ACUITY™ Spiral 4592Recalls & reported problems

Summary

The FDA's MAUDE database contains 304 adverse event reports that list this exact device (DI 00802526423109), received between Apr 21, 2016 and Sep 7, 2026 — classified as 1 death, 253 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (55 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 304 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50643017 ↗
• InjuryJul 27, 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 50018578 ↗
• InjuryJun 30, 2026Fracture; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD OUTPUT. ULTIMATELY, THIS LV LEAD WAS ATTEMPTED TO BE EXTRACTED DURING WHICH THE LEAD BROKE. PART OF THE LEAD WAS EXTRACTED AND PART OF IT REMAINS IN THE PATIENT. A NEW LV LEAD WAS IMPLANTED AND REMAINS IN SERVICE. THE PART OF THIS LV LEAD THAT WAS EXPLANTED HAS BEEN RETURNED AND IS EXPECTED TO BE ANALYZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25673472 ↗
• InjuryJun 17, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HAD EXHIBITED RIGHT VENTRICULAR OVERSENSING AND NOISE, AS WELL AS NOISE IN THE LEFT VENTRICULAR CHANNEL. THE SYSTEM WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541533 ↗
• InjuryJun 15, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXPERIENCED A SYNCOPAL EPISODE AND WAS ADMITTED TO THE HOSPITAL. A DEVICE EVALUATION WAS PERFORMED, DURING WHICH SHOCK LEAD IMPEDANCE MEASUREMENTS WERE FOUND TO BE HIGH OUT OF RANGE. ADDITIONALLY, PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEADS WERE NOTED TO BE ELEVATED BUT REMAINED WITHIN NORMAL LIMITS. EVALUATION OF THE ELECTROLYTE LEVELS FOR THE PATIENT REVEALED FLUCTUATIONS, AND IT WAS SUSPECTED THAT THE IMPEDANCE CHANGES WERE RELATED TO PHYSIOLOGICAL FACTORS RATHER THAN A DEVICE OR LEAD ANOMALY. THE PLAN WAS TO CONTINUE MONITORING THE PATIENT. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 25513254 ↗
• InjuryJun 10, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED IN THRESHOLD MEASUREMENTS AS PER CURRENT CAPTURE. NEITHER VECTOR HAD A THRESHOLD BELOW 4 VOLTS AT 1 MILLI SECOND. IN ADDITION, AT THE HIGHER OUTPUTS; THE PATIENT EXPERIENCED STIMULATION. THE LV LEAD WAS SET TO 5 VOLTS AT 1 MILLI SECOND OUTPUT TIP TO RIGHT VENTRICULAR (RV) LEAD. AS OF THIS TIME, THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS LV LEAD WAS EXPLANTED. DURING LEAD REMOVAL, THE PATIENT'S BLOOD PRESSURE (BP) DROPPED, AND A PERICARDIAL DRAIN WAS PLACED. A NEW LEAD WAS THEN IMPLANTED; HOWEVER, THE BP REMAINED UNSTABLE. A THORACOTOMY WAS PERFORMED, AND UPON OPENING THE CHEST, A TEAR WAS IDENTIFIED IN THE MID CORONARY SINUS (CS). THE NEWLY PLACED LEAD WAS PULLED BACK DURING HEAD ROTATION. THE SURGEON SUBSEQUENTLY IMPLANTED TWO EPICARDIAL LEADS. ADDITIONALLY, THE RA LEAD DEMONSTRATED MINIMAL SENSING AND IS CURRENTLY NON-CAPTURING, LIKELY DUE TO THE SURGICAL CANNULA.

  Patient problems: Device Overstimulation of Tissue; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 25460172 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED IMPLANTABLE LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PREVIOUSLY CAPPED LEAD REMAINED CAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 25273645 ↗
• InjuryMay 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 POCKET EROSION AND SUSPECTED POSSIBLE INFECTION. THE PATIENT DESCRIBED A HOLE IN THE SKIN AT THE DEVICE SITE, ACCOMPANIED BY SIGNIFICANT BLEEDING, PRESENCE OF PUS DISCHARGE AND PAIN UPON TOUCH. THE PRIMARY CARE PROVIDER CLEANED THE SITE AND SCHEDULED A NEXT-DAY FOLLOW-UP. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: Discomfort; Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 25271747 ↗
• MalfunctionApr 11, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PRESENTING ELECTROGRAM (EGM) OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SUGGESTED THAT THERE WAS SOME LEFT VENTRICULAR (LV) LOSS OF CAPTURE; THERE WAS A SECOND SIGNAL PRESENT ON THE LV EGM THAT WASN'T PRESENT ON PREVIOUS STORED PRESENTING EGMS. THE LV AUTO THRESHOLD TEST WAS PROGRAMMED OFF AND THE LAST MEASURED THRESHOLD IN (B)(6) 2020 WAS 0.6 V @ 1.0 MS. THE CURRENT CRT-D OUTPUT WAS PROGRAMMED AT 1.5 V @ 1.0 MS. THE PHYSICIAN WAS INFORMED. THE LV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CRT-D RECENTLY ALERTED AGAIN FOR UNSUCCESSFUL LV THRESHOLD TESTING DUE TO FUSION. THE PRESENTING EGM SHOWED INTERMITTENT LOSS OF LV CAPTURE. FURTHER REVIEW OF THE CRT-D SYSTEM WAS RECOMMENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849176 ↗
• MalfunctionApr 9, 2026Signal Artifact/Noise; Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE SIGNALS ON BOTH RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD WITH ONE SIGNAL BEING OVERSENSED. THERE WAS NO PACING INHIBITION OR ASYSTOLE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835516 ↗
• InjuryMar 13, 2026High impedance; Material Integrity Problem

