Isoflex™ 1944-46Recalls & reported problems

Summary

The FDA's MAUDE database contains 329 adverse event reports that list this exact device (DI 05414734502313), received between Jul 2, 2018 and Sep 28, 2026 — classified as 7 deaths, 202 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (89 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 329 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Over-Sensing

  It was reported that the asymptomatic patient presented remotely via Merlin.net. Upon review of transmission, it was found that the Right Ventricular (RV) lead exhibited oversensing noise resulted in pacing inhibition and triggering noise reversion and High Ventricular Rate (HVR) episodes. No intervention was performed. Patient condition was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916323 ↗
• InjuryAug 28, 2026Device Dislodged or Dislocated

  It was reported that patient presented to clinic and was found to have a dislodged atrial lead. The atrial lead was explanted and replaced. The patient was discharged with no reports of adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492231 ↗
• InjuryAug 25, 2026Failure to Capture

  It was reported that the patient presented to the hospital for a routine generator upgrade procedure. Prior to the procedure, interrogation of the device revealed non-capture on the right atrial (RA) lead. The RA lead was capped and replaced on (b)(6) 2026. The patient was in stable condition prior to surgery, during surgery and post-surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442534 ↗
• InjuryJul 30, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented to the clinic. Upon device interrogation, the atrial lead exhibited loss of capture. The RV lead was found to be dislodged, which was confirmed by fluoroscopy. The atrial lead was subsequently explanted and replaced. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50078642 ↗
• InjuryJul 8, 2026Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH A COMPLAINT OF DISCOMFORT. EVALUATION REVEALED INTERMITTENT STIMULATION OF THE PATIENT'S RIGHT PHRENIC NERVE BY THE RIGHT ATRIAL (RA) LEAD. FLUOROSCOPY DURING THE PROCEDURE REVEALED THAT THE RA LEAD HAD DISLODGED. THE RA LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 25756732 ↗
• InjuryApr 22, 2026Failure to Capture; Under-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DEVICE UPGRADE PROCEDURE, THE ATRIAL LEAD EXHIBITED UNDER SENSING AND FAILED TO CAPTURE. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24950104 ↗
• MalfunctionApr 1, 2026Difficult to Fold, Unfold or Collapse; Product Quality Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD COULD NOT BE IMPLANTED, POTENTIALLY DUE TO THE DISTAL SCREW AT THE LEAD TIP AND AN ISSUE WITH THE LEAD DESIGN. THE RA LEAD WAS NOT USED AND REPLACED DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750983 ↗
• 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 24699133 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH THE SKIN OF THE DEVICE POCKET APPEARING RED, SWOLLEN. AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE DEVICE WAS FOUND VISIBLE FROM THE OPENED INCISION SITE OF THE IMPLANTED DEVICE POCKET. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ PACEMAKER, RIGHT VENTRICULAR LEAD AND ATRIAL LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24301580 ↗
• MalfunctionDec 24, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY TO THE CLINIC VIA MERLIN.NET TRANSMISSION. TRANSMISSIONS SHOWED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING. NO INTERVENTION WAS REPORTED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886236 ↗
• InjuryDec 9, 2025Failure to Capture; Under-Sensing; Device Dislodged or Dislocated; Failure to Capture; Under-Sensing; Device Dislodged or Dislocated

  NEW INFORMATION RECEIVED INDICATES THAT UNDER-SENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23762704 ↗
• InjuryNov 7, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT OVER-SENSED NOISE WAS PRESENT ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS NOTED AS BEING STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23502835 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC WITH REDNESS, INFECTION AND SKIN EROSION AT DEVICE POCKET. THE INFECTION WAS NOT ASSOCIATED WITH ANY ABBOTT PRODUCT AND/OR PROCEDURE. THE PACEMAKER, RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23460745 ↗
• InjurySep 11, 2025Break; Over-Sensing; Low impedance; Break; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING, LOW PACING IMPEDANCE AND INSULATION BREACH. INFORMATION RECEIVED INDICATED THE INSULATION BREACH WAS NOTED DUE TO NOISE ON THE ATRIAL LEAD AND A DECREASE IN IMPEDANCE. THE RA LEAD WAS CAPPED AND REPLACED (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023469 ↗
• InjurySep 10, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PRESENTED TO THE HOSPITAL FOR ATRIAL LEAD REVISION PROCEDURE DUE TO HIGH CAPTURE THRESHOLD. AFTER THE PROCEDURE WAS STARTED, INFECTION WAS NOTED AT THE PATIENT'S DEVICE POCKET. THE PACEMAKER, THE RIGHT ATRIAL LEAD AND THE RIGHT VENTRICULAR LEAD WERE EXPLANTED DUE TO THE INFECTION AND WERE REIMPLANTED ON THE RIGHT SIDE. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23023032 ↗
• InjurySep 9, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  NEW INFORMATION RECEIVED INDICATES THAT THE RA LEAD WAS EXPLANTED ON (B)(6) 2025. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000578 ↗
• DeathAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DECEASED DUE TO AN UNKNOWN CAUSE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879788 ↗
• InjuryAug 3, 2025Break; Over-Sensing; Pacing Problem; Break; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL FOR LEAD REVISION. THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED OVER-SENSED NOISE RESULTING IN INAPPROPRIATE AUTOMATED MODE SWITCH (AMS) EPISODES DUE TO LEAD DAMAGE. THE RA LEAD WAS EXPLANTED AND REPLACED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22696641 ↗
• InjuryJul 11, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A RIGHT ATRIAL (RA) LEAD WAS DISLODGED. THE PHYSICIAN DECIDED TO EXPLANT THE RA LEAD AND A NEW LEAD WAS REPLACED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477342 ↗
• InjuryJun 25, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN. NET, THE RIGHT VENTRICLE (RV) EXHIBITED NOISE OVER SENSING RESULTED IN PACING INHIBITION. THE RIGHT ATRIAL (RA) LEAD HAD AN UNKNOWN MALFUNCTION. BOTH THE RA AND RV LEADS WERE CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS RECOVERING POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325966 ↗
• MalfunctionJun 23, 2025Break; Over-Sensing; Break; Over-Sensing

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT LEAD DAMAGE WAS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307864 ↗
• InjuryMay 20, 2025Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT PROCEDURE. THE FOLLOWING DAY, HIGH CAPTURE THRESHOLD AND DECREASED SENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. AN X-RAY WAS PERFORMED, AND DISLODGEMENT WAS CONFIRMED ON THE LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RA LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054054 ↗
• InjuryMay 20, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT A PATIENT PRESENTED TO HOSPITAL FOR A PACEMAKER UPGRADE TO CARDIAC RE-SYNCHRONIZATION THERAPY. DURING DEVICE-BASED TESTING IN PRE-OPERATION, IT WAS OBSERVED THE ATRIAL LEAD FAILED TO CAPTURE. CONCURRENTLY, THE PHYSICIAN ELECTED TO CAP AND REPLACED THE ATRIAL LEAD ON (B)(6) 2025. THE NEW PACEMAKER AND ATRIAL LEAD WERE SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050172 ↗
• MalfunctionMay 9, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A GENERATOR REPLACEMENT PROCEDURE. AFTER THE POCKET WAS OPENED, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) FAILED TO SENSE. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991489 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO INFECTION AT THE DEVICE SITE. THE PACEMAKER, RIGHT ATRIAL LEAD, RIGHT VENTRICULAR LEAD AND RIGHT VENTRICULAR CAPPED LEAD WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 21931900 ↗