Vaccess 7380000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741027451), received between Nov 9, 2018 and Jun 18, 2026 — classified as 1 death, 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION, THROMBOSIS, AND SEPSIS, RESULTING IN A NEAR DEATH EXPERIENCE. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 25545309 ↗
• InjuryMar 18, 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24630430 ↗
• DeathSep 5, 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 PATIENT EVENTUALLY EXPIRED. HOWEVER CAUSE OF DEATH WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22976002 ↗
• 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 22712849 ↗
• InjuryMay 13, 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 22009992 ↗
• MalfunctionMar 21, 2025Difficult to Remove; Component Misassembled; Physical Resistance/Sticking; Difficult to Remove; Component Misassembled; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE PORT PLACEMENT PROCEDURE, THE GUIDEWIRE AND THE INTRODUCER NEEDLE ALLEGEDLY LOCKED TOGETHER UPON OPENING THE PACKAGE. IT WAS FURTHER REPORTED THAT NEEDLE AND GUIDEWIRE WAS ALLEGEDLY UNABLE TO BE SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661044 ↗
• InjuryJan 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 INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 21198143 ↗
• InjurySep 23, 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 PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20279271 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 19689065 ↗
• InjuryJul 8, 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. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19688064 ↗
• MalfunctionDec 8, 2021Fracture; Deformation Due to Compressive Stress; Material Protrusion/Extrusion; Fracture; Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A PORT IMPLANT PROCEDURE, THE GUIDEWIRE ALLEGEDLY HAD A PROBLEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958981 ↗
• MalfunctionSep 28, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PORT IMPLANT PROCEDURE, THE DEVICE HAD A SHEATH THAT DID NOT BREAK AWAY CORRECTLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538510 ↗
• MalfunctionApr 19, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 7380000 VACCESS CT LP PPORT 8F, INT TRAY W/SP EXPERIENCED HAVING FOREIGN MATERIAL PRESENT IN DEVICE. OF THIS EVENT, THE DEVICE WAS NOT USED ON THE PATIENT. THE FEMALE PATIENT DID NOT HAVE HER AGE OR WEIGHT PROVIDED. THE 7380000 VACCESS CT LP PPORT 8F, INT TRAY W/SP WAS RETURNED TO THE MANUFACTURER. UPON INVESTIGATION, THE REPORT WAS UNCONFIRMED BECAUSE THE PACKAGE HAD ALREADY BEEN OPENED AND IT WAS UNKNOWN WHETHER THE FOREIGN MATERIAL COULD HAVE BEEN A RESULT OF CLINICAL OR PACKAGING RETURN PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8533559 ↗
• InjuryDec 21, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIRTEEN DAYS AFTER PORT PLACEMENT, IMAGING DEMONSTRATED CATHETER SEPARATED FROM THE PORT AND MIGRATED TO THE RIGHT VENTRICLE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. ONE WEEK LATER THE PORT WAS REMOVED AND ANOTHER PORT WAS PLACED. THE PATIENT HANDLED THE REPLACEMENT PROCEDURE WELL AND WAS DISCHARGED THE SAME DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8189379 ↗
• MalfunctionNov 9, 2018Disconnection

  PT HAD A PORT-A-CATH PLACED. IT WAS FOUND TO HAVE BECOME DISCONNECTED VIA IMAGING. THIRTEEN DAYS LATER, THE CATHETER PORTION OF THE PAC WAS REMOVED AND ONE WEEK AFTER THAT, THE PORT ITSELF WAS REMOVED AND REPLACED WITH A NEW DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8054640 ↗