ACUITY™ Steerable 4554Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 00802526419324), received between May 3, 2013 and Jun 2, 2026 — classified as 115 injuries, 34 malfunctions.

The most frequently reported specific device problem is “High impedance” (36 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 149 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• InjurySep 4, 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. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22967672 ↗
• MalfunctionJul 28, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND IN OFFICE TESTING OF THE PACING VECTORS WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629536 ↗
• InjuryJul 4, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD. THIS LV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403831 ↗
• InjuryJun 19, 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. THE PHYSICIAN OPTED TO PLACE A SMALL DEVICE PASSING THROUGH THE GROIN AND PLACING IT CLOSE TO THE HEART WHILE WAITING FOR THE INFECTION TO CLEAR UP BEFORE IMPLANTING A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 22290067 ↗
• InjuryMay 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21955395 ↗
• MalfunctionApr 24, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE DATA WAS REVIEWED BY THE HEALTH CARE PROFESSIONAL (HCP) POST EVENT AND FOUND THAT THE IMPEDANCES WERE BACK IN RANGE. THE PATIENT REMAINS UNDER MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900661 ↗
• InjuryApr 9, 2025Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXPERIENCED SENSATION NEAR THE DEVICE AND DOWN THE LEAD. TOUCHING AND PRESSING THE AREA FEELS LIKE AN ELECTRICAL SHOCK. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT WAS A POSSIBLE INSULATION EXPOSURE RESULTING IN STIMULATION. THE WHOLE SYSTEM WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Inappropriate Device Stimulation of Tissue; Unspecified Infection

  MAUDE report 21806153 ↗
• InjuryMar 10, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT DURING A GENERATOR CHANGE PROCEDURE, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) AND HIGH PACING THRESHOLDS. UNDER FLUOROSCOPY THE LEAD APPEARED TO HAVE PERFORATED IN THE EPICARDIAL SPACE. THE PHYSICIAN OPTED TO SURGICALLY ABANDON THE LV LEAD AND REPLACED IT WITH A NEW LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Perforation

  MAUDE report 21560566 ↗
• MalfunctionFeb 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE LEFT VENTRICULAR (LV) PACING LEAD IMPEDANCE MEASUREMENTS MEASURING 3,000 OHMS. SUBSEQUENTLY, THE DEVICE WAS PROGRAMMED TO RIGHT VENTRICULAR (RV) ONLY AND BI V TRIGGER WAS TURNED OFF. AT THIS TIME, THE DEVICE AND LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458215 ↗
• MalfunctionFeb 10, 2025Failure to Capture; High impedance; Over-Sensing; Failure to Capture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR REVIEW OF A PRESENTING ELECTROGRAM (EGM). TECHNICAL SERVICES (TS) REVIEWED THE DATA AND FOUND THERE IS INTERMITTENT LEFT VENTRICULAR (LV) LOSS OF CAPTURE. ADDITIONALLY, THE LV IMPEDANCES HAVE INCREASED FROM 400 OHMS RANGE TO OVER 1,456 OHMS OVER THE PAST YEAR. TS RECOMMENDED FURTHER TESTING OF THE LV LEAD. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344559 ↗
• InjuryJan 9, 2025Failure to Capture; Failure to Read Input Signal; High Capture Threshold; Failure to Capture; Failure to Read Input Signal; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD HAD A HISTORY OF INTERMITTENT LOSS OF CAPTURE (LOC) AND ELEVATED THRESHOLD MEASUREMENTS. THE PATIENT HAD PREMATURE VENTRICULAR CONTRACTIONS (PVCS), HOWEVER NORMAL PACING WAS OBSERVED SHORTLY AFTERWARDS. THERE DID NOT APPEAR TO BE FUSION. THERE WAS A SLIGHT WIDER MORPHOLOGY NOTED WITH LOC. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THE LV WAS CURRENTLY PROGRAMMED FROM LV RING TO RV. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS LV WAS SURGICALLY ABANDONED AND REPLACED DUE TO HIGH THRESHOLDS. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DURING THE SAME PROCEDURE DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118381 ↗
• InjuryNov 6, 2024Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS CAPPED DUE TO BEING DISLODGED LEADING TO LOSS OF CAPTURE. THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621766 ↗
• InjuryOct 29, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE ON ALL VECTORS. THE PHYSICIAN OPTED TO SURGICALLY ABANDON AND REPLACE THIS LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20562268 ↗
• InjuryAug 27, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED FLUCTUATING LV IMPEDANCE MEASUREMENTS IN AUGUST 2024 FROM A BASELINE OF 700-900 OHMS TO HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. THIS LEFT VENTRICULAR (LV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080736 ↗
• InjuryAug 22, 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 INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 20031784 ↗
• MalfunctionAug 22, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS, AND A LV LEAD SAFETY SWITCH (LSS) WAS TRIGGERED DUE TO A HIGH OUT-OF-RANGE LV PACE IMPEDANCE MEASUREMENT OF 2,016 OHMS. LV IMPEDANCE MEASUREMENTS HAVE BEEN FAIRLY STABLE SINCE A RECENT DEVICE CHANGEOUT IN MAY, WITH A GRADUAL INCREASE IN IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. IT WAS RECOMMENDED TO BRING THE PATIENT INTO THE CLINIC FOR LV LEAD EVALUATION TO RULE-OUT POSSIBLE LEAD INTEGRITY CONCERNS, ASSESS LV LEAD VECTORS, AND CONSIDER RAISING THE IMPEDANCE ALERT VALUE. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026049 ↗
• InjuryAug 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD WAS EXPERIENCING PHRENIC NERVE STIMULATION AND CHEST DISCOMFORT. THE PHYSICIAN DECIDED TO EXPLANT THE LEAD, DURING THE PROCEDURE THE LEAD BROKE AND WAS UNABLE TO BE FULLY EXTRACTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue; Discomfort; Foreign Body In Patient

  MAUDE report 19940921 ↗
• InjuryJul 11, 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 INFECTION AND ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 19726999 ↗
• InjuryJun 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO FRACTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621619 ↗
• InjuryJun 14, 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 INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 19536254 ↗
• InjuryApr 19, 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 EXPLANTED DUE TO UNKNOWN ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142019 ↗