Durata™ 7120Q-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,092 adverse event reports that list this exact device (DI 05414734502818), received between Jun 11, 2018 and Sep 30, 2026 — classified as 59 deaths, 1,286 injuries, 747 malfunctions.

The most frequently reported specific device problem is “High impedance” (566 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,092 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that the patient presented in clinic for a routine generator change. During procedure, it was discovered that the patient's Right Ventricular (RV) lead exhibited an outer insulation abrasion. Medical adhesive and a suture sleeve were used to cover the abrasion. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949198 ↗
• InjurySep 24, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient received inappropriate Anti-Tachycardia Pacing (ATP) due to sensing noise from the right ventricular (RV) lead. No intervention was made at this time. The patient was stable.

  Patient problems: Insufficient Information

  MAUDE report 50890297 ↗
• InjurySep 15, 2026Signal Artifact/Noise; High impedance; Capturing Problem

  It was reported that the patient presented due to a high pacing impedance, high capture threshold, and noise noted on their right ventricular (RV) lead. The RV lead was explanted and successfully replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766367 ↗
• InjurySep 9, 2026Failure to Capture; Difficult to Fold, Unfold or Collapse; Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702603 ↗
• MalfunctionSep 8, 2026High impedance

  Patient problems: Insufficient Information

  MAUDE report 50677579 ↗
• InjuryAug 31, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed that the patient's right ventricular (RV) lead delivered an inappropriate shock due to noise oversensing. Isometric testing was performed during an in-clinic follow-up, and the lead noise was able to be reproduced. Programming changes were made. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533257 ↗
• InjuryAug 28, 2026Over-Sensing

  It was reported that Right Ventricular (RV) lead exhibited noise on the ventricular channel. The noise was over-sensed resulting in pacing inhibition. 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 50498306 ↗
• DeathAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient deceased. There is no known allegation from a health professional that suggests the death was related to the device. It was reported that the cause of death was unknown.

  Patient problems: Insufficient Information

  MAUDE report 50487919 ↗
• InjuryAug 27, 2026Over-Sensing

  It was reported that the patient was asymptomatic and not dependent on the device for normal function. It was noted that noise with oversensing was observed on the right ventricular (RV) lead. No other anomalies were observed. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484019 ↗
• MalfunctionAug 17, 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 pacing impedance. No intervention was performed. The physician elected to continue to monitor.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287248 ↗
• InjuryAug 7, 2026High impedance

  It was reported that the right ventricular (RV) exhibited a high high-voltage impedance. The RV lead was capped and replaced on (b)(6) 2026. The patient was stable before, during, and after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184128 ↗
• MalfunctionJun 26, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE DEFIBRILLATION IMPEDANCE. PROGRAMMING CHANGES WERE DISCUSSED, NO INTERVENTION WAS REPORTED, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641098 ↗
• MalfunctionJun 24, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING. PROGRAMMING CHANGES WERE MADE; HOWEVER, NOISE OVERSENSING RECURRED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611705 ↗
• InjuryJun 23, 2026High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026 WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25594735 ↗
• MalfunctionJun 16, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. A REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING. IT WAS ALSO NOTED THAT THE PATIENT'S ICD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524112 ↗
• InjuryJun 12, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DEVICE CHECK IN CLINIC, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING. X-RAY SHOWED THAT THE LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486597 ↗
• MalfunctionJun 10, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR FOLLOW UP. DURING DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EXTERNAL NOISE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465121 ↗
• InjuryJun 9, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DISPLAYED A NOISE PROBLEM. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. PATIENT CONDITION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451858 ↗
• DeathJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DEPENDENT ON THE DEVICE FOR NORMAL FUNCTION. IT WAS REPORTED THAT THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA (VT) IN THE MONITOR ZONE. THE VT PROGRESSED TO SLOW VENTRICULAR FIBRILLATION (VF) AND DEGENERATED INTO A FINE VF. THE UNDER SENSING OF THE FINE VF POTENTIALLY LED TO A LACK OF DEFIBRILLATION THERAPY DELIVERED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WAS SUBSEQUENTLY FOUND TO HAVE PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 25429620 ↗
• InjuryJun 3, 2026Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. A DEVICE INTERROGATION WAS PERFORMED AND REVEALED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING AND HIGH, OUT-OF-RANGE PACING IMPEDANCE. IT WAS SUSPECTED THAT THE RV LEAD WAS FRACTURED. THE RV LEAD WAS CAPPED AND REPLACED ON 18 MAY 2026. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25377057 ↗
• InjuryMay 19, 2026Signal Artifact/Noise

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225143 ↗
• InjuryMay 19, 2026Capturing Problem

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. IT WAS DECIDED TO IMPLANT A DUAL AVEIR DEVICE AS THE PATIENT DID NOT NEED THE ICD. THE THERAPIES ON THE DEVICE WERE TURNED OFF. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217019 ↗
• MalfunctionMay 8, 2026Break; Over-Sensing; Low impedance; Charging Problem

  DURING FOLLOW-UP, SENSING NOISE AND DECREASED DEFIBRILLATION IMPEDANCE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128403 ↗
• InjuryApr 28, 2026Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT A GRADUAL YET FAIRLY SPONTANEOUS RISE IN PACING IMPEDANCE AND LOSS OF CAPTURE AND A HIGH CAPTURE THRESHOLD WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. A FRACTURE WAS SUSPECTED ON THE RV LEAD. THE RV LEAD WAS CAPPED (B)(6) 2026 AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023678 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND LOW OUT-OF-RANGE PACING IMPEDANCE. ON (B)(6) 2026, DURING THE LEAD REVISION PROCEDURE, FLUOROSCOPY WAS PERFORMED NOTING INSULATION DAMAGE ON THE RA AND RIGHT VENTRICULAR (RV) LEADS. THE PHYSICIAN CAPPED AND REPLACED THE RA AND RV LEADS THAT SAME DAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009548 ↗

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