ACUITY X4 StraightRecalls & reported problems across all models

We found 2 models of ACUITY X4 Straight by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,384 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and Sep 30, 2026 — classified as 9 deaths, 1,753 injuries, 622 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (480 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 Straight problems

ACUITY X4 Straight models

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

• ACUITY™ X4 Straight 4671

  Implantable pulse generator, pacemaker (non-CRT)
  5 deaths1,875 reports
• ACUITY™ X4 Straight 4672

  Implantable pulse generator, pacemaker (non-CRT)
  4 deaths509 reports

Recent ACUITY X4 Straight adverse event reports

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

• InjurySep 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 50942570 ↗
• MalfunctionSep 28, 2026Failure to Capture; Low impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924759 ↗
• InjurySep 28, 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 50918985 ↗
• 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 infection. The patient was treated with antibiotics. There were no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50895921 ↗
• InjurySep 24, 2026High Capture Threshold

  It was reported that the patient exhibited a high left ventricular (LV) pacing threshold. This will be addressed when the system review takes place. No adverse patient effects were reported.Additional information from the field representative indicates that this left ventricular (LV) lead was explanted. A new lead was successfully implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885203 ↗
• InjurySep 23, 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 50865758 ↗
• MalfunctionSep 10, 2026Failure to Capture; High Capture Threshold

  It was reported that this left ventricular (LV) lead had high thresholds and LV loss of capture (LOC) was observed on the presenting electrogram (EGM). The programmed LV output was increased, and LV revision may be considered at battery replacement time. This LV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50704037 ↗
• InjurySep 4, 2026Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead exhibited dislodgement following implantation. Subsequently, the lead was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602273 ↗
• InjurySep 4, 2026High Capture Threshold

  It was reported that this left ventricular (LV) lead was capped due to high capture thresholds. A new LV lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602147 ↗
• MalfunctionSep 4, 2026Positioning Problem; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pericardial Effusion

  MAUDE report 50601430 ↗
• InjurySep 4, 2026Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead was explanted due to it becoming dislodged. A new LV lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601422 ↗
• InjurySep 4, 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. This LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50601346 ↗
• MalfunctionSep 4, 2026Failure to Capture

  It was reported that the health care professional (HCP) called Technical Services (TS) for further review of the presenting electrogram (EGM) due to concerns of loss of capture (LOC) on the left ventricular (LV) lead. Upon review, intermittent loss of capture (LOC) on the LV lead was observed. The HCP stated plans to schedule patient for an in clinic visit for further lead evaluation. No adverse patient effects were reported. This LV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601332 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50599859 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead had exhibited infection due to infected breast implant. As of this time, this LV lead remains in service. There was no additional adverse patient effects reported.

  Patient problems: Unspecified Infection

  MAUDE report 50566536 ↗

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