Quickflex™ 1258T (UDI 05414734502610)Recalls & reported problems

Summary

The FDA's MAUDE database contains 996 adverse event reports that list this exact device (DI 05414734502610), received between Jun 11, 2018 and Sep 24, 2026 — classified as 26 deaths, 481 injuries, 489 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (255 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, 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 996 reports, 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 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 ↗
• 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 ↗
• MalfunctionMay 26, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING IMPEDANCE. THE PACING IMPEDANCE WAS NOTED TO HAVE INCREASED SUDDENLY BY A LARGE AMOUNT AS IDENTIFIED VIA TRANSMISSION. NO INTERVENTIONS OR CHANGES WERE REPORTED, AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277950 ↗
• InjuryMay 18, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED OVER-SENSING OF UNKNOWN CAUSE, RESULTING IN INAPPROPRIATE MODE SWITCH. MOREOVER, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING IMPEDANCE WHEN THE RING ELECTRODE WAS USED. BOTH RA AND LV LEADS WERE EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197620 ↗
• MalfunctionMay 15, 2026Break; Separation Failure

  IT WAS REPORTED THAT AFTER THE LEFT VENTRICULAR (LV) LEAD WAS SUCCESSFULLY FIXATED, THE STYLET WAS UNABLE TO BE REMOVED. THE PHYSICIAN PULLED ON THE STYLET WITH MORE FORCE AND THE LEAD WAS BROKEN AS A RESULT. THE LV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191644 ↗
• InjuryMay 14, 2026Failure to Capture; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING IMPEDANCE SINCE (B)(6) 2025, WHICH HAD GRADUALLY INCREASED OVER TIME. LOSS OF CAPTURE ON THE LV LEAD WAS ALSO NOTED. THE LV LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179053 ↗
• InjuryMay 11, 2026Fracture; High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH FRACTURE ALLEGED FROM OBSERVED HIGH PACING IMPEDANCE NOTED ON THE LEFT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137466 ↗
• InjuryMay 10, 2026Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH MUSCLE STIMULATION, DISCOMFORT AND EROSION AT DEVICE POCKET. THE GALLANT AND LEFT VENTRICULAR LEAD WERE REPOSITIONED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Discomfort; Pocket Erosion

  MAUDE report 25133756 ↗
• MalfunctionApr 29, 2026Failure to Capture; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND HIGH PACING IMPEDANCE. THE LEAD WAS NOT USED AND REPLACED DURING THE PROCEDURE. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024600 ↗
• InjuryApr 24, 2026Failure to Capture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD FAILED TO CAPTURE. FLUOROSCOPY WAS PERFORMED, NOTING LV LEAD FRACTURE. NO ABNORMALITIES WERE NOTED ON THE RV LEAD VIA FLUOROSCOPY. PROGRAMMING CHANGES WERE PREVIOUSLY MADE TO RESOLVE THE HIGH CAPTURE THRESHOLD ISSUE ON THE RV LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV AND LV LEADS. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24986827 ↗
• InjuryApr 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ATRIAL LEAD, RIGHT VENTRICULAR LEAD, AND LEFT VENTRICULAR LEAD WERE EXPLANTED FOR AN UNKNOWN REASON. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24812374 ↗
• MalfunctionApr 6, 2026Use of Device Problem

  A VOLUNTARY MEDWATCH REPORT STATED THAT THE LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO BE IMPLANTED DURING THE PROCEDURE. THE PHYSICIAN ELECTED TO USE ANOTHER LV LEAD TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796236 ↗
• MalfunctionMar 26, 2026No Apparent Adverse Event

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 24702076 ↗
• InjuryMar 17, 2026High impedance

  IT WAS REPORTED THAT THERE WAS AN EVENT OF HIGH PACING IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD, IN ADDITION THE RIGHT ATRIAL (RA) LEAD HAD LOW PACING IMPEDANCE AND NOISE. ON (B)(6) 2026, BOTH LEADS WERE CAPPED AND REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617404 ↗