Durata™ 7170-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 05414734502436), received between Jun 11, 2018 and Sep 29, 2026 — classified as 60 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (49 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 117 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fracture; High impedance

  It was reported that Right Ventricular (RV) lead fractured and high pacing lead impedance was noted. The lead was capped on (b)(6) 2026. No patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933349 ↗
• InjuryNov 4, 2025Fracture; High impedance; Over-Sensing; Fracture; High impedance; Over-Sensing

  DURING AN IN-CLINIC FOLLOW-UP, NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. LEAD CONDUCTOR FRACTURE WAS SUSPECTED BUT IT WAS NOT CONFIRMED. A REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468666 ↗
• MalfunctionApr 10, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THE PATIENT REPORTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) ALERTS OCCURRED DUE TO THE RIGHT VENTRICULAR LEAD OVERSENSING NOISE. NO CHANGES OR INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084962 ↗
• InjuryMar 12, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD FAILED TO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887473 ↗
• MalfunctionMar 7, 2024Failure to Convert Rhythm; Low impedance; Failure to Convert Rhythm; Low impedance

  IT WAS REPORTED THAT THE PATIENT HAD VENTRICULAR TACHYCARDIA (VT). THE DEVICE FAILED TO DELIVER HIGH VOLTAGE THERAPY DUE TO LOW DEFIBRILLATION IMPEDANCE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. SUBSEQUENTLY, THE DEVICE APPROPRIATELY DETECTED THE VT AND SUCCESSFULLY DELIVERED HIGH VOLTAGE THERAPY. DURING IN-CLINIC FOLLOW-UP, THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: Arrhythmia

  MAUDE report 18856569 ↗
• InjuryFeb 20, 2024Impedance Problem; Impedance Problem

  RELATED MANUFACTURER REPORT NUMBER: (B)(4). DURING AN IN CLINIC FOLLOW UP, IMPEDANCE OUTSIDE OF THE NORMAL RANGE WAS OBSERVED ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE RA AND RV LEADS WERE CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740005 ↗
• MalfunctionDec 7, 2023Peeled/Delaminated; Peeled/Delaminated

  DURING A ROUTINE DEVICE EXCHANGE PROCEDURE, THE INSULATION OF THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO HAVE UNSHEATHED AND PEELED AWAY FROM THE LEAD BODY. THE RV LEAD WAS REPAIRED DURING THE PROCEDURE TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288179 ↗
• MalfunctionOct 5, 2023Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING EPISODES DUE TO LOSS OF CAPTURE, HIGH CAPTURE THRESHOLD, AND HIGH PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTION WAS PERFORMED; THE DEVICE WILL CONTINUE TO BE MONITORED. THE PATIENT WAS ASYMPTOMATIC AND STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882812 ↗
• MalfunctionAug 25, 2023Over-Sensing; Over-Sensing

  DURING A REMOTE FOLLOW-UP, EPISODES OF NOISE RESULTING IN OVERSENSING WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627591 ↗
• InjuryAug 1, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED, THAT THE PATIENT EXPERIENCED AN EPISODE OF ASYSTOLE. THE SYSTEM WAS INTERROGATED, AND ALL PARAMETERS WERE NORMAL. THE EPISODE OF ASYSTOLE WAS CAUGHT ON ELECTROCARDIOGRAM. AND MULTIPLE EPISODES OF RIGHT VENTRICULAR OVERSENSING WERE DETECTED BY THE ALGORITHM ON THE RIGHT VENTRICULAR (RV) LEAD. PROGRAMMING CHANGES TO COUNTER THE OVERSENSING WERE MADE. DURING INTERROGATION, SOME MISSED BEATS WERE NOTED WITH VERY SHORT RUNS OF NOISE ON THE RV LEAD. THE PHYSICIAN THEREFORE, OPTED TO IMPLANT A SENSE/PACE LEAD. A NEW RV LEAD WAS IMPLANTED IN THE HIGH MID SEPTUM. AND THE TERMINAL PIN WAS PLACED IN THE SENSE/PACE PORT OF THE EXISTING GENERATOR. THE EXISTING RV LEAD WAS LEFT IN PLACE, BUT THE SENSE/PACE TERMINAL WAS CAPPED (B)(6) 2023. A DEFIBRILLATION TEST WAS COMPLETED SUCCESSFULLY. THE PATIENT SPENT THE NIGHT PER PROTOCOL AT THE HOSPITAL. THE DEVICE WAS EVALUATED THE FOLLOWING MORNING AND ALL TESTS WERE GOOD. THE PATIENT WAS STABLE IMMEDIATELY AFTER PROCEDURE, THE FOLLOWING MORNING. AND WAS DISCHARGED THE DAY AFTER THE PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 17438693 ↗
• InjuryJun 2, 2023Signal Artifact/Noise; Break; Failure to Convert Rhythm; Signal Artifact/Noise; Break; Failure to Convert Rhythm

