Quickflex™ 1258T (UDI 05414734502603)Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 05414734502603), received between Jun 27, 2018 and Feb 5, 2026 — classified as 7 deaths, 70 injuries, 44 malfunctions.

The most frequently reported specific device problem is “High impedance” (34 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 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE WAS HIGH AND ABOVE THE UPPER LIMIT. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273999 ↗
• InjuryAug 4, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS STABLE AND DISCHARGED.

  Patient problems: Discomfort

  MAUDE report 22710357 ↗
• InjuryJul 28, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED LEFT VENTRICULAR (LV) LEAD'S REVISION PROCEDURE DUE TO HIGH CAPTURE THRESHOLDS. UPON OPENING THE POCKET, INFECTION WAS NOTED, AND THE LEFT SIDE WAS OCCLUDED. THE PHYSICIAN DECIDED TO REMOVE THE PULSE GENERATOR AND THE RIGHT ATRIAL (RA) LEAD. THE LV LEAD WAS NOT ABLE TO BE REMOVED DUE TO PATIENT'S ANATOMY AND THE PATIENT BEING DEPENDENT. A NEW CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS AND A NEW LEFT VENTRICULAR (LV) LEAD WERE IMPLANTED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 22639834 ↗
• InjuryMay 2, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THE PATIENT PRESENTED PRIOR TO PROCEDURE. UPON INTERROGATION, IT WAS DISCOVERED THE ATRIAL LEAD EXHIBITED AN INCREASED CAPTURE THRESHOLD AND THE RIGHT VENTRICULAR LEAD OVERSENSED NOISE THAT RESULTED IN PACING INHIBITION. THE RIGHT VENTRICULAR AND ATRIAL LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955567 ↗
• InjuryApr 30, 2024Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED HIGH CAPTURE THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD. ON (B)(6) 2024, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LV LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213924 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH INFECTION AND LEAD VEGETATION. THE VEGETATION WAS VISUALIZED WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY. THE PHYSICIAN EXPLANTED THE RIGHT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 19048428 ↗
• InjuryMar 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2024-36967. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REVISION OF THE LEFT VENTRICULAR LEAD DUE TO AN UNSPECIFIED PERFORMANCE ISSUE. AFTER THE CHRONIC LEFT VENTRICULAR LEAD WAS EXPLANTED, THE PHYSICIAN ATTEMPTED TO IMPLANT A NEW RIGHT VENTRICULAR LEAD. HOWEVER, THE LEAD HAD PULLED BACK AFTER THE SLITTER WAS USED DURING POSITIONING. THE LEAD WAS REMOVED, AND REPLACEMENT LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983922 ↗
• InjuryFeb 3, 2024Capturing Problem; Capturing Problem

  RELATED MANUFACTURER REPORT #: 2017865-2024-01954. IT WAS REPORTED, THAT THE PATIENT WAS DEPENDENT ON THE DEVICE FOR NORMAL FUNCTION. IT WAS NOTED, THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED ELEVATED, BUT STABLE CAPTURE THRESHOLDS. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637059 ↗
• InjuryJan 21, 2024Failure to Capture; Capturing Problem; Failure to Capture; Capturing Problem

  IT WAS REPORTED THE ABBOTT WARRANTY DEPARTMENT HAD RECEIVED INTERROGATION RECORDS DISPLAYING THE PATIENT'S LEFT VENTRICULAR (LV) LEAD HAD EXHIBITED LOSS OF CARDIAC PACING AND HIGH PACING MEASUREMENTS. THE LV LEAD WAS REPORTED TO BE REPLACED AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18549256 ↗
• InjuryJan 12, 2024Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  RELATED MANUFACTURER REFERENCE NUMBER:2017865-2024-01018. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE RIGHT VENTRICLE (RV) LEAD EXHIBITED NOISE THAT WAS OVERSENSED BY THE DEVICE AND LED TO PACING INHIBITION. ALSO, THE LEFT VENTRICULAR (LV) LEAD WAS OBSERVED WITH HIGH CAPTURE THRESHOLD. FLOUROSCOPY CONFIRMED THE LV LEAD HAD DISLODGED. BOTH RV AND LV LEADS WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504177 ↗
• MalfunctionDec 25, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED LOW IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT EXPERIENCED NO CONSEQUENCES AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18390588 ↗
• MalfunctionSep 25, 2023Low impedance; Low impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-46837. IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. TRANSMISSION REVEALED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW PACING IMPEDANCE. PROGRAMMING CHANGES WERE MADE ON THE RA LEAD AND THE LV LEAD IS BEING MONITORED WITH NO INTERVENTION. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17805642 ↗
• MalfunctionJun 26, 2023Failure to Capture; Failure to Capture

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THE RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS WERE RESPONSIBLE FOR NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) ALERTS RECEIVED FOR INTERMITTENT LOSS OF VENTRICULAR CAPTURE RESULTING FROM INCREASED CAPTURE THRESHOLDS. PROGRAMMING CHANGES WERE IMPLEMENTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206020 ↗
• InjuryMay 9, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT WHEN THE PATIENT WAS SEEN IN THE CLINIC, LOSS OF CAPTURE WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894778 ↗
• MalfunctionApr 25, 2023Break; Break

