ACUITY™ Spiral 4593Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00802526423222), received between Jul 12, 2016 and Sep 18, 2026 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Capturing Problem” (4 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 24 most recent of 24 reports, 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 ↗
• 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 POSSIBLE INFECTION. REPORTEDLY, THE WAS PATIENT COMPLAINED OF A LARGE LUMP AT THE IMPLANT SITE AND STATED THAT THE DEVICE WAS SOMEWHAT STICKING UP. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 22116750 ↗
• InjurySep 13, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Under-Sensing; Migration; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Under-Sensing; Migration

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING DUE TO NOISE WITH HIGH WITHIN RANGE PACING IMPEDANCE MEASUREMENTS. IN ADDITION, ONE INAPPROPRIATE BURST OF ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED. THE PATIENT EXPERIENCED A LARGE AMOUNT OF WEIGHT LOSS, AS A RESULT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MIGRATED AND WAS UNSTABLE IN POCKET. HOWEVER, THE PATIENT HAD MANIPULATED THE DEVICE CAUSING NOISE RECORDED. THE RV LEAD EXHIBITED VARIABLE HIGH WITHIN RANGE PACING IMPEDANCE MEASUREMENTS. ISOMETRIC TESTS WERE PERFORMED, AND MEASUREMENTS WERE IN RANGE. THE PATIENT DECLINED THE DEVICE RELOCATION AND REMAINS UNDER MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE. IT WAS REPORTED THAT THIS RV LEAD EXHIBITED OVERSENSING DUE TO NOISE WITH PACING INHIBITION, RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SYNCOPE. RV LEAD PACING IMPEDANCE WAS ALSO FLUCTUATING BY 900 OHMS EVERY FEW DAYS WITH OUT-OF-RANGE MEASUREMENTS OBSERVED. UNDERSENSING WAS ALSO NOTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A CARDIOLOGY CONSULT AND TO POTENTIALLY REPLACE THE RV LEAD. THE RV LEAD REMAINS IN SERVICE.

  Patient problems: Syncope/Fainting; Twiddlers Syndrome

  MAUDE report 20216802 ↗
• InjuryAug 26, 2024High Capture Threshold; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072883 ↗
• InjuryJan 27, 2023Adverse 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 EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16256456 ↗
• InjuryDec 20, 2021Adverse 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 INFECTION AND SEPSIS. THE PATIENT RECEIVED ANTIBIOTICS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 13048415 ↗
• InjuryApr 13, 2021Adverse 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 WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 11660045 ↗
• InjuryApr 9, 2020Adverse 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 WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9946607 ↗
• InjuryJan 3, 2020Adverse 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 EROSION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 9546295 ↗
• MalfunctionSep 23, 2019High impedance; High impedance

  IT WAS REPORTED THAT THE LV LEAD WAS PROGRAMMED OFF AND MONITORING IS BEING CONTINUED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9104879 ↗
• InjuryAug 3, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. THE LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858230 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION 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 EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8510540 ↗
• InjuryFeb 6, 2019High Capture Threshold; High Capture Threshold

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS ABANDONED SURGICALLY DUE TO LEAD EXHIBITED HIGH PACING THRESHOLD. ADDITIONAL INFORMATION INDICATED THAT THE SPIRAL LEAD WAS REPLACED WITH ANOTHER LEAD LIKELY DUE TO ANATOMY AND LACK OF PACING VECTORS WITH THE SPIRAL LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8311096 ↗
• InjuryFeb 5, 2019High Capture Threshold; High Capture Threshold

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD EXHIBITED HIGH PACING THRESHOLD AND WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8306131 ↗
• MalfunctionJun 22, 2018Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD SLIGHTLY ELEVATED THRESHOLD THAT WAS NOTED DURING DEVICE CHANGEOUT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED OPTIONS WITH PACING SYSTEM ANALYZER (PSA). ADDITIONAL INFORMATION RECEIVED INDICATING THAT HIGH THRESHOLD WAS POSSIBLY DUE TO MICRO DISLODGEMENT BUT WAS NOT CONFIRMED. THERE WAS NO ACTION TAKEN. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629213 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. REPORTEDLY, THE PATIENT HAD AN ORAL SURGERY THAT LED TO SYSTEMIC INFECTION AND GROWTH OR VEGETATION IN THE HEART. MOREOVER, IT WAS APPARENT WHICH LEAD THE VEGETATION WAS ON. THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 7623156 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION WITH SEPSIS. REPORTEDLY, THE PATIENT'S DEVICE WAS EXTRUDING FROM THE POCKET SITE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 7433966 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION 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 EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7362521 ↗
• InjuryMar 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATES THAT THE PATIENT ALSO HAD SEPSIS. MOREOVER, THE LEFT VENTRICULAR (LV) LEAD WAS TAKEN OUT OF SERVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Discharge; Sepsis; Unspecified Infection

  MAUDE report 7358910 ↗
• InjuryJan 15, 2018Extracardiac stimulation; Capturing Problem; Device Operates Differently Than Expected; Extracardiac stimulation; Capturing Problem; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION INDICATED THAT HIGH PACING THRESHOLDS WERE OBSERVED WITH THIS LV LEAD. THRESHOLDS WERE REPORTEDLY HIGHER THAN DIAPHRAGMATIC STIMULATION THRESHOLD. THIS LV LEAD WAS ABANDONED SURGICALLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Muscle Stimulation; No Known Impact Or Consequence To Patient

  MAUDE report 7190319 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND SEPSIS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THIS LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 6935862 ↗
• InjuryOct 10, 2017Fracture; High impedance; Capturing Problem; Fracture; High impedance; Capturing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM EXHIBITED ELEVATED THRESHOLD MEASUREMENTS AND ELEVATED PACING IMPEDANCE MEASUREMENTS ON THE LEFT VENTRICULAR (LV) CHANNEL. IT WAS NOTED THAT IMPEDANCE MEASUREMENTS HAD EXCEEDED 2500 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6935590 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THE PATIENT ADVOCATE REPORTEDLY STATED THAT THERE WAS SWELLING AFTER THE NEW DEVICE WAS IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Swelling; Unspecified Infection

  MAUDE report 6556409 ↗
• InjuryJul 12, 2016Failure to Capture; Capturing Problem; Failure to Capture; Capturing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONIC HIGH THRESHOLD MEASUREMENTS SINCE IMPLANT OF THE LV LEAD AND SUBSEQUENTLY RESULTED IN PREMATURE BATTERY DEPLETION (PBD) AND COMPLETE LOSS OF CAPTURE (LOC). THE PATIENT WAS DEPENDENT ON BIVENTRICULAR PACING. AN INVASIVE PROCEDURE WAS PERFORMED. THE CRT-D WAS EXPLANTED AND REPLACED AND THE LV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5787336 ↗

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-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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-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-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.