QuickflexRecalls & reported problems across all models
St. Jude Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,164
- Deaths reported
- 36
- Injuries reported
- 581
- Recalls
- 0
We found 3 models of Quickflex by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,164 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 24, 2026 — classified as 36 deaths, 581 injuries, 547 malfunctions.
The most frequently reported specific device problem is “Failure to Capture” (295 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 Quickflex problems
Device problems
- Failure to Capture295
- High impedance226
- Device Dislodged or Dislocated184
- Capturing Problem154
- Adverse Event Without Identified Device or Use Problem152
- High Capture Threshold107
- Break88
- Low impedance88
Patient problems
- No Clinical Signs, Symptoms or Conditions514
- No Known Impact Or Consequence To Patient343
- Unspecified Infection94
- Discomfort60
- No Consequences Or Impact To Patient47
- Death27
- Undesired Nerve Stimulation21
- Muscle Stimulation18
Quickflex models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quickflex™ 1258TDrug eluting permanent left ventricular (lv) pacemaker electrode26 deaths996 reports
- Quickflex™ 1258TDrug eluting permanent left ventricular (lv) pacemaker electrode7 deaths121 reports
- Quickflex™ 1258TDrug eluting permanent left ventricular (lv) pacemaker electrode3 deaths47 reports
Recent Quickflex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Failure to Capture
It was reported that the patient presented to hospital for an implant procedure. During the procedure, despite multiple repositioning attempts, it was noted that the left ventricular (LV) lead exhibited loss of capture. The LV lead was not used and was replaced on (b)(6) 2026. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879102 ↗MalfunctionSep 23, 2026Separation Failure; Device Dislodged or Dislocated
It was reported that the patient presented to the hospital for a scheduled implant procedure. During the procedure, the guidewire could not be separated from the left ventricular (LV) lead, resulting in lead dislodgement. Fluoroscopy confirmed the lead dislodgement. The physician attempted to use a different guidewire; however, this was unsuccessful. The LV lead was removed and replaced. The patient remained in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864824 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the hospital with infection and endocarditis at device pocket. The infection was not associated with any Abbott product and/or procedure. The endocarditis was confirmed via diagnostic imaging. The whole system was explanted and replaced. The patient was in stable condition throughout the procedure.
Patient problems: Unspecified Infection
MAUDE report 50864474 ↗MalfunctionSep 16, 2026High impedance
It was reported that the patient presented for an implant procedure. During the procedure, the left ventricle lead exhibited high pacing impedance. The lead was not used and replaced. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788928 ↗MalfunctionSep 2, 2026Failure to Capture; High impedance; Therapy Delivered to Incorrect Body Area; Low impedance
Patient problems: Discomfort
MAUDE report 50572861 ↗MalfunctionAug 28, 2026High impedance; Device Sensing Problem
It was reported that during an implant procedure, the left ventricle (LV) exhibited high pacing impedance and R-wave amplitude variation at several different locations. As a result, the LV lead was not used and it was replaced with a new lead. The patient had no consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50492308 ↗MalfunctionAug 27, 2026Failure to Capture; Therapy Delivered to Incorrect Body Area; Under-Sensing
It was reported that the patient presented for an implant procedure. During the procedure, it was noted that the left ventricular lead exhibited a low R-wave amplitude, resulting in under-sensing. The lead also exhibited a high capture threshold with phrenic nerve stimulation, resulting in patient discomfort. The high capture threshold subsequently resulted in loss of capture. The lead was not used, and the procedure was completed with a conventional Dual-Chamber Implantable Cardioverter Defibrillator (DICD) implantation. The patient was discharged.
Patient problems: Discomfort
MAUDE report 50468466 ↗MalfunctionAug 19, 2026Low impedance
It was reported on a remote transmission that the patient's left ventricular (LV) lead exhibited low pacing impedance measurement. The patient had no adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50313819 ↗MalfunctionAug 12, 2026Failure to Capture; Fracture; High impedance; Therapy Delivered to Incorrect Body Area; Low impedance
During a remote follow-up, decreased and increased pacing impedance resulting in muscle stimulation and a loss of capture (LOC) were observed on the left ventricular (LV) lead. Conductor fracture was suspected but not confirmed. The device was then programmed into right ventricle (RV) stimulation only to resolve the event. The patient is stable.
Patient problems: Discomfort
MAUDE report 50223816 ↗MalfunctionJun 25, 2026High impedance
IT WAS REPORTED DURING IMPLANT PROCEDURE THAT THE RIGHT VENTRICULAR LEAD AND LEFT VENTRICULAR LEADS DISPLAYED HIGH PACING IMPEDANCE. NEITHER WAS IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630182 ↗MalfunctionJun 10, 2026Break
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED GENERATOR EXCHANGE PROCEDURE. DURING THE PROCEDURE, THE RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE VISUALLY OBSERVED TO HAVE INSULATION BREACHES. THE LEADS WERE REPAIRED AND REMAIN IN USE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453437 ↗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 25429610 ↗DeathJun 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE OR LEAD RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 25368363 ↗InjuryMay 29, 2026Fracture; Therapy Delivered to Incorrect Body Area; Capturing Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD, RESULTING IN PHRENIC NERVE STIMULATION. A FRACTURE WAS ALSO NOTED ON THE LV LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LV LEAD. THE PATIENT¿S CONDITION WAS NOT KNOWN.
Patient problems: Discomfort
MAUDE report 25340947 ↗InjuryMay 28, 2026High impedance; Therapy Delivered to Incorrect Body Area
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE, CAUSING POCKET STIMULATION DURING UNIPOLAR PACING. THE LV LEAD WAS CAPPED AND REPLACED WITH A QUADRIPOLAR LV LEAD. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE EVENTS.
Patient problems: Discomfort
MAUDE report 25325422 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- 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
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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