ACUITY™ X4 Spiral S 4675Recalls & reported problems

Summary

The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 00802526524578), received between Jul 11, 2017 and Sep 29, 2026 — classified as 2 deaths, 276 injuries, 165 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (58 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 443 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50940071 ↗
• MalfunctionSep 29, 2026Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead was believed to have exhibited dislodgment. The health care professional (HCP) stated they planned to bring the patient in to further investigate. This lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928248 ↗
• MalfunctionSep 18, 2026Insufficient Device Problem Information

  It was reported that this Brady lead was not implanted successfully due to product performance anomaly and a new implantable lead was placed. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814614 ↗
• InjurySep 17, 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. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50797984 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this left ventricular (LV) lead had exhibited serosanguinous drainage at the incision site, accompanied by minor swelling; no odor was present. A wound dressing was applied, and prophylactic antibiotic therapy was prescribed. No additional adverse patient effects were reported. This LV lead remains in service.

  Patient problems: Fluid Discharge; Impaired Healing; Pain; Swelling/ Edema

  MAUDE report 50713288 ↗
• InjurySep 9, 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. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50688376 ↗
• MalfunctionSep 4, 2026Positioning Problem; Insufficient Device Problem Information

  It was reported that this brady lead was attempted due to unknown product performance reason. This brady lead was replaced. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pericardial Effusion

  MAUDE report 50601445 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50570037 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this left ventricular (LV) lead had an infection. A revision was performed and the cardiac resynchronization therapy defibrillator (CRT-D) with the right ventricular (RV) lead, right atrial (RA) lead and left ventricular (LV) lead were explanted. No additional adverse patient effects were reported. The LV lead was not returned for analysis.Additional information from the field indicates that the patient was prescribed antibiotics. Additionally, the patient aspirated after the procedure and subsequently passed away as a result. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50569600 ↗
• MalfunctionJul 6, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE. TECHNICAL SERVICES WAS CONSULTED AND REVIEWED THE AVAILABLE DEVICE DATA. DURING REVIEW, A GAP IN SUCCESSFUL LV AUTOMATIC THRESHOLD MEASUREMENTS WAS IDENTIFIED. IT WAS ALSO NOTED THAT THE PATIENT IS NOT PACEMAKER DEPENDENT. THE PULSE WIDTH WILL BE INCREASED TO 1.0MS. THE LV THRESHOLD WAS 2.3V. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719222 ↗
• MalfunctionJul 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS NOT IMPLANTED SUCCESSFULLY DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. THIS LEAD WAS NEVER IN SERVICE, AND A NEW LEAD WAS PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25698431 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 25648661 ↗
• MalfunctionJun 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED DUE TO UNKNOWN PRODUCT PERFORMANCE REASON. THIS LV LEAD WAS REPLACED AND NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610810 ↗
• MalfunctionJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED DUE TO UNKNOWN PRODUCT PERFORMANCE REASON. THIS LV LEAD WAS REPLACED AND NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25543050 ↗
• MalfunctionMay 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS BRADY LEAD WAS ATTEMPTED DUE TO UNKNOWN PRODUCT PERFORMANCE REASON. THIS BRADY LEAD WAS REPLACED AND NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25248284 ↗
• InjuryMay 18, 2026Failure to Capture; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED DEVICE SENSING ANOMALIES. SUBSEQUENTLY, AN X RAY IMAGE WAS PERFORMED SINCE DISLODGMENT WAS SUSPECTED, AS WELL AS LOSS OF CAPTURE (LOC). ULTIMATELY, THIS LV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25211823 ↗
• InjuryMay 14, 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. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25177225 ↗
• InjuryMay 8, 2026High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) FROM BIPOLAR TO UNIPOLAR CONFIGURATIONS DUE TO PACING IMPEDANCES MEASUREMENT OF 2003 OHMS WHICH IS CONSIDERED TO BE HIGH OUT OF RANGE. TECHNICAL SERVICES (TS) WAS CONSULTED FOR REVIEW AND PROVIDED PROGRAMMING RECOMMENDATIONS. AT THIS TIME, NO IMMEDIATE PATIENT IMPACT OR ADVERSE EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.SUBSEQUENT ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT A REPLACEMENT PROCEDURE WAS LATER PERFORMED. THIS LV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD WAS RETURNED TO FACILITY AND IS AWAITING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130208 ↗
• MalfunctionMay 6, 2026Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED A REVIEW OF REPORTS FOR THIS PATIENT WITH A LEFT VENTRICULAR (LV) LEAD. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND NOTED THERE COULD HAVE BEEN LOSS OF CAPTURE (LOC) BUT NOTED ALL OTHER PRESENTING ELECTROGRAMS (EGMS) LOOKED SIMILAR. TS NOTED THE PATIENT WAS RECENTLY SEEN IN OFFICE AND SUSPECTED THIS WAS NORMAL FOR THIS PATIENT. THIS LV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095744 ↗
• InjuryMay 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS BRADY LEAD STATED EXPERIENCING PAIN AND BLEEDING DURING RECOVERY POST DEVICE IMPLANT OR POCKET CLOSURE. THE PATIENT WAS RETURNED TO THE CARDIAC CATHETERIZATION LABORATORY, WHERE AN INCISION WAS MADE AND THE EXISTING DEVICE POCKET WAS REOPENED. THIS BRADY LEAD WAS DISCONNECTED FROM THE DEVICE, BLEEDING WAS CONTROLLED, AND THE POCKET WAS FLUSHED WITH AN ANTIBIOTIC SOLUTION. THIS LEAD WAS THEN PLACED INTO AN ANTIBACTERIAL ENVELOPE AND REPOSITIONED INTO THE POCKET, WITH IMMEDIATE PACING AND SENSING CONFIRMED. THE POCKET WAS SUBSEQUENTLY CLOSED, AND THE PATIENT WAS TRANSFERRED BACK TO RECOVERY IN STABLE CONDITION. TO DATE, THIS BRADY LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 25055220 ↗
• InjuryApr 7, 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 IMPAIRED WOUND HEALING. THE PHYSICIAN PERFORMED A POCKET REVISION DUE TO POORLY APPROXIMATED WOUND EDGES. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: Impaired Healing

  MAUDE report 24809092 ↗
• InjuryApr 7, 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. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24802735 ↗
• MalfunctionApr 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD MAY HAVE DISLODGED AFTER THE PATIENT AWOKE WITH HER LEFT ARM RAISED ABOVE HER HEAD. THE PATIENT WAS REFERRED TO A PHYSICIAN. AS OF THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801727 ↗
• MalfunctionApr 6, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) ON THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) CHANNELS, DUE TO PACING IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED TROUBLESHOOTING OPTIONS. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793359 ↗
• InjuryApr 3, 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. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24779869 ↗

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-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-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-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-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-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-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-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-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.