ACUITY X4 Spiral LRecalls & reported problems across all models

We found 2 models of ACUITY X4 Spiral L by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 900 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2017 and Sep 30, 2026 — classified as 4 deaths, 553 injuries, 343 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (158 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 ACUITY X4 Spiral L problems

ACUITY X4 Spiral L models

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

• ACUITY™ X4 Spiral L 4677

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths729 reports
• ACUITY™ X4 Spiral L 4678

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths171 reports

Recent ACUITY X4 Spiral L adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited high out of range impedance measurements for its left ventricular (LV) lead. Additionally it exhibited high out of range shock impedance measurements for its right ventricular (RV) lead. Technical Services (TS) was consulted discussed the limits for the impedance measurements as well as alert options for out of range impedance measurements. The calling clinician stated that the RV lead was changed to single coil configuration so it was back within established limits. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947728 ↗
• InjurySep 28, 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 50910881 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50784374 ↗
• MalfunctionSep 15, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774138 ↗
• MalfunctionSep 4, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610446 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  It was reported that this left ventricular (LV) lead was explanted due to an unknown product anomaly. A new lead was successfully implanted. No additional adverse patient effects were reported. This LV lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602289 ↗
• MalfunctionSep 4, 2026Failure to Capture; Positioning Problem

  It was reported that this patient was scheduled for a cardiac resynchronization therapy defibrillator (CRT-D) upgrade procedure with conduction system pacing (CSP) lead placement. There was difficulty positioning this CSP lead, and there was no capture in the one available branch. Subsequently this LV lead was removed, and the procedure was completed with connecting the chronic right ventricular (RV) defibrillation lead to a new implantable cardioverter defibrillator (ICD) instead. No adverse patient effects were reported. This lead will not be returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600921 ↗
• InjuryAug 21, 2026Insufficient Device Problem Information

  It was reported that this left ventricular (LV) lead was attempted due to an unknown circumstances. The replacement procedure was successfully performed with another Non-Boston Scientific lead that was successfully implanted instead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380868 ↗
• MalfunctionAug 20, 2026Failure to Capture; High Capture Threshold

  It was reported that the cardiac resynchronization therapy defibrillator (CRT-D) and this left ventricular (LV) lead exhibited a loss of capture. There was a high capture threshold on this LV lead. Technical Services (TS) recommended in clinic threshold testing. This LV lead remains in service. No adverse patient effects were reported.Additional information was received. It was reported that the health care professional (HCP) planned to do an LV lead revision. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360096 ↗
• InjuryAug 20, 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 50343448 ↗
• MalfunctionAug 19, 2026Pacing Problem

  Patient problems: Asystole; Bradycardia

  MAUDE report 50329752 ↗
• InjuryAug 17, 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 50274602 ↗
• MalfunctionAug 10, 2026High impedance

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) exhibited high out of range pacing impedance measurements for its left ventricular (LV) lead, which resulted in its lead safety switch (LSS) to be activated. Technical Services (TS) was consulted and discussed stored data, with the latest data indicating the pacing impedance measurements back in range and all other measurements were within range. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197008 ↗
• MalfunctionAug 10, 2026Difficult to Insert; Insufficient Device Problem Information

  It was reported that this left ventricular (LV) lead was attempted due to unknown product performance reason. This LV lead was replaced and not implanted. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189527 ↗
• InjuryJul 30, 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 50079098 ↗

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