FLEXTENDRecalls & reported problems across all models

We found 3 models of FLEXTEND by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,260 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2013 and Sep 16, 2026 — classified as 12 deaths, 1,888 injuries, 360 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (590 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FLEXTEND problems

FLEXTEND models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FLEXTEND® 4087

  permanent pacemaker Electrode
  5 deaths1,030 reports
• FLEXTEND® 4088

  permanent pacemaker Electrode
  2 deaths676 reports
• FLEXTEND® 4086

  permanent pacemaker Electrode
  5 deaths554 reports

Recent FLEXTEND adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 11, 2026Signal Artifact/Noise; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739845 ↗
• 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 ↗
• MalfunctionAug 21, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383821 ↗
• 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 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 ↗
• 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 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 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports