ACUITY™ Steerable 4555Recalls & reported problems

Summary

The FDA's MAUDE database contains 247 adverse event reports that list this exact device (DI 00802526419447), received between Jul 8, 2014 and Sep 4, 2026 — classified as 2 deaths, 187 injuries, 58 malfunctions.

The most frequently reported specific device problem is “High impedance” (65 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 247 reports, 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 ↗
• 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 ↗
• 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 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 ↗
• InjurySep 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED LEFT VENTRICULAR (LV) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PREVIOUSLY CAPPED LV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 23161816 ↗
• InjurySep 2, 2025Fracture; Defective Device; Fracture; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE FIELD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON THIS LV LEAD WAS SURGICALLY ABANDONED WAS DUE TO FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937105 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD STATED THAT THIS DEVICE HAD BEEN ACCIDENTALLY BUMPED, LEADING TO PUFFINESS AT THE IMPLANT SITE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. AS OF THIS TIME, THE LV LEAD REMAINS IN SERVICE.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22778601 ↗
• MalfunctionJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM CALLED TECHNICAL SERVICES (TS) STATING THAT "A LEAD IS NOT CONNECTING OR WORKING CORRECTLY." THE PATIENT WAS UNABLE TO EXPOUND ON THE ISSUE OBSERVED NOR WHICH LEAD WAS AFFECTED. TS REFERRED THE PATIENT TO CONSULT WITH THE DEVICE TREATING CLINIC FOR FURTHER ASSISTANCE. AT THIS TIME, NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. THE RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS REMAIN IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349829 ↗
• InjuryJun 3, 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 22138007 ↗
• InjuryMay 30, 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 22116267 ↗
• InjuryFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURE OF THIS LEFT VENTRICULAR (LV) LEAD OCCURRED DURING THE ELECTIVE DEVICE REPLACEMENT PROCEDURE. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464926 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD UNDERWENT A REVISION SURGERY IN WHICH THIS LEAD WAS UNABLE TO BE REPOSITION DUE TO THE VENOUS ACCESS BEING OCCLUDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD HAS NOT RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261227 ↗
• InjuryJan 10, 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 REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 21129685 ↗
• InjuryNov 20, 2024Adverse 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 A POCKET EROSION. REPORTEDLY, THE DEVICE WAS ERODING THROUGH THE PATIENT SKIN. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20738094 ↗
• InjuryNov 15, 2024Adverse 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. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20701080 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20584919 ↗
• MalfunctionOct 22, 2024Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED OVERSENSING AND POSSIBLE INTERMITTENT LOSS OF CAPTURE. TECHNICAL SERVICES (TS) RECOMMENDED THE PATIENT BE BROUGHT INTO THE CLINIC TO CONFIRM LV CAPTURE AS WELL AS PROGRAMMING CHANGES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506723 ↗
• MalfunctionOct 16, 2024Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Signal Artifact/Noise; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LOSS OF CAPTURE IN ALL OF THE PACING VECTORS FOR THE LEFT VENTRICULAR (LV) LEAD. NOISE WAS ALSO SEEN IN ALL SENSING VECTORS EXCEPT FOR TIP TO RING, AND SYSTEM IMPEDANCE HAS INCREASED FROM 400 OHMS TO 1600-2000 OHMS. TECHNICAL SERVICES (TS) WAS CONTACTED, AND TS DISCUSSED EVALUATING THE LV LEAD. X-RAY IMAGING WAS PERFORMED, SHOWING A CLEAR FRACTURE OF THE LV LEAD CONDUCTORS. THE LV LEAD REMAINS IN SERVICE AS THE PHYSICIAN MAKES A DECISION ON INTERVENTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467214 ↗