Isoflex™ 1948-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 653 adverse event reports that list this exact device (DI 05414734502344), received between Jun 28, 2018 and Sep 28, 2026 — classified as 20 deaths, 375 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (167 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 653 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Over-Sensing

  It was reported the patient presented for a follow up in clinic. It was noted that the right ventricular lead exhibited noise over-sensing which resulted in pacing inhibition. The noise was noted to reproduced with shoulder movement. The lead was explanted and replaced with a leadless pacemaker. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910950 ↗
• InjurySep 20, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834689 ↗
• InjurySep 11, 2026Under-Sensing; Low impedance; Capturing Problem; Device Dislodged or Dislocated

  It was reported that the patient presented remotely via remote monitoring transmission. Review of the transmission noted right ventricular (RV) lead exhibited high capture threshold, low impedance, and under-sensing, which consistent to RV lead dislodgement. The RV lead dislodgement was confirmed via live fluoroscopy. Programming changes were made to address the RV lead under-sensing. Subsequently, the RV lead was capped and replaced on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726835 ↗
• InjurySep 9, 2026Over-Sensing

  It was reported that the patient presented to the clinic for a scheduled follow-up visit. Upon interrogation, the right ventricular (RV) lead exhibited noise oversensing, which resulted in pacing inhibition. The RV lead was capped and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684714 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with a pocket infection, which was identified through blood test. The physician explanted the entire system, including the pacemaker, right ventricular lead and right atrial lead. Subsequently, a new leadless dual-chamber pacemaker was implanted. The physician does not believe infection was device related. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50335832 ↗
• MalfunctionAug 13, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50241388 ↗
• MalfunctionAug 6, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160121 ↗
• InjuryAug 4, 2026Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  It was reported that the patient's pulse generator was interrogated morning after the implant procedure, and it was noted that the right ventricular (RV) lead exhibited decreased R-wave sensing value and high capture threshold. X-ray performed confirmed that the lead had dislodged. The lead was repositioned on (b)(6) 2026 and remained implanted. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125689 ↗
• InjuryJul 9, 2026Failure to Capture; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND NOISE OVERSENSING CAUSING PACING INHIBITION. THE RV LEAD WAS CAPPED AND REPLACED ON 19 JUNE 2026. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25758030 ↗
• MalfunctionJun 11, 2026Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED GENERATOR CHANGEOUT PROCEDURE ON (B)(6) 2026. DURING POCKET DISSECTION, THE PHYSICIAN VISUALLY OBSERVED AN INSULATION DEFECT ON THE RIGHT VENTRICULAR (RV) LEAD. ALL THE ELECTRICAL PARAMETERS WERE NORMAL WITH NO LEAD NOISE NOTED PRIOR TO THE PROCEDURE. THE RV LEAD WAS REPAIRED AND REMAINED IMPLANTED; THE ELECTRICAL MEASUREMENTS REMAINED CONSISTENT AND UNCHANGED POST-PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467102 ↗
• MalfunctionJun 8, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25438050 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A ROUTINE PULSE GENERATOR REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE INSULATION DAMAGE. THE RV LEAD WAS REPAIRED AND REMAINED IMPLANTED. LEAD PARAMETERS CHECKED WERE NORMAL BEFORE AND AFTER THE PROCEDURE. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250506 ↗
• MalfunctionMay 15, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25193343 ↗
• MalfunctionMay 13, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC AND NOT PACER DEPENDENT. IT WAS NOTED THAT NOISE REPRODUCIBLE WITH ISOMETRICS WAS NOTED ON HIGH VENTRICULAR RATE EPISODES ON STORED ELECTROCARDIOGRAMS (EGM) ON THE RIGHT VENTRICULAR (RV) LEAD. NO REPROGRAMMING CHANGES WERE MADE. THE PATIENT WAS TO CONTINUE BEING MONITORED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162449 ↗
• InjuryMay 12, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146563 ↗
• MalfunctionApr 20, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN PACING INHIBITION. NOISE REVERSION OCCURRED DUE TO THE NOISE OVER-SENSING. THE SENSITIVITY OF THE RV LEAD WAS INCREASED TO ADDRESS THE ISSUE AND WILL CONTINUE TO BE MONITORED. NO PATIENT SYMPTOMS OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933723 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S ENTIRE PACING SYSTEM, INCLUDING THE PACEMAKER AND THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, WAS EXPLANTED ON (B)(6) 2026 DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24903380 ↗
• DeathApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2026 DUE TO AN UNKNOWN CAUSE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848161 ↗
• MalfunctionMar 26, 2026Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED OVERSENSING NOISE. IT COULD NOT BE DETERMINED WHETHER THE NOISE WAS ATTRIBUTED TO LEAD NOISE OR ELECTROMAGNETIC INTERFERENCE ON THE PACEMAKER (PM). THE PM WAS EXPLANTED AND REPLACED ON (B)(6) 2026. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699144 ↗
• InjuryMar 18, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624977 ↗
• InjuryMar 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. DEVICE INTERROGATION NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING RESULTING IN NOISE REVERSION MODE. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624833 ↗
• InjuryMar 17, 2026Intermittent Capture; Failure to Capture

  NEW INFORMATION RECEIVED INDICATED THAT LOSS OF CAPTURE HAD BEEN PREVIOUSLY NOTED DURING A CLINIC FOLLOW-UP EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624428 ↗
• InjuryMar 11, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN EXPLANT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND EXHIBITED FAILURE TO CAPTURE. THE RV LEAD DISLODGEMENT WAS CONFIRMED WITH X-RAY. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566313 ↗
• MalfunctionMar 6, 2026High impedance

  NEW INFORMATION RECEIVED NOTES THAT THE HIGH PACING IMPEDANCE ISSUE WAS INITIALLY DISCOVERED DURING AN IN-CLINIC DEVICE CHECK. DURING THAT VISIT, THE RIGHT VENTRICULAR (RV) LEAD PACING CONFIGURATION WAS REPROGRAMMED FROM BIPOLAR TO UNIPOLAR WITH GOOD ELECTRICAL MEASUREMENTS OBTAINED. THE PHYSICIAN SUBSEQUENTLY SCHEDULED AN RV LEAD REVISION ON (B)(6) 2026. ON THE DAY OF PLANNED PROCEDURE, THE PHYSICIAN ELECTED TO ABANDON THE LEAD REVISION AND KEEP THE RV LEAD IN UNIPOLAR CONFIGURATION; THE LEAD WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530326 ↗
• MalfunctionMar 5, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED PROCEDURE. DURING THE PROCEDURE, A KINK WAS OBSERVED AT THE DISTAL END OF THE LEAD. THE LEAD WAS REMOVED AND REPLACED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516038 ↗