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT PRESENTED TO A LEAD REVISION PROCEDURE. PRIOR TO THE PROCEDURE, THE ATRIAL LEAD HAD EXHIBITED NOISE LEADING TO INAPPROPRIATE AUTOMATIC MODE SWITCH. DURING THE PROCEDURE, INSULATION DAMAGE WAS NOTED ON THE ATRIAL AND LEFT VENTRICULAR LEADS. THE LEADS WERE EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808218 ↗
• InjuryMar 30, 2023Failure to Capture; Fracture; High impedance; Therapy Delivered to Incorrect Body Area; Difficult to Remove; Device Dislodged or Dislocated; Failure to Capture; Fracture; High impedance; Therapy Delivered to Incorrect Body Area; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD FAILED TO CAPTURE AND EXHIBITED HIGH PACING IMPEDANCE. PROGRAMMING CHANGES WERE MADE. THE PATIENT STABLE.

  Patient problems: Discomfort; Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16641741 ↗
• InjuryJan 3, 2023Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE LV LEAD HAS PHRENIC NERVE STIMULATION IN ALL CONFIGURATIONS AT THRESHOLD LEVEL. ON (B)(6) 2022 THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 16088066 ↗
• InjuryOct 5, 2022Break; High impedance; Break; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE LEFT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE. THE PHYSICIAN DECIDED TO REPLACE THE LEAD. DURING THE PROCEDURE, THE PROXIMAL PORTION OF THE LEAD WAS BROKE. THE PHYSICIAN DECIDED TO ABANDON EXPLANTATION. THE PHYSICIAN ATTEMPTED TO PLACE THE NEW LEAD BUT THE LEAD WAS NOT REPLACED DUE TO PATIENT ANATOMY. THE PATIENT WAS STABLE AND WOULD CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544056 ↗
• InjuryOct 4, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR REPLACEMENT PROCEDURE. PRIOR TO PROCEDURE, IT WAS NOTED THAT THE LEFT VENTRICLE (LV) LEAD EXHIBITED ELEVATED CAPTURE THRESHOLD. THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15534753 ↗
• DeathSep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS:2017865-2022-22749, 2017865-2022-22753, 2017865-2022-22754. IT WAS REPORTED THAT THE PATIENT EXPIRED AND THE CAUSE OF DEATH WAS UNKNOWN. IT WAS REPORTED DURING A PRIOR REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED A FAILURE TO DELIVER SHOCK DUE TO UNDER-SENSING. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380715 ↗
• InjuryJul 29, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICLE (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127549 ↗
• MalfunctionJul 21, 2022High impedance; Therapy Delivered to Incorrect Body Area; High impedance; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO IN-CLINIC FOLLOW-UP WITH A COMPLAINT OF DIAPHRAGMATIC STIMULATION. UPON DEVICE INTERROGATION, IT WAS DISCOVERED THAT THE LEFT VENTRICULAR (LV) LEAD HAD UNDERGONE AN AUTOMATIC POLARITY SWITCH DUE TO HIGH PACING IMPEDANCE MEASUREMENTS IN BIPOLAR CONFIGURATION. PROGRAMMING CHANGES WERE MADE TO THE PACING VECTOR, AND THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort

  MAUDE report 15080636 ↗
• InjuryJul 20, 2022Intermittent Capture; Intermittent Capture

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15679. IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC WITH SYNCOPE DISCOMFORT FROM A SYNCOPE RELATED HEAD INJURY. UPON INTERROGATION, THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE EXHIBITED INTERMITTENT CAPTURE, HIGH CAPTURE THRESHOLDS, HIGH PACING IMPEDANCE, AND THE LEFT VENTRICULAR (LV) LEAD WAS ALSO FOUND TO HAVE INTERMITTENT CAPTURE, LEADING TO THE SYNCOPE AND DISCOMFORT. RV LEAD FRACTURE WAS SUSPECTED. CORRECTIVE PROGRAMMING CHANGES WERE MADE AND THE PATIENT'S SYNCOPE WAS RESOLVED. THE PATIENT WAS STABLE THROUGHOUT THE INTERVENTION.

  Patient problems: Discomfort; Syncope/Fainting

  MAUDE report 15070494 ↗
• InjuryJul 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR ATRIAL LEAD DISLODGMENT. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE LEADS WERE NOT SECURED PROPERLY TO THE POCKET AND THE LV LEAD ALSO DISLODGED. PHYSICIAN DOES NOT BELIEVE THE LEADS ARE TO BLAME FOR THE DISLODGMENTS. PATIENT CONDITION WAS STABLE. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15262.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032773 ↗
• InjuryJul 1, 2022Failure to Capture; Over-Sensing; Device Dislodged or Dislocated; Failure to Capture; Over-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE AND FAR P-WAVE OVER-SENSING. IT WAS PREVIOUSLY NOTED THAT FLUOROSCOPY WAS PERFORMED AND CONFIRMED LV LEAD DISLODGEMENT. THE LV LEAD WAS CAPPED AND REPLACED ON 29 JUN 2022. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888054 ↗