Vaccess 7460000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741027468), received between Jun 16, 2021 and Sep 25, 2026 — classified as 1 death, 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (3 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 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 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 50894484 ↗
• InjuryJun 15, 2026Fracture; Expulsion

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT ALLEGEDLY HAD CATHETER FRACTURE. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED EROSION OR WOUND COMPLICATIONS AT PORT BODY SITE. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 25498412 ↗
• InjuryJan 8, 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 UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 24000871 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23988265 ↗
• DeathDec 26, 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 AN UNSPECIFIED INFECTION AND THROMBOSIS. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT PROVIDED.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23894944 ↗
• InjuryNov 26, 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 INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23655596 ↗
• InjurySep 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PORT PLACEMENT OF VACCESS CT POWER PORT ON THE MONTH OF (B)(6) 2022. LATER THAT POST PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED BURNING SENSATION AND PAIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain; Skin Burning Sensation

  MAUDE report 23143481 ↗
• InjurySep 22, 2025Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fracture; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2021, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT. ON (B)(6) 2025, IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE DAMAGED AND TORN. ON (B)(6) 2025, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Neck Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23107731 ↗
• InjurySep 22, 2025Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT. ON (B)(6) 2025, THE DEVICE WAS PLACED. POST A PORT PLACEMENT PROCEDURE ON (B)(6) 2025, THE CATHETER WAS ALLEGEDLY FOUND DAMAGED AND RIPPED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND LEAKING AND EXTRAVASATION WAS FOUND. THE DEVICE WAS REMOVED ON (B)(6) 2025. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23107727 ↗
• InjurySep 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 22963678 ↗
• InjurySep 3, 2025Suction Problem; Migration; Suction Problem; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT ABOUT SOMETIME LATER POST A PORT PLACEMENT PROCEDURE, THE PORT WAS MIGRATED. IT WAS FURTHER REPORTED THAT PORT DEVELOPED WITH SUCTION ISSUE. IT WAS FURTHER REPORTED THAT PATIENT DEVELOPED WITH SHORTNESS OF BREATH, PALPITATIONS AND PAIN AROUND THE PORT SITE. REPORTEDLY, THE PORT WAS REMOVED, AND NEW PORT HAS BEEN IMPLANTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyspnea; Pain; Unspecified Respiratory Problem

  MAUDE report 22949716 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Tipped Over; Device Appears to Trigger Rejection; Device Tipped Over

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO MONTHS TWO WEEKS AND THREE DAYS LATER PORT PLACEMENT PROCEDURE, THE PORT ROTATED AND FIBRIN SHEATH FORMATION AROUND THE TIP OF THE CATHETER. REPORTEDLY, THE PORT WAS REMOVED, AND NEW PORT HAS BEEN IMPLANTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 22901610 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY TEN MONTHS FOUR WEEKS PORT PLACEMENT PROCEDURE VIA RIGHT INTERNAL JUGULAR VEIN, PATIENT WAS DIAGNOSED WITH METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 22768763 ↗
• InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH BACK PAIN AND THROMBUS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 22574223 ↗
• InjuryJul 22, 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 AND DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22563432 ↗
• InjuryJun 12, 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 UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22192000 ↗
• InjuryJun 10, 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22173301 ↗
• InjuryJan 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 ALLEGEDLY DEVELOPED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21262776 ↗
• InjuryJan 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 ALLEGEDLY DEVELOPED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21262590 ↗
• InjuryJan 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 ALLEGEDLY DEVELOPED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21262352 ↗
• InjurySep 16, 2024Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD ISSUES IN BLOOD RETURN. IT WAS FURTHER REPORTED THAT THE PATIENT HAD BLOOD CLOTS IN THE RIGHT JUGULAR VEIN. REPORTEDLY, THE HEALTH CARE PROFESSIONAL HAD TO TAKE THE PORT OUT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20225846 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Cellulitis; Sepsis; Unspecified Infection

  MAUDE report 19094424 ↗
• MalfunctionDec 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PORT ALLEGEDLY HAD A LEAK WHEN USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361585 ↗
• MalfunctionSep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED NUMBNESS/TINGLING TO THE HAND. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN TO THE VEIN NEAR THE THUMB. HOWEVER, THERE IS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE MEDICAL INTERVENTION PERFORMED OR MEDICATION PRESCRIBED FOR TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746558 ↗
• MalfunctionJun 16, 2021Device Tipped Over; Loosening of Implant Not Related to Bone-Ingrowth; Device Tipped Over; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT SOME TIME POST PORT DEVICE PLACEMENT, THE PATIENT EXPERIENCED A FLUTTERING ON HER RIGHT BREAST. IT WAS FURTHER REPORTED THAT THE PORT ALLEGEDLY HAD TO BE FILLIPED AT TIMES IN ORDER TO ACCESS IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006444 ↗