ACUITY SpiralRecalls & reported problems across all models

We found 3 models of ACUITY Spiral by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 387 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Sep 18, 2026 — classified as 1 death, 327 injuries, 59 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (70 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 Spiral problems

ACUITY Spiral models

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

• ACUITY™ Spiral 4592

  Implantable pulse generator, pacemaker (non-CRT)
  1 death304 reports
• ACUITY™ Spiral 4591

  Implantable pulse generator, pacemaker (non-CRT)
  59 reports
• ACUITY™ Spiral 4593

  Implantable pulse generator, pacemaker (non-CRT)
  24 reports

Recent ACUITY Spiral adverse event reports

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

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50829482 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 50678110 ↗
• 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 ↗
• InjuryApr 17, 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 IMPLANTABLE LEADS HAD VEGETATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24909257 ↗
• 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 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD HAD ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD REMAINS IN SERVICE.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 24419419 ↗

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