Vaccess 7360001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741027444), received between Oct 18, 2019 and Sep 1, 2026 — classified as 1 death, 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathSep 1, 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 50545784 ↗
• InjuryJan 30, 2026Migration

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE VACCESS CT LOW PROFILE PORT. AFTER SOME TIME, THE PATIENT EXPERIENCED PAIN IN HIS LEFT ARM WHERE THE PORT WAS LOCATED. IT WAS FURTHER REPORTED THAT THE PATIENT FELT A BUMPING SENSATION, AS IF THE CATHETER WAS MOVING OVER A BONE OR LIGAMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 24219234 ↗
• InjuryNov 14, 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 23551412 ↗
• MalfunctionSep 16, 2025Material Puncture/Hole; Device Damaged Prior to Use; Material Puncture/Hole; Device Damaged Prior to Use

  ON (B)(6) 2025, A PATIENT UNDERWENT A PLACEMENT PROCEDURE USING VACCESS CT LOW-PROFILE PORT. PRIOR TO THE PROCEDURE UPON OPENING THE VACCESS CT LOW-PROFILE PORT KIT, THE CUSTOMER OBSERVED TWO PUNCTURES/GASHES ON THE SILICONE SEPTUM OF THE PORT. THE DAMAGE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060953 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 21948803 ↗
• MalfunctionSep 25, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY TOO TIGHTLY COILED. IT WAS FURTHER REPORTED THAT THE COILED CATHETER ALLEGEDLY LEAVES CURVES WHICH MOST DECIDEDLY DO NOT GO AWAY EVEN WHEN MATERIAL WARMS UP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17805966 ↗
• MalfunctionAug 18, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TWO YEARS EIGHT MONTHS AND EIGHT DAYS POST PORT PLACEMENT, A HOLE WAS ALLEGEDLY IDENTIFIED IN THE CATHETER UPON BEING EXPLANTED. IT WAS FURTHER REPORTED THAT THE PORT ALLEGEDLY LEAKED. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570188 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE PATIENT ALLEGEDLY EXPERIENCED SWELLING IN THE RIGHT ARM. THE DEVICE WAS PLANNED TO BE REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 12688996 ↗
• MalfunctionFeb 18, 2021Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT POST PORT PLACEMENT, IT WAS ALLEGEDLY UNABLE TO FLUSH THE PORT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341609 ↗
• MalfunctionFeb 12, 2021Fracture; Stretched; Deformation Due to Compressive Stress; Fracture; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT, THE WIRE ALLEGEDLY UNRAVELED WHILE INSERTION. THEREFORE, THE NEEDLE AND WIRE WAS PULLED OUT AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320355 ↗
• MalfunctionApr 15, 2020Obstruction of Flow; Obstruction of Flow

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7360001 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY EXPERIENCED OBSTRUCTION OF FLOW. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965534 ↗
• MalfunctionOct 18, 2019Material Frayed; Material Frayed

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7360001 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED MATERIAL FRAYED. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS DID NOT INVOLVE A PATIENT. PATIENT AGE, GENDER, AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9211266 ↗