NA 5867-3M (UDI 00763000059460)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00763000059460), received between Nov 30, 2021 and Feb 26, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 25 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO A BACTEREMIA INFECTION. VEGETATION WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. INTRAVENOUS ANTIBIOTICS WERE A DMINISTERED BUT THE SYSTEM WAS ULTIMATELY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 24462252 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA DUE TO ENTEROCOCCUS FAECALIS AND THE ENTEROCOCCUS SPECIES. THE PATIENT WAS T REATED WITH ANTIBIOTICS AND THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 24387042 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA DUE TO ENTEROCOCCUS FAECALIS AND THE ENTEROCOCCUS SPECIES. THE PATIENT WAS T REATED WITH ANTIBIOTICS AND THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 24387037 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH LEAD AND ADAPTOR WERE EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914685 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION OF THE POCKET. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 23621903 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23375714 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO A DUE TO A BLOOD BACTERIAL INFECTION, AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS SUBSEQUENTLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 23057552 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED DUE TO POCKET INFECTION. IT WAS NOTED THAT THE PATIENT EXPERIENCED HEMATOMA, PURULENT DISCHARGE, REDNESS, AND SWELLING. ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Hematoma; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 22964027 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO ENDOCARDITIS WITH LEAD VEGETATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Medical device site infection

  MAUDE report 22553409 ↗
• InjuryJul 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED. THE REASON FOR EXPLANTATION WAS NOT PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509974 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. DURING EXTRACTION, THE LEFT VENTRICULAR (LV) LEAD AND RIGHT ATRIAL (RA) LEAD BECAME FRAYED DUE TO CALCIFICATIONS AND WERE UNABLE TO BE FULLY EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 22412944 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ABDOMINAL POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND THE PACING LEADS AND ADAPTOR REMAIN IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 21864205 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS AFTER A GENERATOR CHANGEOUT PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A DEVICE POCKET INFECTION. THE PATIENT EXPERIENCED DISCOMFORT, EROSION, REDNESS AND WOUND DEHISCENCE AT THE POCKET SITE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 21241481 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY SIX WEEKS POST IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT. THE IPG SYSTEM AND A PREVIOUSLY CAPPED RIGHT ATRIAL (RA) LEAD WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21125314 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED DUE TO THE PATIENT PICKING OPEN THE POCKET OF AN IMPLANTABLE DEVICE, SPECIFICALLY THE AZURE XT DR. THE PATIENT EXHIBITED SYMPTOMS OF REDNESS AND WOUND DEHISCENCE. AS A RESULT, AN EXPLANTATION AND REPLACEMENT OF THE AZURE XT DR AND ALL ASSOCIATED LEADS WERE PERFORMED. THE ADAPTOR WAS ALSO EXPLANTED DUE TO THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection; Wound Dehiscence

  MAUDE report 20840977 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PREVIOUSLY CAPPED PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD ERODED THROUGH THE SKIN AND WAS THE SOURCE OF INFECTION. THE LEAD AND LEAD CAP WERE EXPLANTED AND REPLACED WITH A PREVIOUSLY CAPPED RV PACE/SENSE LEAD PLUGGED INTO THE PACE/SENSE PORT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). DETECTIONS WERE DEACTIVATED, THE HIGH VOLTAGE PORT WAS PLUGGED, AND THE SYSTEM REMAINS IN USE FOR PACING SUPPORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 20821406 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND LEAD ADAPTOR WERE REMOVED DUE TO INFECTION. IT WAS NOTED THAT VEGETATION WAS OBSERVED THROUGH A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ON THE TRICUSPID VALVE. THE PATIENT EXPERIENCED A FEVER. THE PREVIOUSLY CAPPED LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Fever; Unspecified Infection

  MAUDE report 20589754 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND NOT REPLACED DUE TO THE PATIENT EXPERIENCING AN ALLERGIC REACTION TO NICKEL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 19733831 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. IT WAS NOTED IT WAS BACTEREMIA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18756423 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO AN ONGOING INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17772893 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED, DUE TO A SUSPECTED INFECTION WI TH POCKET EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 17686750 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ENDOCARDITIS AND VEGETATION ON THEIR LEADS WHICH PROGRESSED TO SEPSIS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Sepsis

  MAUDE report 16103933 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ENDOCARDITIS AND VEGETATION ON THEIR LEADS WHICH PROGRESSED TO SEPSIS.  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Sepsis

  MAUDE report 16103833 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TEN WEEKS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) THE PATIENT DEVELOPED A POCKET INFECTION. THE IPG SYSTEM WAS EXPLANTED AND REPLACED BY AN LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15144306 ↗
• InjuryNov 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, AFTER TUNNELING OVER THE STERNUM FROM RIGHT TO LEFT TO ALLOW THE LEAD TO BE CONNECTED TO THE LEFT SIDED DEVICE, THE LEAD HAD GOTTEN 'FOLDED' SO THE TIP WAS MOVING THROUGH THE TUNNEL BACKWARDS. THE CAP THAT WAS TEMPORARILY SECURED WITH SUTURES TO THE LEAD PIN FOR THE DURATION OF THE PROCEDURE HAD PULLED OFF AND WAS MISSING FROM THE TIP OF THE LEAD. THE LEAD WAS FUNCTIONING AS EXPECTED SO THE DECISION WAS MADE TO LEAVE THE CAP IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12894535 ↗