Durata™ 7122Q-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,202 adverse event reports that list this exact device (DI 05414734503174), received between Jun 11, 2018 and Sep 30, 2026 — classified as 151 deaths, 4,078 injuries, 1,973 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1,430 reports).

3 other recalls cover devices cleared under the same FDA submission (P950022); 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 6,202 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953445 ↗
• InjurySep 30, 2026Break; High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952994 ↗
• 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 50951651 ↗
• InjurySep 30, 2026Failure to Capture

  It was reported that the patient¿s right ventricular (RV) lead exhibited loss of capture. Chest X-ray confirmed cardiac perforation. The RV lead was explanted and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Cardiac Perforation

  MAUDE report 50941740 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a lead extraction was performed. Further information was requested however, was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941725 ↗
• InjurySep 30, 2026Failure to Capture

  It was reported that the patient received an inappropriate shock from the Implantable Cardioverter Defibrillator (ICD). Further evaluation revealed that the right ventricular (RV) lead exhibited loss of capture, and a Computed Tomography (CT) scan confirmed cardiac perforation. At the patient's request, the entire system, including the ICD, right ventricular (RV) lead, and right atrial (RA) lead, was explanted on (b)(6) 2026. The patient remained stable throughout the procedure.

  Patient problems: Cardiac Perforation

  MAUDE report 50941660 ↗
• InjurySep 29, 2026Device Dislodged or Dislocated

  It was reported that the patient's Right Ventricular (RV) lead was dislodged. The RV lead was explanted and replaced. The patient's condition was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938357 ↗
• InjurySep 28, 2026Device Dislodged or Dislocated

  It was reported that the right ventricular (RV) lead was dislodged. The RV lead was explanted and replaced to resolve event. The patient was stable with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919451 ↗
• InjurySep 24, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891948 ↗
• MalfunctionSep 24, 2026Signal Artifact/Noise

  It was reported that the right ventricular lead displayed noise. No intervention was reported and patient condition was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884692 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50831575 ↗
• InjurySep 18, 2026Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient experienced inappropriate shocks due to right ventricular (RV) lead noise and a sudden increase in pacing impedance, indicative of a lead fracture. The RV lead was capped and replaced on (b)(6) 2026. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818773 ↗
• InjurySep 18, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that Right Ventricular (RV) lead not capturing and not sensing appropriately. X ray showed lead had dislodged and lead tip was in SVC. It was suspected that dislodgement was completely due to Twiddlers syndrome. The lead was explanted and replaced. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818644 ↗
• InjurySep 18, 2026Failure to Capture

  It was reported during a follow-up in clinic it was noticed that the Right Ventricular (RV) lead was not capturing. 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 50818483 ↗
• InjurySep 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812528 ↗
• InjurySep 16, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50796952 ↗
• MalfunctionSep 16, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796471 ↗
• MalfunctionSep 16, 2026Over-Sensing; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794195 ↗
• InjurySep 16, 2026High impedance; Capturing Problem

  During a follow up in person, increased pacing impedance and increased capture threshold were observed on the right ventricular (RV) lead. The lead was capped and a new lead was implanted to resolve the event. The patient is stable and will continue to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790946 ↗
• MalfunctionSep 15, 2026Over-Sensing

  It was reported during remote follow up that the right ventricular lead displayed myopotential oversensing. The product will continue to be monitored. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779663 ↗
• 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 50775571 ↗
• InjurySep 15, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that Right Ventricular (RV) lead dislodged. The lead was not capturing or sensing appropriately. The lead was explanted and replaced. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773457 ↗
• InjurySep 14, 2026Difficult to Fold, Unfold or Collapse; Device Dislodged or Dislocated

  It was reported that the patient presented to the hospital after receiving a vibratory alert for high pacing impedance on the right atrial (RA) lead. Upon a chest X-ray, the RA lead was completely twisted back into the pocket, and the right ventricular (RV) lead was also found dislodged; however, it was still in the ventricle and functioning. Twiddler's syndrome was suspected. Upon attempting to reposition the RV lead, the helix would not extend. Both leads were explanted. The patient was asymptomatic and was stable before, during, and after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752703 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with sepsis, fever and redness and swelling at the device implant site due to infection. It was also noted that the patient's left ventricular (LV) lead had vegetation due to the infection which was noted via echocardiography. The physician stated that the infection was not related to Abbotts' devices. The patient's implantable cardioverter defibrillator, the LV lead, the right atrial lead and the right ventricular lead were explanted due to the infection. A new system was implanted. The patient was stable throughout.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50749359 ↗
• InjurySep 11, 2026Failure to Capture; Device Dislodged or Dislocated

  Patient problems: Discomfort

  MAUDE report 50742468 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950022. One submission often covers many models, so check the product and lot details in each record.

• Z-0660-2016 · Nov 3, 2015 · Terminated
  Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Car
• Z-0458-2012 · Nov 28, 2011 · Terminated
  St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous
• Z-0457-2012 · Nov 28, 2011 · Terminated
  St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads co