Vaccess 7360000Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00801741027437), received between Jul 2, 2018 and Jul 6, 2026 — classified as 1 death, 23 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25716580 ↗
• InjuryMar 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24700316 ↗
• DeathMar 16, 2026Device Appears to Trigger Rejection; Adverse 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 AND THROMBOSIS. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 24602736 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT AN IMPLANTED PORT PLACEMENT PROCEDURE USING VACCESS CT LOW-PROFILE PORT. SOMETIMES POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED INFLAMMATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 24160530 ↗
• InjuryJan 14, 2026Adverse 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24064721 ↗
• InjuryDec 18, 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 23836022 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23520087 ↗
• InjuryNov 7, 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 23495826 ↗
• InjurySep 8, 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 EXPERIENCED WITH UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22989889 ↗
• InjuryAug 29, 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 22920579 ↗
• InjuryAug 28, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION AND RISK OF DEEP VEIN THROMBOSIS. THE DEVICE ALLEGEDLY REPORTED WITH FRACTURED PORT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22910559 ↗
• InjuryAug 21, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22857737 ↗
• InjuryAug 5, 2025Migration; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER DISLODGED, AND PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22711585 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE MONTH FOUR DAYS POST PORT PLACEMENT PROCEDURE FOR CHEMOTHERAPY TREATMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22711181 ↗
• InjuryJul 31, 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 DEVELOPED WITH UNSPECIFIED INFECTION AND NEUTROPENIA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Low White Blood Cell Count; Unspecified Infection

  MAUDE report 22673375 ↗
• InjuryJul 28, 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 22628773 ↗
• InjuryJul 24, 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 22589258 ↗
• InjuryFeb 19, 2025Obstruction of Flow; Expulsion; Obstruction of Flow; Expulsion

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PORT ERODED. PATIENT HAD ALSO DEVELOPED WITH INFECTION, THROMBOSIS AND OCCLUSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21411871 ↗
• InjuryFeb 3, 2025Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE SMALL SILICONE PIECE WAS ALLEGEDLY DEFECTIVE UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE SMALL PIECE WAS UNABLE TO BE RETRIEVED FROM PATIENT. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21300825 ↗
• InjuryOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PORT ALLEGEDLY LEAKED UNDER THE SKIN. IT WAS FURTHER REPORTED THAT THE PATIENT'S CARD SAYS TO ACCESS IT WITH A ONE-INCH NEEDLE AND CLINICIANS BEGAN USING A ONE AND FIVE TENTHS-INCH NEEDLE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 20447923 ↗
• InjuryOct 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PORT WAS MOVING AROUND, AND CHEMO HAD ALLEGEDLY LEAKED UPON INFUSION. IT WAS FURTHER REPORTED THAT THE LEAKAGE HAD ALLEGEDLY OCCURRED AFTER DEACCESSED. FURTHERMORE, THE PATIENT ALLEGEDLY EXPERIENCED MEDICAL BURNS AND HAD ALLEGEDLY DEVELOPED WITH SEPSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Burning Sensation; Extravasation; Sepsis

  MAUDE report 20341693 ↗
• InjuryApr 17, 2024Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration

  IT WAS REPORTED THAT APPROXIMATELY SIX YEARS POST A PORT PLACEMENT, DURING A CHEST X-RAY, THE CATHETER WAS ALLEGEDLY FOUND TO BE FRACTURED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY BROKE IN HALF WHEN TRYING TO REMOVE THE PORT. ADDITIONALLY, THE CATHETER ALLEGEDLY MIGRATED TO THE FEMORAL ARTERY. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19128020 ↗
• MalfunctionOct 23, 2022Fluid/Blood Leak; Material Puncture/Hole; Naturally Worn; Fluid/Blood Leak; Material Puncture/Hole; Naturally Worn

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656509 ↗
• MalfunctionJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWENTY TWO DAYS POST PORT PLACEMENT PROCEDURE VIA RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY HAD BRUISE ON THE RIGHT SIDE OF THE NECK. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE BRUISE SITE. THE CURRENT STATUS OF THE PATIENT IS NOT KNOWN.

  Patient problems: Bruise/Contusion; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15127614 ↗
• MalfunctionJul 15, 2022Difficult to Insert; Difficult or Delayed Separation; Difficult to Insert; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CONNECTION BETWEEN THE PEEL AWAY AND DILATOR ALLEGEDLY LACK SMOOTH TRANSITION AREA. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AT THE NECK SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025636 ↗