FLEXTEND® 4086Recalls & reported problems

Summary

The FDA's MAUDE database contains 554 adverse event reports that list this exact device (DI 00802526397721), received between Jan 22, 2014 and Sep 16, 2026 — classified as 5 deaths, 447 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (137 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 554 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited high out of range right atrial (RA) lead impedance measurements above 3000 Ohms. The patient reported feeling presyncope. This ICD had its programming optimized for the patients needs. This ICD system remains in service. No adverse patient effects were reported.

  Patient problems: Presyncope

  MAUDE report 50789766 ↗
• MalfunctionAug 21, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383821 ↗
• MalfunctionJul 2, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED UNDERSENSING OF THE P WAVE AND INAPPROPRIATE PACING IN THE RIGHT ATRIAL (RA) CHANNEL. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED REPROGRAMMING OPTIONS. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25694477 ↗
• MalfunctionJul 2, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISY SIGNALS. UPON REVIEW, THIS RA LEAD EXHIBITED OVERSENSING. THE RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690800 ↗
• MalfunctionJun 24, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PACEMAKER AND THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD. TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND DETERMINED THERE WAS ATRIAL PACING ON THE PRESENTING ELECTROGRAM (EGM), FOLLOWED BY VENTRICULAR SENSED BEAT WHICH INDICATED CAPTURE. HOWEVER, TS ADVISED THE HEALTH CARE PROFESSIONAL (HCP) TO HAVE CARDIOLOGY REVIEW THE PRESENTING EGM AND DETERMINE IF THIS RA LEAD WAS CAPTURING APPROPRIATELY. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612094 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO EROSION AND INFECTION. THE PATIENT EXPERIENCED EDEMA, INFLAMMATION AND SWELLING. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS CUT FROM THE TERMINAL PIN, AND THE LEAD BODY REMAINS IMPLANTED AND INACTIVE.

  Patient problems: Erosion; Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 25446917 ↗
• InjuryJun 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. THIS LEAD WAS REPLACED SUCCESSFULLY DURING A DEVICE CHANGEOUT WHEN THE PACEMAKER REACHED END OF LIFE (EOL). THIS RA LEAD HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446909 ↗
• MalfunctionMay 8, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES. THE PATIENT WAS NOTED TO HAVE TWO RA LEADS, WITH ONE CONNECTED TO THE RIGHT VENTRICULAR (RV) PORT OF THE DEVICE; HOWEVER, THE HEALTH CARE PROFESSIONAL (HCP) DID NOT CLARIFY WHICH RA LEAD WAS CONNECTED TO THE RV PORT. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED REPLACEMENT IN THE NEAR FUTURE. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128810 ↗
• DeathApr 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this right atrial (RA) lead had exhibited infection and subsequently died. A revision was performed and the LV lead, along with the right ventricular (RV) lead and RA lead were explanted. No additional adverse patient effects were reported. This RA lead was not returned for analysis. No further information was provided.

  Patient problems: Unspecified Infection

  MAUDE report 24944614 ↗
• MalfunctionApr 6, 2026Signal Artifact/Noise; High Capture Threshold

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER WANTED ASSISTANCE IN PROGRAMMING THE PACEMAKER FOR MAGNETIC RESONANCE IMAGING (MRI). REVIEW OF THE DEVICE SYSTEM DEMONSTRATED NOISE ON THE ATRIAL LEAD, ALONG WITH A HIGH THRESHOLD (5.0 V AT 0.4 MS). TECHNICAL SERVICES DISCUSSED THAT THE PACEMAKER SYSTEM WAS NO LONGER MRI CONDITIONAL DUE TO THE NON-FUNCTIONING ATRIAL LEAD AND ADVISED OBTAINING A NEW CARDIOLOGY ORDER. THE ATRIAL LEAD REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789601 ↗
• MalfunctionApr 1, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD SHOWED INTERMITTENT UNDERSENSING, AND THE PATIENT REPORTED A SHOCK AS SHOWN ON THE PROGRAMMER. THE RA LEAD SENSITIVITY WAS PROGRAMMED TO A FIXED VALUE OF 0.75 MILLIVOLTS. TECHNICAL SERVICES (TS) NOTED INTERMITTENT RA UNDERSENSING ON RHYTHMIQ EVENTS. AS OF THIS TIME, THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753991 ↗
• InjuryMar 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24658421 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT DURING A PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO A PRODUCT PERFORMANCE ANOMALY. THE RA LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THIS RA LEAD HAD EXHIBITED HIGH PACING THRESHOLDS WHICH LED THE PHYSICIAN TO PERFORM THE REVISION PROCEDURE AND CAPPED THE LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24473403 ↗
• InjuryFeb 25, 2026Signal Artifact/Noise; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LEAD DAMAGED OR CRACKED AND NOISE. A LEAD REVISION WAS PLANNED. AS OF THIS TIME, THIS RA LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447184 ↗
• MalfunctionFeb 17, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD HAD EXHIBITED NOISY SIGNAL WITH STABLE TREND. THIS RA LEAD MEASUREMENTS ARE WITHIN NORMAL LIMITS AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS RA LEAD RECORDED ELECTROMAGNETIC INTERFERENCE (EMI) ARTIFACTS. THESE ARTIFACTS WERE OVERSENSED, RESULTING IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. A LEAD REVISION WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365264 ↗
• InjuryFeb 4, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ABOVE 3000 OHMS. SUBSEQUENTLY, THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Pain