  IT WAS REPORTED THAT THE PROXIMAL END OF THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO LEAD BREAKAGE DURING EXPLANT ATTEMPT. THE EXTRACTED HALF OF THIS LV LEAD WAS DISPOSED. A NEW BRADY LEAD WITH A DIFFERENT MODEL WAS PLACED IN LEFT BUNDLE BRANCH AREA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.ADDITIONAL INFORMATION INDICATED THAT THE PROXIMAL END OF THIS LV LEAD WAS EXTRACTED AND DISPOSED. THIS LV LEAD EXHIBITED A SINGLE IMPEDANCE MEASUREMENT OF MORE THAN 2000 OHMS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594905 ↗
• InjuryFeb 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. REPORTEDLY, THE NEWLY IMPLANTED PRODUCT PUFFED OUT NEAR THE STITCHES AND CAUSING PAIN THEN THE PATIENT ALSO DEVELOPED A COUGH. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD REMAINS IMPLANTED.

  Patient problems: Cough; Pain; Pocket Erosion; Unspecified Infection

  MAUDE report 24275345 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24016988 ↗
• InjuryJan 8, 2026Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD. AS A RESULT, THE LV LEAD WAS CAPPED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003449 ↗
• InjuryJan 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PROBLEM. THIS LEAD REMAINS IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986578 ↗
• InjuryJan 6, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLD. THE LEAD WAS PARTIALLY EXPLANTED AND A PORTION REMAINS IMPLANTED. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23971099 ↗
• InjuryOct 27, 2025Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LEAD DAMAGE UPON REMOVAL OF THE INVOLVED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICE FROM THE IMPLANT POCKET. THIS LV LEAD WAS EXPLANTED, NOT REPLACED DUE TO CORONARY SINUS STENOSIS AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397688 ↗
• MalfunctionOct 15, 2025High impedance; Failure to Read Input Signal; High Capture Threshold; High impedance; Failure to Read Input Signal; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A GRADUAL RISE IN PACING IMPEDANCE MEASUREMENTS. PACING IMPEDANCE MEASUREMENTS ARE NOW HIGH OUT OF RANGE. TECHNICAL SERVICES (TS) ADVISED THIS LV LEAD IS ALSO EXHIBITED A RISE IN CAPTURE THRESHOLDS AND AMPLITUDE MEASUREMENTS. TS SUGGESTED THE PATIENT BE SEEN IN CLINIC FOR A LEAD EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299752 ↗
• MalfunctionSep 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED SHOCK IMPEDANCE HIGH OUT OF RANGE, THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999083 ↗
• InjuryAug 27, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD HAD TO BE EXPLANTED AND REPLACED DUE TO A UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903844 ↗
• MalfunctionAug 8, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED 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. IT WAS NOTED THAT THE PATIENT REPORTED OF NOT FEELING WELL. TS REVIEWED THE EGM AND DISCUSSED FINDINGS WITH THE HCP RECOMMENDING FOR IN PERSON CLINIC VISIT FOR FURTHER EVALUATION. AT THIS TIME, THE LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Malaise

  MAUDE report 22760422 ↗
• MalfunctionJun 24, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS OVERSENSING THE RIGHT ATRIAL (RA). THE LEAD WAS SUSPECTED TO HAVE BEEN TURNED OFF. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322055 ↗
• InjuryJun 19, 2025Unexpected Therapeutic Results; High Capture Threshold; Unexpected Therapeutic Results; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED TIP TO CAN. IT WAS NOTED THAT IMPEDANCE MEASUREMENTS WERE STABLE, AND LV THRESHOLD WAS 5V @ 1 MS. THE PATIENT WAS EXPERIENCING PAINFUL STIMULATION IN LV CONFIGURATIONS TIP TO CAN AND TIP TO RIGHT VENTRICULAR (RV). THE PHYSICIAN ELECTED PROGRAM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM TO RV ONLY AND EXTENDED THE ATRIOVENTRICULAR DELAY (AVD), AS THE STIMULATION SENSATION WENT AWAY WITH LV OFF. THE PATIENT WAS ALSO SCHEDULED FOR CHEST X-RAYS AND AN ECHOCARDIOGRAM. IT WAS NOTED THAT THE PATIENT DID WEIGHT LIFTING AND EXERCISED AGGRESSIVELY, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED OBSERVATIONS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE X-RAYS TAKEN WERE UNREMARKABLE. THIS LV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue; Pain

  MAUDE report 22290442 ↗
• InjuryJun 17, 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 A SYSTEM REVISION DUE TO INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PREVIOUSLY CAPPED LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22235750 ↗
• MalfunctionJun 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) PROVIDED REPROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133444 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0827-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55

…and 4 more.