Durata™ 7121-65Recalls & reported problems
St. Jude Medical, Inc. · Defibrillation Lead · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Durata defibrillation lead has 427 reports, including 23 deaths and 231 injuries. Common problems described include the lead misreading heart signals, high electrical resistance, lead fractures, and failure to stimulate the heart, and some patients needed the lead removed and replaced. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 429
- Deaths reported
- 23
- Injuries reported
- 229
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 429 adverse event reports that list this exact device (DI 05414734502122), received between Jun 11, 2018 and Sep 16, 2026 — classified as 23 deaths, 229 injuries, 177 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (162 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.
Reports received per month
Most reported problems
Device problems
- Over-Sensing162
- High impedance121
- Signal Artifact/Noise90
- Adverse Event Without Identified Device or Use Problem45
- Fracture39
- Capturing Problem36
- Inappropriate/Inadequate Shock/Stimulation31
- Failure to Capture29
Patient problems
- No Clinical Signs, Symptoms or Conditions225
- No Known Impact Or Consequence To Patient112
- Unspecified Infection16
- No Consequences Or Impact To Patient15
- Death14
- Therapeutic Effects, Unexpected13
- No Information11
- Insufficient Information10
Recent adverse event reports
The 25 most recent of 429 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794288 ↗MalfunctionSep 10, 2026Over-Sensing; Capturing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721100 ↗MalfunctionSep 3, 2026High impedance
Patient problems: Insufficient Information
MAUDE report 50599630 ↗MalfunctionAug 25, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50438447 ↗MalfunctionAug 21, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50380476 ↗MalfunctionJul 30, 2026Failure to Capture; Over-Sensing
New information noted that the right ventricular lead exhibited loss of capture. The lead was explanted and replaced on (b)(6)2026. The patient was recovering.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50078447 ↗MalfunctionJun 18, 2026Over-Sensing; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. A REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THE PATIENT HAD NO CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25548486 ↗InjuryMay 18, 2026Failure to Capture; Fracture
IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO LEAD FRACTURE AND FAILURE TO CAPTURE. THE PATIENT IS RECOVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201569 ↗InjuryMay 14, 2026Failure to Capture; High impedance
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. A DEVICE INTERROGATION SHOWED THAT THEIR RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE CORRELATED WITH INCREASED CAPTURE THRESHOLD AND NONCAPTURE. 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 25176821 ↗MalfunctionApr 17, 2026Intermittent Capture
IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE. NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917607 ↗InjuryApr 17, 2026Failure to Capture; High impedance
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH PACING IMPEDANCE AND FAILURE TO CAPTURE. THE RV LEAD WAS CAPPED ON (B)(6) 2026 AND SUCCESSFULLY REPLACED. THE PATIENT WAS DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916132 ↗InjuryApr 11, 2026High impedance; Over-Sensing; Capturing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR RIGHT VENTRICULAR (RV) LEAD EXPLANT. DEVICE INTERROGATION REVEALED THAT THE RV LEAD EXHIBITED VARYING CAPTURE THRESHOLD, HIGH PACING IMPEDANCE, AND OVERSENSING NOISE. FLUOROSCOPY WAS PERFORMED, AND NO DEFECTS WERE OBSERVED. DURING THE PROCEDURE, INSULATION DAMAGE WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. BOTH LEADS WERE EXPLANTED AND REPLACED WITH NEW ONES. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849153 ↗InjuryApr 8, 2026High impedance; Capturing Problem
NEW INFORMATION RECEIVED NOTES THIS RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED HIGH CAPTURE THRESHOLDS PRIOR TO EXPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824507 ↗MalfunctionMar 30, 2026Over-Sensing
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED VIA MERLIN.NET. IT WAS NOTED THAT NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD ON A STORED VENTRICULAR FIBRILLATION (VF) EPISODE. NO INAPPROPRIATE THERAPY WAS DELIVERED, AS A RETURN TO SINUS WAS DETECTED DURING CAPACITOR CHARGING. THE PATIENT PRESENTED FOR ADDITIONAL TESTING IN CLINIC. THE NOISE WAS NOT REPRODUCIBLE IN CLINIC. PROGRAMMING CHANGES WERE COMPLETED. THE PATIENT WAS JUST BEING MONITORED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728398 ↗InjuryMar 20, 2026Fracture; Over-Sensing
IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026 DUE FRACTURE. LEAD FRACTURE WAS CONFIRMED BY NOISE AND THE NOISE WAS OVER-SENSED. THE PATIENT IS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24652929 ↗InjuryMar 17, 2026Over-Sensing
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. ALL OTHER ELECTRICAL VALUES WERE NORMAL. THE RV LEAD WAS CAPPED (B)(6) 2026 AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618937 ↗InjuryMar 11, 2026Signal Artifact/Noise; Impedance Problem
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED NOISE AND VARYING IMPEDANCE. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572336 ↗InjuryFeb 27, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE RV LEAD WAS SURGICALLY REPAIRED DUE TO UNSPECIFIED REASON. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24476696 ↗InjuryFeb 5, 2026Fracture; High impedance; Over-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING NOISE DUE TO A SUSPECTED LEAD FRACTURE. IT WAS NOTED THAT HIGH VOLTAGE LEAD IMPEDANCE HAD AN ABRUPT INCREASE AS WELL AND TACHY THERAPIES WERE TURNED OFF PRIOR TO LEAD REPLACEMENT. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269198 ↗InjuryFeb 4, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. A DEVICE INTERROGATION WAS PERFORMED AND REVEALED THAT THEIR RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259367 ↗MalfunctionFeb 2, 2026High impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS REPORTED, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24241946 ↗MalfunctionJan 7, 2026Over-Sensing
IT WAS REPORTED THAT MYOPOTENTIALS OVERSENSING WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995796 ↗InjuryDec 30, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED A NOISE PROBLEM. NO INTERVENTION WAS REPORTED. PATIENT STATUS WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23928041 ↗MalfunctionDec 23, 2025Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT DURING A FOLLOW-UP CLINIC CHECK, NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE HEALTH CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878471 ↗MalfunctionDec 11, 2025High impedance; High impedance
IT WAS REPORTED THAT AN ALERT WAS OBSERVED NOTING THE HIGH VOLTAGE LEAD IMPEDANCE (HVLI) WAS HIGH ON THE RIGHT VENTRICULAR (RV) LEAD. UPON REVIEW, IT WAS NOTED THAT THE UPPER LIMIT FOR THE ALERT HAD BEEN SET TO 101 OHMS ON THIS PATIENT FOR UNKNOWN REASONS WHILE THE NORMAL UPPER LIMIT FOR (HVLI) IS 200 OHMS. THE LIMIT WAS TO BE DISCUSSED WITH THE PHYSICIAN. THE PATIENT WAS STABLE DURING CHECKUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23775099 ↗
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 · TerminatedOptisure 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 · TerminatedSt. 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 · TerminatedSt. 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
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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