ACUITY SteerableRecalls & reported problems across all models

We found 2 models of ACUITY Steerable by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 396 adverse event reports in the FDA's MAUDE database, received between May 3, 2013 and Sep 4, 2026 — classified as 2 deaths, 302 injuries, 92 malfunctions.

The most frequently reported specific device problem is “High impedance” (101 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 Steerable problems

ACUITY Steerable models

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

• ACUITY™ Steerable 4555

  Permanent defibrillator electrodes
  2 deaths247 reports
• ACUITY™ Steerable 4554

  Permanent defibrillator electrodes
  149 reports

Recent ACUITY Steerable adverse event reports

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

• InjurySep 4, 2026Extracardiac stimulation; High Capture Threshold

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50600382 ↗
• DeathAug 6, 2026Over-Sensing; Pacing Problem

  It was reported that the patient had an ablation procedure for ventricular tachycardia (VT) on (b)(6) 2026. Subsequent to the ablation, on (b)(6) 2026, the patient was going in and out of slow VT; the cardiac resynchronization therapy defibrillator (CRT-D) was set to 100 beats/minute in an effort to pace through the VT. Burst pacing was tried and the patient's arrhythmia accelerated, requiring a shock, which successfully converted. A Lidocaine drip and propranolol were also administered. It was planned at the time to examine further medical management for the patient. The VT returned and it was observed that the left ventricular lead (LV) was inhibiting pacing. Technical Services discussed that it was likely health-related. It was further reported that this patient passed away on (b)(6) 2026. The patient was to be cremated, and it was not stated whether the device system would be returned. Additional information is being requested.

  Patient problems: Tachycardia

  MAUDE report 50165505 ↗
• InjuryJul 6, 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 25728130 ↗
• MalfunctionJun 25, 2026Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED REVIEW OF THE DEVICE DATA DUE TO CONCERNS FOR POSSIBLE LEFT VENTRICULAR (LV) LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) REVIEWED THE RECENT PRESENTING ELECTROGRAM (EGM) AND DETERMINED IT APPEARED CONSISTENT WITH LV LOC. THE HCP INDICATED THAT THE PATIENT WOULD BE BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630687 ↗
• InjuryJun 2, 2026Fracture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED FRACTURE. SUBSEQUENTLY, THIS LV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363107 ↗
• InjuryMay 5, 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 25077025 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS EXPLANTED. DUE TO THE LIMITED INFORMATION RECEIVED, FURTHER FOLLOW-UP TO OBTAIN RELATED DETAILS WAS NOT POSSIBLE.

  Patient problems: Unspecified Infection

  MAUDE report 25055216 ↗
• InjuryApr 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED DUE TO A NONSPECIFIC PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THIS LV LEAD WAS EXPLANTED DUE TO SEVERE PALPITATIONS AND ANOMALIES RELATED TO PACING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Palpitations

  MAUDE report 24933923 ↗
• InjuryJan 28, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WHICH INCLUDED A LEFT VENTRICULAR (LV) LEAD, A RIGHT VENTRICULAR (RV) LEAD, AND A NON BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD WAS SCHEDULED FOR LASER LEAD EXTRACTION BY THE PHYSICIAN AFTER PRESENTING TO THE EMERGENCY ROOM WITH COUGH AND CONGESTION AND LATER BEING FOUND TO HAVE AN INFECTION WITH E. FAECALIS BACTEREMIA, FOR WHICH ANTIBIOTICS WERE INITIATED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DEMONSTRATED VEGETATION ON THE RA LEAD, AND LEAD EXTRACTION WAS RECOMMENDED. THE DEVICE CLINIC REPORT ALSO NOTED THAT THE LV LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE GREATER THAN 3000 OHMS. THE ENTIRE SYSTEM WAS SUBSEQUENTLY EXPLANTED VIA LASER LEAD EXTRACTION, WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE NEXT COURSE OF ACTION IS PATIENT RECOVERY AND RESOLUTION OF THE INFECTION PRIOR TO REIMPLANTATION. THE SYSTEM WAS RETAINED BY THE CUSTOMER.

  Patient problems: Bacterial Infection; Cough

  MAUDE report 24205663 ↗
• MalfunctionJan 23, 2026Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED PACING IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE ON THE LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO OBSERVED POSSIBLE INTERMITTENT LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) REVIEWED AND RECOMMENDED A LEAD EVALUATION. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24165032 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS CAPPED DUE TO UNSPECIFIED REASON. A NEW LEAD WITH DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS LV LEAD WAS EXPLANTED DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 23796854 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23697199 ↗
• MalfunctionOct 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD RECORDED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND PROVIDED RECOMMENDATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23362832 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. REPORTEDLY, THE CALLER WAS ASKING FOR THE MAGNETIC RESONANCE IMAGING (MRI) CONDITIONAL OF THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23330794 ↗
• InjuryOct 10, 2025Failure to Capture; Defective Device; Device Dislodged or Dislocated; Failure to Capture; Defective Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. ANOTHER LV LEAD WAS IMPLANTED TO COMPLETE THIS PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23267695 ↗

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