ACUITY™ Spiral 4591Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00802526422980), received between Oct 11, 2016 and Sep 8, 2026 — classified as 52 injuries, 7 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 50678110 ↗
• 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 ↗
• 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 ↗
• InjurySep 6, 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 LV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 22987244 ↗
• MalfunctionJul 16, 2025Failure to Capture; Failure to Read Input Signal; Failure to Capture; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED SUSPECTED LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED POSSIBLE FUSION BEATS, HOWEVER LOC COULD NOT BE DISCARDED AND FURTHER IN OFFICE EVALUATION OF THE SYSTEM WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522764 ↗
• MalfunctionJul 15, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THERE WERE CONCERNS THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) STATED THAT A CLINIC EVALUATION WILL CONFIRM CAPTURE. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512380 ↗
• InjuryJan 10, 2025High Capture Threshold; Migration; High Capture Threshold; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD HAD OCCLUDED VEINS AND EXHIBITED A HIGH THRESHOLD. ADDITIONALLY, THERE WAS AN EVIDENCE OF LV LEAD MIGRATION. THE LV LEAD WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 21123820 ↗
• InjuryDec 17, 2024Failure to Capture; Low impedance; High Capture Threshold; Failure to Capture; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND HIGH THRESHOLDS. ADDITIONALLY, IT WAS NOTED THAT THE LV PACING LEAD IMPEDANCE MEASUREMENTS HAVE DECREASED OVER THE LAST YEAR MEASURING FROM 550 OHMS TO 400-450 OHMS. NO OBSERVATIONS OF NOISE WERE FOUND. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION AND THE DEVICE WAS RE-PROGRAMMED. THE PROGRAMMER SHOWS THE LONGEVITY DROPPED FROM FIVE YEARS TO THREE YEARS WITH RE-PROGRAMMING IN WHICH THE HEALTH CARE PROFESSIONAL (HCP) WILL CONSULT WITH THE PHYSICIAN. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20956380 ↗
• InjuryOct 25, 2024Adverse 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 POCKET EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PREVIOUSLY CAPPED LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20536395 ↗
• InjuryJun 19, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS. THIS LV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568042 ↗
• InjuryMar 23, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED AND REPLACED. ADDITIONAL INFORMATION FROM THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATES THIS LEAD WAS REPLACED DUE TO HIGH THRESHOLD MEASUREMENTS. IT WAS NOTED THAT THE HIGH LV THRESHOLD MEASUREMENTS WERE BELIEVED TO BE RELATED MORE TO THE QUALITY OF THE PATIENTS HEART TISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965408 ↗
• MalfunctionFeb 14, 2024Failure to Capture; Failure to Read Input Signal; Failure to Capture; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) REVIEWED THE PRESENTING ELECTROGRAM (EGM) IN WHICH IT APPEARED THAT THE DEFLECTIONS WERE LATE. AN ALERT FOR LEFT VENTRICULAR AUTOMATIC THRESHOLD (LVAT) GREATER THAN PROGRAMMED AMPLITUDE WAS OBSERVED IN ADDITION. TS RECOMMENDED BRINGING THIS PATIENT IN FOR FURTHER LV LEAD EVALUATION. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708378 ↗
• InjuryFeb 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO IT WAS FRACTURED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637794 ↗
• MalfunctionJan 16, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS SYSTEM WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS SHOWED A GRADUAL INCREASE IN LV PACING IMPEDANCES FROM WITHIN RANGE VALUES TO HIGH, OUT OF RANGE AT THE TIME OF THE CALL. ALSO, THERE WAS NON-SUSTAINED VENTRICULAR TACHYCARDIA WITH FINE NOISE ON THE RV CHANNEL WITH NO PAUSES GREATER THAN TWO SECONDS. TECHNICAL SERVICES RECOMMENDED ISOMETRICS WITH POCKET MANIPULATION, COUGHING AND DEEP BREATHING WHILE SAMPLING IMPEDANCE. THE PATIENT IS PACING DEPENDENT BUT NO SYMPTOMS POST-SURGICAL PRODUCED AND THEY WERE NOT ABLE TO DO THE TESTING AT THE MOMENT. THE CRT-D, RV AND LV LEADS REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515477 ↗
• InjuryAug 29, 2023Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND IMPEDANCE ISSUES. SUBSEQUENTLY, THE LEAD WAS SURGICALLY ABANDONED AND REPLACED, AND THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643323 ↗
• MalfunctionJun 22, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED, THAT THIS LEFT VENTRICULAR (LV) LEAD. EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE. IT WAS NOTED, THAT THE THRESHOLD WAS SLIGHTLY ELEVATED. THE CAUSE OF THE HIGH OUT OF RANGE IMPEDANCE IS UNKNOWN. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPROGRAMMED. AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181071 ↗
• InjuryMar 10, 2023High Capture Threshold; Migration; High Capture Threshold; Migration

  IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD WAS NON-FUNCTIONAL AND EXHIBITED HIGH PACING THRESHOLD. ADDITIONALLY, CHEST X-RAY CONFIRMED THAT THE LV LEAD HAD MOVED AND SOUNDS LIKE SOME CHANGES WERE MADE. TO DATE, THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE LEAD HAD MIGRATED BUT IS STILL WITHIN THE TARGET BRANCH. ALSO, THE DEVICE WAS REPROGRAMMED TO RIGHT VENTRICULAR (RV) ONLY. THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522222 ↗
• InjuryDec 20, 2022Failure to Capture; Defective Device; No Apparent Adverse Event; Failure to Capture; Defective Device; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014104 ↗
• InjurySep 20, 2022Adverse 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 FULL SYSTEM EXPLANT DUE TO INFECTION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15456334 ↗
• InjuryJun 16, 2022Adverse 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 BACTERIAL INFECTION WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD REMAINS IN SERVICE.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 14712034 ↗
• InjuryJun 15, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED. IT WAS DAMAGED DURING THE CHANGEOUT OF THE DEVICES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691515 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INFECTION WITH SEPSIS AND WAS PART OF THE SYSTEM REVISION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 14582616 ↗
• InjuryMay 27, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO RISING THRESHOLDS SINCE LEAD WAS NOT IN AN OPTIMAL LOCATION. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14529735 ↗
• InjuryApr 9, 2022Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBTIED HIGH OUT OF RANGE IMPEDANCE ISSUE DUE TO A SUSPECTED FRACTURE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO RIGHT VENTRICULAR (RV) LEAD ONLY UNTIL THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO ABANDON THE LV LEAD AND IMPLANT A NEW PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068043 ↗
• InjuryFeb 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE DISLODGED. THE LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13462223 ↗

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-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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• 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-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-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-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-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-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-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-0826-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha

…and 4 more.