FLEXTEND® 4087Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,030 adverse event reports that list this exact device (DI 00802526397738), received between Jan 23, 2013 and Sep 15, 2026 — classified as 5 deaths, 859 injuries, 166 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (274 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 1,030 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead was surgically abandoned due to an unknown product performance issue. This RA lead was successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778364 ↗
• MalfunctionSep 11, 2026Signal Artifact/Noise; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739845 ↗
• InjuryAug 21, 2026Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead surgically abandoned and replaced due to an unspecified product performance issue. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380861 ↗
• InjuryAug 14, 2026Impedance Problem

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited high voltage charges after delivering a shock with low out of range impedance measurements. Technical Services (TS) was contacted and noted that there appeared to be a short and system replacement was recommended. Tachy therapy was turned off and the patient was fitted for a life vest. Subsequently, this RA lead was surgically abandoned and successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261959 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50219647 ↗
• InjuryAug 11, 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 was no additional adverse patient effects reported. The RA lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50208516 ↗
• InjuryJul 30, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead exhibited a product performance issue and was abandoned. The patient underwent a surgical intervention to implant a new lead with a pacemaker on the right side of their chest. No additional adverse patient effects were reported.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090912 ↗
• InjuryJul 29, 2026Signal Artifact/Noise; Fracture; High Capture Threshold

  It was reported that this right atrial (RA) lead exhibited noise and elevated thresholds. The lead was confirmed to be fractured via fluoroscopy. The patient underwent a medical intervention to surgically abandon the lead and implant a new product. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073729 ↗
• InjuryJul 20, 2026Fracture

  IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR (RV) LEAD REVISION PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD WAS DAMAGED IN THE PROCESS OF EXTRACTING THE RV LEAD. THE PHYSICIAN OPTED TO REMOVE THIS RA LEAD AND REPLACED IT WITH A NEW LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RA LEAD WAS RETAINED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25880485 ↗
• MalfunctionJul 6, 2026Signal Artifact/Noise; Low impedance; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW OUT-OF-RANGE RIGHT ATRIAL LEAD IMPEDANCES, WITH THE FIRST LOW IMPEDANCE DETECTED SHORTLY AFTER IMPLANTATION. THE CURRENT DEVICE ALSO REPORTED AN OUT-OF-RANGE ATRIAL PACING LEAD IMPEDANCE. FINDINGS WERE CONSISTENT WITH AN ATRIAL LEAD INSULATION BREACH ASSOCIATED WITH NOISE ON THE RA LEAD. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728117 ↗
• MalfunctionJun 30, 2026High impedance

  IT WAS REPORTED THAT THE COMMUNICATOR FOR THE PATIENT WITH THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RED CALL DOCTOR ALERT. AT THIS TIME, THE CAUSE FOR THE ALERT REMAINS UNKNOWN. THIS PACEMAKER AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD CONFIRMED THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS THAT WERE HIGH AND OUT OF RANGE. THE LOCAL COMPANY REPRESENTATIVE CONTACTED THE PATIENT TO ARRANGE A DEVICE CHECK AS SOON AS POSSIBLE; HOWEVER, THE PATIENT HAS NOT RESPONDED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673627 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD HAD EXHIBITED INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 25638543 ↗
• InjuryJun 16, 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 25524953 ↗
• InjuryJun 11, 2026Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, THE PATIENT HAD PRESENTED WITH CHEST PAIN, HEADACHE AND A RIGHT VENTRICULAR (RV) LEAD FRACTURE. THE PACEMAKER WAS NOTED TO HAVE REACHED EOL IN 2023. ONE MONTH LATER, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE, AND A DEVICE INTERROGATION CONFIRMED THE RV LEAD FRACTURE. THE PHYSICIAN ELECTED NOT TO REPLACE THE PACEMAKER AND INSTEAD PLACE AN IMPLANTABLE LOOP RECORDER (ILR) TO ASSESS THE NEED FOR PACING. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: Bradycardia; Chest Pain; Headache; Syncope/Fainting

