Vaccess 7496000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741027482), received between Jan 7, 2019 and Aug 11, 2026 — classified as 2 deaths, 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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, 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• DeathAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A Patient underwent an port placement procedure using BD implanted port. Reportedly, the patient's condition began to improve in 2026, and the family requested removal of the port. According to the family, the request for removal was declined, and the patient later developed an infection, stated that puss was coming out from all over his body. The patient subsequently expired as a result of the infection.

  Patient problems: Cellulitis; Thromboembolism; Unspecified Infection

  MAUDE report 50207864 ↗
• DeathJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25635198 ↗
• InjuryMay 27, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS AND PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 25299802 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23713318 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23614057 ↗
• InjuryNov 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23563842 ↗
• MalfunctionNov 13, 2025Migration; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD MIGRATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540159 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23035064 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22975128 ↗
• MalfunctionAug 4, 2025Migration; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY REPORTED WITH MIGRATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697160 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22084059 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT ABOUT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT WAS ALLEGEDLY DEVELOPED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 21685827 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE; THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21640865 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY ONE MONTH POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED PULMONARY EMBOLISM IN UPPER LOBE SEGMENTAL ARTERY AS WELL AS IN SUBSEGMENTAL BRANCHES AND THROMBUS SURROUNDING THE PORT IN THE LOWER JUGULAR VEIN. REPORTEDLY, THE PATIENT WAS TREATED WITH BLOOD THINNERS AND A PORT REVISION SURGERY. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 19474011 ↗
• MalfunctionNov 9, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING THE PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY BROKE AND LEAKED. THE PROCEDURE WAS COMPLETED USING AN ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777635 ↗
• MalfunctionNov 9, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING THE PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY BROKE AND LEAKED. THE PROCEDURE WAS COMPLETED USING AN ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777634 ↗
• MalfunctionMay 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO THE PORT PLACEMENT, THE SHEATH TIP ALLEGEDLY BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899356 ↗
• MalfunctionFeb 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT PREPARATION OF PORT PLACEMENT, THE DEVICE SHEATH AND DILATOR WERE ALLEGEDLY FOUND TO BE CRACKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327157 ↗
• MalfunctionOct 27, 2020Fracture; Material Separation; Separation Failure; Fracture; Material Separation; Separation Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 7496000 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY EXPERIENCED FRACTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A 55 YEARS OLD FEMALE PATIENT WEIGHS 275 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10743256 ↗
• MalfunctionOct 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL 7496000 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED FLUID LEAK. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, GENDER AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10742673 ↗
• MalfunctionJan 7, 2019Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THERE WAS ALLEGED DIFFICULTY FLUSHING THE PORT AS IT BECAME BLOCKED. IT WAS FURTHER REPORTED THAT AFTER MANIPULATION AND EXTENSIVE FLUSHING, THE PORT BEGAN FUNCTIONING AND REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8223719 ↗