  IT WAS REPORTED THAT INADEQUATE HIGH VOLTAGE THERAPY WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, NOISE WAS NOTED ON THE RV LEAD. INSULATION DAMAGE OF THE RV LEAD WAS VISUALLY OBSERVED. THE SENSING AND PACING OF THE RV LEAD WAS DEACTIVATED AND AN ADDITIONAL LEAD WAS IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 17055975 ↗
• InjuryMay 24, 2023Break; Over-Sensing; Break; Over-Sensing

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, NOISE RESULTING IN OVERSENSING AND PACING INHIBITION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN SUSPECTED RV LEAD DAMAGE, HOWEVER, NO ANOMALIES WERE VISUALLY OBSERVED. THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16996346 ↗
• MalfunctionMay 1, 2023Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN IN-CLINIC FOLLOW-UP, EPISODES OF NOISE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE NOISE COULD BE REPRODUCED DURING PROVOCATIVE TESTING. NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846363 ↗
• MalfunctionMar 27, 2023Capturing Problem; Device Sensing Problem; Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THAT THE RIGHT VENTRICULAR (RV) LEAD HAD UNACCEPTABLE SENSING OF R-WAVES; MULTIPLE POSITIONS WERE ATTEMPTED. THE RV LEAD WAS NOT USED AND THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITH A DIFFERENT RV LEAD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618703 ↗
• MalfunctionMar 9, 2023Break; Over-Sensing; Break; Over-Sensing

  DURING FOLLOW-UP, OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. LEAD DAMAGE WAS SUSPECTED BUT WAS NOT CONFIRMED VISUALLY. THE RV LEAD WAS CAPPED AND REPLACED 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 16519195 ↗
• InjuryJan 25, 2023Break; High impedance; Break; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED THAT LEAD DAMAGE WAS SUSPECTED. THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244398 ↗
• MalfunctionDec 7, 2022High impedance; High impedance

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC DUE TO AN ALARM FROM THE DEVICE. UPON INTERROGATION, HIGH PACING IMPEDANCE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED PROVOCATIVE TESTING. PROVOCATIVE TESTING WAS PERFORMED AND NO ANOMALIES WERE NOTED. NO FURTHER INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934728 ↗
• MalfunctionDec 5, 2022High impedance; High impedance

  IT WAS REPORTED THAT HIGH PACING IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. ABBOTT TECHNICAL SUPPORT CONFIRMED THE EVENT AND AN X-RAY WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. NO ADDITIONAL INTERVENTION WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915789 ↗
• InjuryAug 26, 2022Break; Over-Sensing; Low impedance; Break; Over-Sensing; Low impedance

  DURING REMOTE FOLLOW-UP, NOISE RESULTING IN OVERSENSING AND LOW PACING IMPEDANCE DUE TO ALLEGED, BUT NOT CONFIRMED LEAD DAMAGE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. ISOMETRIC TESTING WAS PERFORMED AND NOISE WAS NOT REPRODUCED. NO INTERVENTION WAS PERFORMED AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299877 ↗
• InjuryAug 24, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-21328. IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC AFTER EXPERIENCING PALPITATION. UPON INTERROGATION, IT WAS FOUND THAT PATIENT'S ATRIAL AND RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. IT WAS FURTHER NOTED FROM FLUOROSCOPY THAT BOTH LEADS WERE DISLODGED. BOTH LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 15284434 ↗
• MalfunctionAug 9, 2022Break; Over-Sensing; Break; Over-Sensing

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-17156. IT WAS REPORTED THAT NOISE, OVERSENSING AND SUSPECTED LEAD DAMAGE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD AND MYOPOTENTIAL OVERSENSING WAS OBSERVED ON THE DEVICE. NO INTERVENTION HAS BEEN PERFORMED TO RESOLVE THE EVENT 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 15192827 ↗
• InjuryJul 18, 2022Capturing Problem; Device Sensing Problem; Capturing Problem; Device Sensing Problem

  DURING FOLLOW-UP, HIGH THRESHOLD AND DECREASED SENSING WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15043374 ↗
• MalfunctionJul 6, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED SENSING NOISE. NO INTERVENTION WAS PERFORMED. THE PHYSICIAN STATED THAT THEY WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940356 ↗
• InjuryJun 27, 2022Break; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Break; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT HIGH PACING IMPEDANCE, NOISE LEADING TO OVERSENSING, AND DELIVERY OF INAPPROPRIATE HIGH VOLTAGE THERAPY WERE OBSERVED ON THE RIGHT VENTRICULAR (RV). NOISE COULD BE REPRODUCED WITH PROVOCATIVE TESTING AND LEAD DAMAGE NEAR THE DEVICE HEADER WAS THE SUSPECTED CAUSE OF THE EVENT. THE LEAD WAS DEACTIVATED. THE LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14835851 ↗
• InjuryJun 2, 2022Break; Over-Sensing; Break; Over-Sensing

  DURING AN IN-CLINIC FOLLOW-UP, EPISODES OF OVERSENSING WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND SUSPECTED RV LEAD DAMAGE. LEAD REVISION IS ANTICIPATED TO RESOLVE THE EVENT, HOWEVER, NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14573568 ↗

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