Quickflex™ 1258T (UDI 05414734502627)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 05414734502627), received between Dec 6, 2018 and Aug 19, 2026 — classified as 3 deaths, 30 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryApr 2, 2026Failure to Capture; Fracture; Over-Sensing; Therapy Delivered to Incorrect Body Area; Impedance Problem

  IT WAS REPORTED THAT DURING THE PATIENT'S PREVIOUS ROUTINE GENERATOR CHANGE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE FRACTURED AND WAS REPAIRED USING SURGICAL GRADE ADHESIVE. SUBSEQUENTLY, IT WAS NOTED THAT THE LV LEAD EXHIBITED LOSS OF CAPTURE, NOISE OVER-SENSING AND VARYING LOW VOLTAGE IMPEDANCE. MUSCLE STIMULATION AND PHRENIC NERVE STIMULATION WERE ALSO OBSERVED ON THE LEFT SIDE OF THE CHEST. THE LV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD ON (B)(6) 2026. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Discomfort

  MAUDE report 24765982 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED ELECTIVE REPLACEMENT PROCEDURE FOR MRI CONDITIONAL SYSTEM. DURING THE EXPLANTATION OF THE LEFT VENTRICULAR (LV) LEAD, THE SUPERIOR VENA CAVA (SVC) WAS DISSECTED BY THE EXTRACTION TOOL. THE PHYSICIAN SUCCESSFULLY REPAIRED THE TEAR DURING THE PROCEDURE. THE LV LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 23574371 ↗
• InjuryMar 18, 2025Fracture; Over-Sensing; Low impedance; Capturing Problem; Fracture; Over-Sensing; Low impedance; Capturing Problem

  IT WAS REPORTED THAT OVER-SENSING NOISE WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD DURING AN IN-CLINIC VISIT. A DECREASE IN PACING IMPEDANCE, WHICH STABILIZED, AND A SLIGHT INCREASE IN THRESHOLDS WERE ALSO NOTED. A FRACTURE WAS NOTED DURING THE REMOVAL OF THE LV LEAD. THE PATIENT WAS ASYMPTOMATIC AND STABLE BEFORE, DURING, AND POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631910 ↗
• MalfunctionApr 24, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING THE PROCEDURE, THE LEFT VENTRICULAR LEAD COULD NOT BE SEPARATED FROM THE GUIDE WIRE. THE PHYSICIAN ELECTED TO USE A DIFFERENT LEAD. AFTER CONNECTING THE NEW LEADS TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE ICD EXHIBITED A LOSS OF PACING WHICH CAUSED ASYSTOLE. IT WAS ALSO OBSERVED THE ICD OVERSENSED NOISE AND HAD A POTENTIAL PROBLEM WITH THE HEADER. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT ICD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173001 ↗
• MalfunctionMar 11, 2024Capturing Problem; Capturing Problem

  DURING A REMOTE FOLLOW UP, A HIGH CAPTURE THRESHOLD WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. A LEAD REVISION IS ANTICIPATED BUT HAS NOT YET BEEN PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE BEING MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18879923 ↗
• MalfunctionFeb 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD BECAME KINKED WHILE MANEUVERING FOR THE IMPLANT PROCEDURE. THE LEFT VENTRICULAR LEAD WAS NOT USED AND REPLACED. THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709370 ↗
• MalfunctionJan 24, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE GUIDEWIRE FAILED TO ADVANCE IN THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS NOT USED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568747 ↗
• InjuryOct 16, 2023Failure to Capture; Failure to Capture

