Durata® 7131-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734505123), received between Aug 5, 2018 and Mar 22, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING NOISE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595610 ↗
• InjuryJan 17, 2023Over-Sensing; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-01215. IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON EXAMINATION, IT WAS NOTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO HAVE EXHIBITED AN UNSPECIFIED OUTPUT ISSUE, AND THE PATIENT'S RIGHT VENTRICULAR LEAD WAS FOUND TO HAVE OVER-SENSING OF NOISE. CORRECTIVE PROGRAMMING CHANGES WERE MADE, AND FURTHER SURGICAL INTERVENTION WAS PLANNED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 16180336 ↗
• MalfunctionNov 9, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED POST-PACED T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTION WAS PERFORMED; THE DEVICE WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762806 ↗
• InjuryJun 9, 2021High impedance; High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON INTERROGATION, THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2021. THE PATIENT DID NOT SUFFER ANY ADVERSE CONSEQUENCES THROUGHOUT THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967735 ↗
• InjuryJul 10, 2020Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-08953. IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UNRELATED TO THE DEVICES ON (B)(6) 2020. TOWARDS THE END OF THE PROCEDURE, PATIENT'S RIGHT VENTRICULAR LEAD EXHIBITED CROSSTALK OVER-SENSING AND FAILED TO CAPTURE. PHYSICIAN ATTEMPTED TO REPROGRAM THE DEVICE. PATIENT THEN WENT ASYSTOLE. DEVICE WAS REPROGRAMMED AGAIN AND CAPTURE RESUMED. FURTHER INVESTIGATION FOUND THAT PATIENT'S RIGHT ATRIAL LEAD MAY HAVE ALSO BEEN OVER-SENSING AND INHIBITING PACING. BOTH LEADS WERE CAPPED AND REPLACED ON (B)(6) 2020. PATIENT CONDITION AFTER THE PROCEDURE WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 10258764 ↗
• MalfunctionAug 5, 2018Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR SURGERY DUE TO A ROUTINE GENERATOR CHANGE. IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND UNACCEPTABLE THRESHOLDS. THE LEAD WAS CAPPED 07/10/2018 AND REPLACED. THE PATIENT WAS STABLE BEFORE AND AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7749790 ↗

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