  MAUDE report 24257078 ↗
• MalfunctionFeb 3, 2026Signal Artifact/Noise; Over-Sensing; Low impedance; Material Integrity Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED LOW PACING IMPEDANCE OUT OF RANGE (OOR) MEASUREMENTS ON THE RIGHT ATRIAL (RA) LEAD, WHICH TRIGGERED TO LEAD SAFETY SWITCH (LSS) FROM BIPOLAR TO UNIPOLAR MODE. INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR)S DUE TO NOISE WAS ALSO OBSERVED PRIOR AND POST LSS. IT WAS CONFIRMED THAT THIS RA LEAD HAS AN INSULATION BREACH. FURTHER EVALUATION WAS RECOMMENDED. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252887 ↗
• InjuryJan 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS NOT WORKING ANYMORE. THIS LEAD WAS REVISED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193178 ↗
• MalfunctionJan 26, 2026Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED FAR-FIELD OVERSENSING. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183173 ↗
• MalfunctionJan 21, 2026Under-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. NO FURTHER INFORMATION WAS PROVIDED. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24138064 ↗
• MalfunctionJan 14, 2026Signal Artifact/Noise; Failure to Read Input Signal; Low impedance; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW AMPLITUDE AND LOW PACING IMPEDANCE OUT OF RANGE MEASUREMENTS. NON-PHYSIOLOGIC NOISE WAS ALSO NOTED. WHICH WAS BELIEVED TO BE CAUSED BY A LEAD INTEGRITY ISSUE AND RA LEAD REPLACEMENT WAS RECOMMENDED. CURRENTLY, THIS PRODUCT REMAIN SIN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070307 ↗
• MalfunctionJan 6, 2026Low impedance

  IT WAS REPORTED THAT FOLLOWING A REPLACEMENT PROCEDURE OF THE PREVIOUS IMPLANTED PACEMAKER DUE TO CODE 1003, INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY, A REMOTE ALERT WAS RECEIVED FOR LOW, OUT-OF-RANGE RIGHT ATRIAL (RA) LEAD PACING IMPEDANCE MEASUREMENTS (LESS THAN 200 OHMS). ADDITIONALLY, A SIGNAL ARTIFACT MONITORING (SAM) EPISODE WAS DECLARED DUE TO THIS LOW IMPEDANCE. THE PHYSICIAN WAS INFORMED AND AT THIS TIME, THIS RA LEAD REMAINS IMPLANTED AND IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977750 ↗
• InjuryDec 10, 2025High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NEW LEAD DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774356 ↗
• MalfunctionDec 4, 2025Failure to Capture; Over-Sensing; Under-Sensing; Failure to Capture; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT A REQUEST WAS MADE FOR TECHNICAL SERVICES (TS) TO REVIEW STORED ATRIAL TACHY RESPONSE (ATR) EPISODES FOR THIS PATIENT. UPON REVIEW, TS FOUND EVIDENCE OF UNDERSENSING, OVERSENSING AND POSSIBLE LOSS OF CAPTURE (LOC) OF THIS RIGHT ATRIAL (RA) LEAD. TS CONSIDERED LEAD INTEGRITY ISSUES AND LEAD DISLODGEMENT AS POSSIBLE CAUSES. ACCORDING TO THE HEALTH CARE PROFESSIONAL (HCP), A RECENT CHEST RADIOGRAPH SHOWED ATRIAL LEAD IN PROPER POSITION. TS RECOMMENDED IN PERSON EVALUATION FOR THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722506 ↗
• InjuryNov 20, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. SUBSEQUENTLY, IT WAS REPLACED WITH A DIFFERENT MODEL LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLD INCREASING OVER TIME. PHYSICIAN ELECTED TO SURGICALLY ABANDONED IT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612476 ↗