FLEXTEND® 4088Recalls & reported problems

Summary

The FDA's MAUDE database contains 676 adverse event reports that list this exact device (DI 00802526397745), received between Jan 23, 2013 and Sep 15, 2026 — classified as 2 deaths, 582 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (179 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 676 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026High Capture Threshold

  It was reported that this right ventricular (RV) lead exhibited high capture thresholds. The physician opted to replace this lead due to the patient being dependent on pacing. This lead was surgically abandoned and successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775866 ↗
• InjurySep 9, 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 50686916 ↗
• 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 RV lead was explanted and successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260566 ↗
• 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 50219648 ↗
• InjuryJul 29, 2026Signal Artifact/Noise; Fracture; High Capture Threshold

  It was reported that this right ventricular (RV) 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 50073690 ↗
• InjuryJul 29, 2026High Capture Threshold

  It was reported that this right ventricular (RV) lead was surgically abandoned due to high thresholds. It was noted the patient was dependent on RV pacing. This RV lead was successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068571 ↗
• MalfunctionJul 1, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM WAS TO GO UNDERGO A MAGNETIC RESONANCE IMAGING (MRI). TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED HOW IT WAS NON MRI CONDITIONAL DUE TO ITS RIGHT VENTRICULAR (RV) LEAD AND HOW ITS RV LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THE CALLING HEALTH CARE PROFESSIONAL (HCP) WAS AWARE THE SYSTEM WAS NOT MRI CONDITIONAL AND THE MRI WAS GOING TO BE PERFORMED WITH APPROPRIATE ORDERS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682410 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25638519 ↗
• InjuryJun 16, 2026Signal Artifact/Noise; Low impedance; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASED PACING IMPEDANCE AND NOISY SIGNALS. DURING A DEVICE CHANGEOUT, INSULATION DAMAGE WAS OBSERVED ON THIS LEAD. AS THE PATIENT DID NOT WANT TO REPLACE THE LEAD, THE LEAD WAS REPROGRAMMED OFF WITH THE NEWLY IMPLANTED DEVICE. THE LEAD REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520894 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT EXPERIENCED A SYSTEM INFECTION. WHEN REMOVING THE SYSTEM, IT WAS NOTED RIGHT VENTRICULAR LEAD VEGETATION AND FIBROSIS, RESULTING ON MODERATE TRICUSPID REGURGITATION. THESE PRODUCTS WERE KEPT UNDER THE FACILITY POSSESSION, AND ALL THE SYSTEM WERE REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fibrosis; Unspecified Infection; Valvular Insufficiency/ Regurgitation

