DurataRecalls & reported problems across all models
St. Jude Medical, Inc. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19,805
- Deaths reported
- 526
- Injuries reported
- 12,452
- Recalls
- 0
We found 28 models of Durata by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 19,805 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2018 and Sep 30, 2026 — classified as 526 deaths, 12,452 injuries, 6,827 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (5,173 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Durata problems
Device problems
- Over-Sensing5,173
- High impedance4,252
- Device Dislodged or Dislocated3,094
- Adverse Event Without Identified Device or Use Problem2,732
- Failure to Capture2,690
- Signal Artifact/Noise2,486
- Capturing Problem2,266
- Break1,684
Patient problems
- No Clinical Signs, Symptoms or Conditions9,891
- No Known Impact Or Consequence To Patient4,548
- Unspecified Infection1,885
- Discomfort647
- No Consequences Or Impact To Patient573
- Therapeutic Effects, Unexpected560
- Cardiac Perforation517
- Shock from Patient Lead(s)389
Durata models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Durata™ 7122Q-58Permanent defibrillator electrodes151 deaths6,202 reports
- Durata™ 7122Q-65Permanent defibrillator electrodes86 deaths4,773 reports
- Durata™ 7120Q-58Permanent defibrillator electrodes59 deaths2,092 reports
- Durata™ 7122Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
- Durata™ 7120Q-65Permanent defibrillator electrodes32 deaths1,140 reports
- Durata™ 7120Implantable cardioverter defibrillator (non-CRT)31 deaths857 reports
- Durata™ 7121Q-58Permanent defibrillator electrodes27 deaths529 reports
- Durata™ 7122Q-52Permanent defibrillator electrodes13 deaths510 reports
- Durata™ 7121Q-65Permanent defibrillator electrodes21 deaths478 reports
- Durata™ 7121-65Implantable cardioverter defibrillator (non-CRT)23 deaths429 reports
- Durata™ 7120Implantable cardioverter defibrillator (non-CRT)25 deaths345 reports
- Durata™ 7120Q-52Permanent defibrillator electrodes11 deaths289 reports
- Durata™ 7122Implantable cardioverter defibrillator (non-CRT)7 deaths168 reports
- Durata™ 7170Q-58Permanent defibrillator electrodes3 deaths166 reports
- Durata™ 7170-65Implantable cardioverter defibrillator (non-CRT)117 reports
- Durata™ 7170Q-65Permanent defibrillator electrodes1 death97 reports
- Durata™ 7121-60Implantable cardioverter defibrillator (non-CRT)4 deaths72 reports
- Durata™ 7171Q-58Permanent defibrillator electrodes58 reports
- Durata™ 7171Q-65Permanent defibrillator electrodes4 deaths40 reports
- Durata™ 7121Q-52Permanent defibrillator electrodes35 reports
- Durata™ 7171-65Implantable cardioverter defibrillator (non-CRT)1 death12 reports
- Durata® 7131-65Implantable cardioverter defibrillator (non-CRT)6 reports
- Durata™ 7121/75Implantable cardioverter defibrillator (non-CRT)4 reports
- Durata® 7130-60Implantable cardioverter defibrillator (non-CRT)4 reports
- Durata™ 7170Q-52Permanent defibrillator electrodes2 reports
- Durata™ 7120/75Implantable cardioverter defibrillator (non-CRT)1 report
- Durata™ 7122/75Implantable cardioverter defibrillator (non-CRT)1 report
- Durata™ 7171Q-52Permanent defibrillator electrodes1 report
Recent Durata adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954556 ↗MalfunctionSep 30, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953445 ↗InjurySep 30, 2026Break; High impedance; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952994 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had bacteremia and their Implantable Cardioverter Defibrillator (ICD), right ventricular (RV) lead, right atrial (RA) lead, and left ventricular (LV) lead were explanted as a result. The patient was stable.
Patient problems: Unspecified Infection
MAUDE report 50951651 ↗MalfunctionSep 30, 2026Retraction Problem; Capturing Problem
It was reported during implant procedure that the right ventricular lead displayed high capture thresholds. Upon repositioning, the helix could not be retracted. The lead was exchanged. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950422 ↗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 30, 2026Failure to Capture
It was reported that the patient¿s right ventricular (RV) lead exhibited loss of capture. Chest X-ray confirmed cardiac perforation. The RV lead was explanted and replaced on (b)(6) 2026. The patient was in stable condition.
Patient problems: Cardiac Perforation
MAUDE report 50941740 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a lead extraction was performed. Further information was requested however, was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941725 ↗InjurySep 30, 2026Failure to Capture
It was reported that the patient received an inappropriate shock from the Implantable Cardioverter Defibrillator (ICD). Further evaluation revealed that the right ventricular (RV) lead exhibited loss of capture, and a Computed Tomography (CT) scan confirmed cardiac perforation. At the patient's request, the entire system, including the ICD, right ventricular (RV) lead, and right atrial (RA) lead, was explanted on (b)(6) 2026. The patient remained stable throughout the procedure.
Patient problems: Cardiac Perforation
MAUDE report 50941660 ↗MalfunctionSep 29, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941184 ↗InjurySep 29, 2026Device Dislodged or Dislocated
It was reported that the patient's Right Ventricular (RV) lead was dislodged. The RV lead was explanted and replaced. The patient's condition was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938357 ↗MalfunctionSep 29, 2026Break; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936671 ↗InjurySep 29, 2026Retraction Problem; Stretched; Capturing Problem
It was reported that the patient presented in clinic for routine follow-up. An interrogation found that their Right Ventricular (RV) and Left Ventricular (LV) leads exhibited high capture thresholds. During revision procedure, it was noted that the RV lead helix failed to retract and ended up becoming stretched. The RV lead was explanted and replaced. While attempting to implant the replacement LV lead, it was noted that the patient had stenosis, resulting in the replacement lead failing to advance. The attempted replacement LV lead was not implanted, and another lead was implanted successfully on (b)(6) 2026. The patient was stable throughout.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936456 ↗MalfunctionSep 29, 2026Break
It was reported that the patient presented for a scheduled implant procedure. During the procedure, it was noted that the helix of the right ventricular (RV) lead became distorted. The RV lead was not implanted, and an alternate lead was implanted instead on (b)(6) 2026. The patient remained in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936148 ↗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 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
- Fortify Assura8 models · 8,292 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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