information was requested, however, was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910860 ↗
• MalfunctionSep 26, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906462 ↗
• InjurySep 25, 2026Under-Sensing

  During an in-clinic follow-up, undersensing was observed on the right ventricular (RV) lead. An x-ray was performed and no anomalies were observed. The suspected cause was patient anatomy. The lead was explanted and replaced. The patient is stable and will continue to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903029 ↗
• InjurySep 25, 2026Failure to Capture; Over-Sensing; Failure to Sense; Device Dislodged or Dislocated

  During a follow-up in clinic, loss of sensing, loss of capture, and noise resulting in oversensing were observed on the right ventricular (RV) lead. Diagnostic imaging was performed, and the RV lead was found to be dislodged. A helix malfunction was the suspected cause of the dislodgment. The lead was explanted and replaced to resolve the event. The patient is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899003 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a clinical follow up. It was noted that the patient had experienced persistent redness and swelling at the cervical pocket site, along with symptoms of a pocket infection, for the past six months. The entire system, including the Implantable Cardioverter Defibrillator (ICD), right ventricular lead, right atrial lead, and left ventricular lead, was explanted. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50893645 ↗
• MalfunctionSep 24, 2026Over-Sensing

  During a remote follow-up, episodes of noise resulting in oversensing and myopotential oversensing were observed on the right ventricular (RV) lead. Technical Support was contacted and provided reprogramming recommendations. No intervention has been performed at this time. The patient was stable with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884205 ↗
• InjurySep 24, 2026Failure to Advance; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  During an in-clinic follow-up, a decrease in sensing and increase in capture threshold were observed on the right ventricular (RV) lead. Diagnostic imaging was performed and revealed the RV lead was dislodged. A revision procedure was performed. While attempting to reposition the RV lead, it was not possible to advance a stylet down the lead. The RV lead was explanted and replaced to resolve the event. The patient is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884079 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was implanted with implantable cardioverter defibrillator (ICD) on (b)(6) 2026. Post-operatively, the patient experienced recurrent fever. Subsequent echocardiography and ultrasound revealed vegetation on the atrial lead. A causal relationship between the reported infection and the procedure or the Abbott device could not be determined. Despite prolonged antibiotic therapy, the patient's condition did not improve. As a result, the ICD, atrial lead and right ventricle (RV) lead were explanted on (b)(6) 2026. Blood culture was taken however, the result was not reported. The patient had no consequences throughout the procedure. The cause of infection was related to vegetation on atrial lead.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50877066 ↗
• InjurySep 23, 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 infection was not associated with any Abbott product and/or procedure. The endocarditis was confirmed via diagnostic imaging. The whole system was explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50864479 ↗
• MalfunctionSep 19, 2026Difficult to Fold, Unfold or Collapse; High impedance; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50833655 ↗
• MalfunctionSep 19, 2026Difficult to Fold, Unfold or Collapse; Capturing Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50833654 ↗
• MalfunctionSep 18, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831573 ↗
• InjurySep 18, 2026High impedance; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831565 ↗
• MalfunctionSep 18, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829692 ↗
• InjurySep 18, 2026Capturing Problem; Device Dislodged or Dislocated

  It was reported that Right Ventricular (RV) lead dislodged due to Twiddling. High threshold was also noted. The lead was capped and replaced on (b)(6) 2026. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818600 ↗
• InjurySep 18, 2026High impedance; Capturing Problem

  It was reported that Right Ventricular (RV) lead exhibited high threshold and impedance. The lead was explanted and replaced. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818531 ↗
• InjurySep 18, 2026Failure to Capture; Therapy Delivered to Incorrect Body Area; Device Sensing Problem; Device Dislodged or Dislocated; Impedance Problem

  It was reported that the patient presented at the emergency room with complaints of diaphragmatic stimulation. Remote transmission noted high voltage impedance changes, decreased sensing, no capture on the right ventricular (RV) lead. Dislodgement was confirmed on the RV lead. Programming changes were made to turn OFF tachy therapy and pacing. The RV lead was explanted and replaced. The patient was stable throughout.

  Patient problems: Discomfort

  MAUDE report 50818344 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient presented with an infection and discomfort noted on the patient's implantable cardioverter defibrillator system. The system was explanted and replaced on (b)(6)2026. No adverse patient consequences were reported.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50813749 ↗
• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse; Failure to Advance

  It was reported that the patient presented for a new implant. It was noted that during the procedure, the guidewire could not be inserted into the right ventricular (RV) lead completely. When the physician attempted to adjust the RV lead, the helix could be retracted but could not be extended again. The RV lead was exchanged. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813164 ↗