  MAUDE report 25480720 ↗
• MalfunctionJun 9, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT TECHNICAL SERVICES (TS) WAS REQUESTED TO INTERPRET ATRIAL TACHY RESPONSE (ATR) EPISODES WHERE NOISE OVERSENSING WAS FOUND ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. TS REVIEWED AND IT WAS NOTED THAT THE NOISE WAS ABLE TO BE RECREATED WITH ISOMETRICS. TS ALSO EXPLAINED THE EFFECTS THIS COULD HAVE ON DETECTION ENHANCEMENTS; HOWEVER, NO VENTRICULAR EVENTS HAD BEEN STORED. TS NOTED THAT IF THERE WERE ANY IMPEDANCE ANOMALIES, THEN THIS COULD BE AN INDICATOR TO A LEAD ISSUE. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445998 ↗
• InjuryJun 5, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER SYSTEM EXPERIENCED BRADYCARDIA WITH HEARTH RATES OF 30 BEATS PER MINUTE (BPM). THIS LED TO TWO EPISODES OF CARDIAC ARREST, FOR WHICH MEDICATION WAS GIVEN. IN ADDITION, THIS PACEMAKER SYSTEM EXHIBITED LOSS OF CAPTURE (LOC). THIS SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 25409659 ↗
• MalfunctionMay 28, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING OF NOISY SIGNALS FOR ITS RIGHT ATRIAL (RA) LEAD. A FRACTURE WAS SUSPECTED AS THE ROOT CAUSE FOR THE NOISE BUT IT HAS NOT BEEN CONFIRMED. THE ICD HAD ITS SENSITIVITY SETTINGS REPROGRAMMED TO ELIMINATE THE OVERSENSING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325206 ↗
• MalfunctionMay 26, 2026Failure to Capture; Failure to Read Input Signal; High Capture Threshold

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM, WITH THIS RIGHT VENTRICULAR (RV) LEAD, HAD BEEN FAILING TO MEASURE THIS RV LEAD THRESHOLD DUE A TO A LOW EVOKED RESPONSE AT THE AUTOMATIC THRESHOLD TEST. TECHNICAL SERVICES (TS) NOTED A HIGH CAPTURE THRESHOLD AND RECOMMENDED RETESTING THE THRESHOLD MANUALLY AND SETTING A FIXED OUTPUT. TS ASSISTED WITH REPROGRAMMING THE DEVICE TO INCORPORATE AN APPROPRIATE SAFETY MARGIN. ISOMETRIC EXERCISES WERE SUBSEQUENTLY PERFORMED TO RULE OUT ANY LOSS OF CAPTURE (LOC) OR ARTIFACT. PRIOR TO REPROGRAMMING, TS HAD OBSERVED INTERMITTENT LOC. THE HEALTH CARE PROFESSIONAL (HCP) THEN INDICATED THAT THEY WILL FOLLOW UP WITH ELECTROPHYSIOLOGY TAKING INTO ACCOUNT THE BATTERY LONGEVITY AND ACKNOWLEDGING THE SAFETY MARGIN PRECEDENCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280422 ↗
• InjuryMay 25, 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 BACTEREMIA. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 25272196 ↗
• InjuryMay 20, 2026Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH RV PACING THRESHOLD. NO LOSS OF CAPTURE OR PATIENT SYMPTOMS. A NEW RV SEPTUM LEAD WAS IMPLANTED AT THE SAME PROCEDURE. THE PACEMAKER WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD) AFTER SEVERAL YEARS OF BEING IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226488 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25122807 ↗
• InjuryMay 7, 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. THIS RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25111164 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINIC VISIT, CHEST XRAY IMAGES SHOWED THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE NEED SURGICALLY ABANDONED AND WAS CURLED UP NEXT TO THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983049 ↗
• InjuryApr 20, 2026Impedance Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD CALLED MENTIONING HIS LEADS NEEDED TO BE CHANGED. NONETHELESS, THE PHYSICIAN WAS NOT TELLING THE PATIENT TO DO SO. TECHNICAL SERVICES REVIEWED THE SYSTEM AND NO PRIOR CALLS RELATED TO HIS IMPLANTED DEVICE WERE FOUND, SO TECHNICAL SERVICES (TS) WAS NOT EXACTLY SURE WHAT WAS GOING ON. THE RV LEAD SHOWED SHOCK IMPEDANCE VALUES WITHIN NORMAL RANGE. ADDITIONAL INFORMATION FROM THE FIELD WAS RECEIVED MENTIONING THAT THE LEAD SHOWING IMPEDANCE ISSUES WAS THE RA LEAD AND EVEN THOUGH THE RV LEAD WAS FUNCTIONING NORMALLY AND SHOCK IMPEDANCES WERE IN RANGE THE PHYSICIAN ELECTED TO REMOVED IT SINCE THEY WERE ALREADY PERFORMING AN EXTRACTION. THERE WAS A SUCCESSFUL REIMPLANT PERFORMED AFTERWARDS WITH GOOD PATIENT OUTCOMES. THE RA LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932251 ↗
• MalfunctionApr 17, 2026Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED INTERMITTENT P-WAVE UNDERSENSING WITH LOW INTRINSIC AMPLITUDE SUGGESTING POSSIBLE UNDERSENSED ATRIAL FIBRILLATION (AF). REPROGRAMMING RA SENSITIVITY TO THE MOST SENSITIVE SETTING DID NOT RESOLVE THE ISSUE. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908393 ↗