  DURING AN IN CLINIC FOLLOW UP, A LOSS OF CAPTURE WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. DIAGNOSTIC IMAGING WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. THE LV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17942714 ↗
• InjuryOct 5, 2023Failure to Capture; High impedance; Capturing Problem; Material Split, Cut or Torn; Failure to Capture; High impedance; Capturing Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND HIGH IMPEDANCE MEASUREMENTS. NO INTERVENTION OR PATIENT CONDITION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881380 ↗
• InjuryAug 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR GENERATOR CHANGEOUT. THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. FLUOROSCOPY WAS PERFORMED AND CONFIRMED THE LV LEAD DISLODGMENT. ON (B)(6) 2023, 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 17549049 ↗
• InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-36675. IT WAS REPORTED THAT THE DEVICE HAD MIGRATED FROM THE ORIGINAL IMPLANT SITE. THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED DUE TO THE DEVICE MIGRATION. THE DISLODGMENT WAS CONFIRM WITH DIAGNOSTIC IMAGING. THE DEVICE AND LV LEAD WERE EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391099 ↗
• InjuryMay 31, 2023Failure to Capture; Failure to Capture

  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 FAILED TO CAPTURE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028640 ↗
• MalfunctionFeb 14, 2023Low impedance; Capturing Problem; Low impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND LOW IMPEDANCE. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376250 ↗
• InjurySep 7, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-21822. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS DISCOVERED THE ATRIAL LEAD WAS OVERSENSING NOISE TRIGGERING INAPPROPRIATE MODE SWITCHES AND THE LEFT VENTRICULAR LEAD EXHIBITED A FAILURE TO CAPTURE CAUSED BY DISLODGEMENT. THE ATRIAL AND LEFT VENTRICULAR LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375394 ↗
• InjuryMar 11, 2022Break; High impedance; Break; High impedance

  IT WAS REPORTED THAT DURING A REMOTE FOLLOW, HIGH PACING IMPEDANCE WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD SUSPECTED TO BE DUE TO NON-CONFIRMED LEAD DAMAGE. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13731958 ↗
• MalfunctionMar 3, 2022Break; Low impedance; Break; Low impedance

  DURING A ROUTINE DEVICE EXCHANGE, INSULATION DAMAGE WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN ATTEMPTED TO FIX THE LV LEAD, HOWEVER, AFTER THE PROCEDURE THE PACING IMPEDANCE WAS LOW AND OUT OF RANGE. LV LEAD REVISION IS ANTICIPATED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659953 ↗
• MalfunctionJan 31, 2022Therapy Delivered to Incorrect Body Area; Capturing Problem; Therapy Delivered to Incorrect Body Area; Capturing Problem

  DURING A ROUTINE DEVICE EXCHANGE, AN INCREASE IN CAPTURE THRESHOLD AND DIAPHRAGMATIC STIMULATION WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD ONCE THE NEW DEVICE WAS IMPLANTED. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392638 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED IN CLINIC WITH A HEMATOMA AND A BACTERIAL INFECTION OF THE BLOOD. THE PATIENT'S LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED. THE PATIENT WAS STABLE THROUGHOUT PROCEDURE.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 13004632 ↗
• MalfunctionJun 29, 2021Intermittent Capture; Capturing Problem; Intermittent Capture; Capturing Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-23882, 2017865-2021-23883. IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY WITH MULTIPLE NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING EPISODES ON THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE CAUSE OF THE EPISODES WAS FOUND TO BE DUE TO PARTIAL LOSS OF RIGHT VENTRICULAR CAPTURE. UPON FURTHER EXAMINATION, IT WAS NOTED THAT BOTH THE PATIENT'S RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS WERE EXPERIENCING HIGH CAPTURE THRESHOLDS AND THUS CAUSING INTERMITTENT CAPTURE. PROGRAMMING CHANGES WERE MADE ON (B)(6) 2021 WHICH RESOLVED THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084365 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND THEIR LEFT VENTRICULAR LEAD WAS REMOVED ALONG WITH THEIR IMPLANTABLE PULSE GENERATOR SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 12020546 ↗
• InjuryApr 6, 2021Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED PROGRESSIVE INCREASE IN LV THRESHOLD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622044 ↗
• InjuryApr 5, 2021High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. UPON REVIEW IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED OUT OF RANGE HIGH IMPEDANCE AND HIGH CAPTURE THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614969 ↗
• InjuryMar 1, 2021Failure to Capture; High impedance; Failure to Capture; High impedance

  DURING REMOTE MONITORING, A LOSS OF CAPTURE AND HIGH PACING IMPEDANCE WERE OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392413 ↗