Durata™ 7122 (UDI 05414734502153)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,377 adverse event reports that list this exact device (DI 05414734502153), received between Jun 11, 2018 and Sep 11, 2026 — classified as 27 deaths, 753 injuries, 597 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (492 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,377 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736628 ↗
• MalfunctionSep 10, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722615 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; High impedance; Under-Sensing; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721888 ↗
• MalfunctionAug 28, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50505853 ↗
• MalfunctionAug 26, 2026Over-Sensing

  It was reported that non sustained right ventricular oversensing (NSRVOS) was noted on stored electrocardiograms (EGMs) via remote transmissions. The NSRVOS was suspected to be due to noise on the right ventricular (RV) lead. The patient's wife noted the noise may have coincided with physical activity by the patient such as physiotherapy or getting up from a wheelchair. The noise was reproducible with isometric testing in clinic. Other RV lead parameters were stable. Programming changes were made. The patient was to continue being monitored. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50443866 ↗
• MalfunctionAug 25, 2026High impedance

  It was reported that the patient's right ventricular (RV) lead exhibited a high pacing impedance. Multiple reposition attempts were made during the procedure on (b)(6) 2026 to achieve optimal parameters, but the RV lead was ultimately explanted and replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438453 ↗
• MalfunctionAug 14, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260255 ↗
• MalfunctionAug 14, 2026Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50259146 ↗
• MalfunctionAug 10, 2026Signal Artifact/Noise

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50200546 ↗
• InjuryAug 5, 2026Failure to Capture; Device Sensing Problem

  It was reported that during remote follow-up, the patient's right ventricular (RV) lead exhibited a low R-wave amplitude. During in-clinic testing, loss of capture was also noted on the RV lead. X-ray and computed tomography (CT) imaging revealed that the RV lead had perforated the myocardium and pericardium, with the tip of the lead located in the left pericardial fat. The physician elected to explant the RV lead and replace it with a new one. Following the procedure, a pericardial effusion was observed, and the patient underwent a sternotomy with attempted repair. The patient condition remained stable.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50148127 ↗
• MalfunctionJul 29, 2026High impedance; Retraction Problem; Under-Sensing; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077350 ↗
• MalfunctionJul 13, 2026Over-Sensing

  IT WAS REPORTED THAT ONE EPISODE OF NON-SUSTAINED RIGHT VENTRICULAR (RV) OVERSENSING DETERMINED TO BE DUE TO NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS BEING MONITORED. THE PATIENT WAS STABLE; THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25802342 ↗
• MalfunctionJun 26, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE. PROGRAMMING CHANGES WERE PERFORMED TO DISABLE THERAPIES AND ADDRESS THE EVENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25639286 ↗
• MalfunctionJun 25, 2026High impedance

  IT WAS REPORTED DURING IMPLANT PROCEDURE THAT THE RIGHT VENTRICULAR LEAD AND LEFT VENTRICULAR LEADS DISPLAYED HIGH PACING IMPEDANCE. NEITHER WAS IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630185 ↗
• MalfunctionMay 28, 2026High impedance

  IT WAS REPORTED THAT HIGH DEFIBRILLATION IMPEDANCE WAS NOTED ON THE RIGHT VENTRICLE (RV) LEAD. ABBOTT TECHNICAL SUPPORT WAS CONTACTED; HOWEVER, NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317274 ↗
• MalfunctionMay 21, 2026Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN UPGRADE. DURING AN ATTEMPT TO PLACE THE RIGHT VENTRICULAR (RV) LEAD, THE STYLET WOULD NOT ADVANCE THROUGH THE RV LEAD, AND IT COULD NOT BE REMOVED. EVENTUALLY THE STYLET WAS PULLED OUT, BUT THE LEAD'S INSULATION CAME APART. THE PHYSICIAN SUSPECTED THE INSULATION HAD INITIALLY BEEN DAMAGED. THE RV LEAD WAS EXCHANGED DURING THE UPGRADE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247947 ↗
• MalfunctionMay 19, 2026Over-Sensing

  DURING A FOLLOW-UP, EPISODES OF NOISE WHICH RESULTED IN OVERSENSING WERE NOTED ON THE RIGHT VENTRICULAR (RV) CHANNEL OF THE DEVICE. PROVOCATIVE TESTING WAS PERFORMED AND THE LEAD NOISE WAS REPRODUCED. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVED THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224361 ↗
• MalfunctionMay 14, 2026Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN WAS UNABLE TO COMPLETELY ADVANCE A STYLET WITHIN THE RIGHT VENTRICLE (RV) LEAD AND IT WAS DIFFICULT TO REMOVE STYLETS FROM THE RV LEAD. THE RV LEAD WAS NOT IMPLANTED AND WAS REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177552 ↗
• MalfunctionMay 8, 2026Failure to Capture; Retraction Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT. DURING THE PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. THE PHYSICIAN ATTEMPTED TO RETRACT THE RV LEAD HELIX, HOWEVER THE HELIX FAILED TO RETRACT COMPLETELY. THIS RV LEAD WAS NOT USED, AND THE PHYSICIAN COMPLETED THE PROCEDURE USING A DIFFERENT RV LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130924 ↗
• MalfunctionMay 7, 2026Break; Over-Sensing

  DURING AN IN-CLINIC FOLLOW-UP, NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. PROVOCATIVE TESTING WAS PERFORMED BUT THE NOISE WAS NOT REPRODUCED. LEAD DAMAGE WAS SUSPECTED BUT NOT CONFIRMED. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112242 ↗
• MalfunctionMay 1, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE HELIX OF THE RIGHT VENTRICULAR (RV) LEAD DID NOT EXTEND IN GRADUAL INCREMENTS DURING THE IMPLANT PROCEDURE. THE RV LEAD WAS REMOVED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059948 ↗
• MalfunctionApr 17, 2026Low impedance; Capturing Problem

  IT WAS REPORTED THAT THERE AS A DECREASE IN DEFIBRILLATION IMPEDANCE AND VARYING THRESHOLD THAT WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SUPPORT WAS CONTACTED AND GAVE REPROGRAMMING RECOMMENDATIONS. NO INTERVENTION HAS BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915687 ↗
• MalfunctionApr 14, 2026Failure to Capture; Fracture; High impedance

  DURING A CLINIC FOLLOW-UP, AN INCREASE IN THE PACING IMPEDANCE AND A LOSS OF CAPTURE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD ON A NON-PACEMAKER DEPENDENT PATIENT. AN RV LEAD FRACTURE WAS ALLEGED, BUT WAS UNABLE TO BE CONFIRMED. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876775 ↗
• InjuryApr 14, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. A DEVICE INTERROGATION SHOWED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING WHICH RESULTED IN PACING INHIBITION. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876010 ↗
• MalfunctionApr 13, 2026Over-Sensing

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED OVERSENSING NOISE. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853762 ↗

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-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
• 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