  MAUDE report 25494374 ↗
• MalfunctionMay 29, 2026Over-Sensing; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED T WAVE OVERSENSING AND ONE UNDERSENSED R WAVE IN THE RIGHT VENTRICULAR (RV) CHANNEL. ADDITIONALLY, IT WAS NOTED THAT THE R WAVES APPEARED TO BE VARIABLE. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED POSSIBLE REPROGRAMMING OPTIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340326 ↗
• 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 25122301 ↗
• InjuryMar 26, 2026High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE HIGH PACING THRESHOLDS. A NEW RV LEAD WAS IMPLANTED AS A REPLACEMENT SUCCESSFULLY. THIS RV LEAD HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706039 ↗
• InjuryMar 23, 2026Signal Artifact/Noise; Failure to Read Input Signal; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT NOISY SIGNALS PRE-OPERATION REVIEW. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT REVIEWED THE REMOTE MONITORING SYSTEM REPORT INDICATING RV OR SINGLE CHAMBER INTRINSIC AMPLITUDE OUT OF RANGE ALERT FOR THIS RV LEAD AND STATUS INDICATORS BUT NO REVIEW NOR NOTES RELATING TO NOISE AND ADVISED TO CONTACT THE PHYSICIAN WHO NOTED THE NOISE FOR REVIEW OF PHYSICIAN ANALYSIS, PATIENT PLAN AND CARE. AS OF THIS TIME, THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS RV LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A DIFFERENT MODEL. THE NOISY SIGNALS WERE DUE TO LEAD DISLODGEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670569 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24592451 ↗
• MalfunctionMar 10, 2026Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED RIGHT VENTRICULAR (RV) LEAD OVERSENSING. THE PATIENT WAS IN ATRIAL FIBRILLATION/FLUTTER. ADDITIONALLY, ELECTROGRAM (EGM) REVIEW SHOWED RIGHT VENTRICULAR (RV) LEAD SIGNALS LINED UP WITH THE RIGHT ATRIAL (RA) CHANNEL, WITH LARGER DISCREET RV SIGNALS THAT WERE LIKELY TRUE RV EVENTS. RV SENSITIVITY WAS PROGRAMMED TO 5MV IN JUNE OR JULY 2018. SIMILAR OVERSENSING WAS ALSO OBSERVED IN MAY 2018, SHORTLY AFTER IMPLANT. THERE WAS NO INDICATION OF PACING PAUSES GREATER THAN TWO SECONDS, AND THE PATIENT'S INTRINSIC RHYTHM WAS OBSERVED FREQUENTLY ENOUGH. REVIEW OF DAILY MEASUREMENTS NOTED R-WAVES BELOW BELOW 2-3 MV. ADDITIONAL INFORMATION RECEIVED EIGHT YEARS LATER REPORTED THAT THIS PACEMAKER SYSTEM STORED ADDITIONAL VENTRICULAR EVENTS CONTAINING OVERSENSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565326 ↗
• InjuryMar 6, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR (RV) LEAD WAS BELIEVED TO HAVE FRACTURED DUE TO EXHIBITED HIGH OUT OF RANGE IMPEDANCES, OVERSENSING NOISE AND HIGH THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED WHERE THIS RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS RETAINED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24538152 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531312 ↗
• MalfunctionMar 4, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED SYNCOPE. TECHNICAL SERVICES (TS) WAS CONTACTED TO REVIEW THE AVAILABLE INFORMATION, UPON REVIEW, NO EPISODES WERE NOTED TO BE STORED RELATED TO THE SYNCOPAL EVENT WHICH MADE THE HEALTH CARE PROFESSIONAL BELIEVE THE SYNCOPE WAS RELATED TO A NEUROLOGIC EVENT AND NOT TO DEVICE PERFORMANCE; HOWEVER, TWO EPISODES OF OVERSENSED NOISE IN THE RIGHT VENTRICULAR (RV) CHANNEL WERE OBSERVED TWO DAYS PRIOR. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507308 ↗
• InjuryFeb 25, 2026Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO PRODUCT PERFORMANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447562 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24380606 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24202442 ↗
• MalfunctionJan 12, 2026Signal Artifact/Noise; Over-Sensing; Impedance Problem

  IT WAS REPORTED THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. TECHNICAL SERVICES (TS) REVIEWED THAT THE RV LEAD IMPEDANCE WAS AT 450-1800 OHMS AND HAS LEAD INTEGRITY ANOMALY. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE SOURCE OF NOISE WAS UNDETERMINED. ALSO, THE NOISE WAS OVERSENSING BUT THIS DID NOT INHIBIT ANY FUNCTION AS THE PATIENT WAS PACING IN THE ATRIUM AND VENTRICLE AT 0%. THE PHYSICIAN PLANNED TO CONTINUE MONITORING THE PATIENT DUE TO LOW PACING PERCENTAGES. THERE WAS NO IMMEDIATE NEED FOR LEAD REVISION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049972 ↗
• InjuryDec 11, 2025Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RED ALERT DUE TO HIGH PACING IMPEDANCE OUT OF RANGE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS OBTAINED; THE LEAD WAS FOUND TO BE FRACTURE AND EXHIBITED LOSS OF CAPTURE (LOC); THE LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783193 ↗
• InjuryDec 2, 2025Signal Artifact/Noise; High Capture Threshold; Signal Artifact/Noise; High Capture Threshold

  IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT, IT WAS OBSERVED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH THRESHOLD, LIKELY DUE TO THE AGE OF THE LEAD. ADDITIONAL INFORMATION INDICATES THAT THE NOISE AND SAM EVENTS SUGGEST A POTENTIAL LEAD ANOMALY. FURTHERMORE, THIS RV LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD OF A DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE EFFECTS ON THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701256 ↗