ACUITY X4 Spiral SRecalls & reported problems across all models

We found 2 models of ACUITY X4 Spiral S by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,418 adverse event reports in the FDA's MAUDE database, received between Apr 12, 2017 and Sep 30, 2026 — classified as 18 deaths, 1,593 injuries, 807 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (303 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 S problems

ACUITY X4 Spiral S models

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

• ACUITY™ X4 Spiral S 4674

  Implantable pulse generator, pacemaker (non-CRT)
  16 deaths1,975 reports
• ACUITY™ X4 Spiral S 4675

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths443 reports

Recent ACUITY X4 Spiral S adverse event reports

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

• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away on September 9th, 2026. During a routine cardiac resynchronization therapy defibrillator (CRT-D) system implant, the patient experienced cardiac arrest. The cardiac arrest occurred while this left ventricular (LV) lead was being implanted and after the right ventricular (RV) lead was implanted. Backup pacing was provided on the RV lead. Cardiopulmonary resuscitation (CPR) was given to the patient, and the patient experienced ventricular tachycardia (VT) and ventricular fibrillation (VF) several times. The field representative noted the patient was stable after the procedure. It was later reported by the field representative that the patient passed away overnight. It was noted the CRT-D was never implanted in the patient. This LV lead was an attempted implant. No additional adverse patient effects were reported.

  Patient problems: Cardiac Arrest; Tachycardia; Ventricular Fibrillation

  MAUDE report 50950617 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941339 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941282 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50940071 ↗
• MalfunctionSep 29, 2026Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead was believed to have exhibited dislodgment. The health care professional (HCP) stated they planned to bring the patient in to further investigate. This lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928248 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923949 ↗
• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50907234 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was part of a system revision due to a fall and landed on device which resulted to a pocket infection. After discussion, the physician opted to wash out the pocket. There were no additional adverse patient effects reported. This LV lead remained in service.

  Patient problems: Unspecified Infection

  MAUDE report 50903015 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) system exhibited infection. Subsequently, the device and leads were explanted. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50889337 ↗
• InjurySep 23, 2026Material Integrity Problem

  It was reported that this left ventricular (LV) lead was not successfully implanted due to the pigtail portion not straightening as intended when a Whisper wire was advanced through the distal tip, resulting in perforation of the lead insulation and exit through the insulation. This LV lead was not implanted, was replaced with a new LV lead of the same model and returned for analysis. No adverse patient effects were reported.

  Patient problems: Perforation

  MAUDE report 50871438 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was explanted due to the patient suffering an infection. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50818134 ↗
• MalfunctionSep 18, 2026Insufficient Device Problem Information

  It was reported that this Brady lead was not implanted successfully due to product performance anomaly and a new implantable lead was placed. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814614 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was part of a system revision due to infection. There were no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50797984 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was part of a system revision due to infection. There was no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50777466 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was part of a system revision due to infection. There was no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50774390 ↗

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