Vital-Port G26438Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002264380), received between May 23, 2016 and Nov 10, 2017 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT WAS ACCESSED WITH A GRIPPED NEEDLE AND FLUSHED WITH SALINE, THE PATIENT FELT PAIN AND DEVELOPED REDNESS AROUND THE PORT POCKET SITE. THE ACCOUNT REPORTEDLY ATTRIBUTED THE PAIN AND SWELLING TO THE DELIVERY OF THE SALINE INFUSION TO AN UNINTENDED LOCATION IN THE PATIENT'S ANATOMY. THE PATIENT WAS SENT TO RADIOLOGY FOR IMAGING, AND X-RAYS SHOWED THAT THE PORT HAD DETACHED AND THE CATHETER WAS BROKEN APPROXIMATELY 3 CM FROM THE PROXIMAL/PORT CHAMBER END. THE INTERVENTIONAL RADIOLOGIST RETRIEVED THE BROKEN CATHETER USING A SNARE, AS IT WAS SITTING JUST ABOVE THE PATIENT'S RIGHT ATRIUM. THE PORT WAS REMOVED AND RETURNED FOR EVALUATION. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 7022077 ↗
• InjuryApr 7, 2017Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT HAD A VITAL-PORT ATTACHED SILICONE CATHETER WITH TITANIUM POWER INJECTABLE PORT IMPLANTED ON (B)(6) 2016 FOR CANCER TREATMENT. THE PATIENT IS A TENNIS PLAYER AND REPORTED DIFFICULTY IN FULLY EXTENDING HER ARM ABOVE HER HEAD TO SERVE AT TENNIS. THE PATIENT REPORTEDLY NOTICED IT EASIER TO MOVE HER ARM / SHOULDER THREE DAYS BEFORE THE PHYSICIAN NOTICED / DIAGNOSED THE CATHETER DAMAGE. THE PHYSICIAN OPINES POSSIBLE PINCH-OFF SYNDROME IN WHICH THE CATHETER IS COMPRESSED BETWEEN THE FIRST RIB AND THE CLAVICLE, CAUSING AN INTERMITTENT MECHANICAL OCCLUSION FOR BOTH INFUSION AND WITHDRAWAL. THE PORT WITH THE ATTACHED BROKEN CATHETER SEGMENT WAS REMOVED UNDER X-RAY GUIDANCE ON (B)(6) 2017. THE PROXIMAL END OF THE BROKEN CATHETER WAS OBSERVED REMAINING JUST BELOW THE LEVEL OF THE CLAVICLE DURING THE EXPLANT PROCEDURE. BEFORE THE PHYSICIAN WAS ABLE TO DETERMINE WHETHER OR NOT IT WAS FEASIBLE TO EXTRACT THIS VIA THE VENOUS TRACK THE NEXT IMAGE SHOWED THAT IT HAD THEN MIGRATED TO THE PATIENTS' ATRIUM. THE PATIENT WAS SENT FOR FRAGMENT REMOVAL FROM THE ATRIUM BY INTERVENTIONAL RADIOLOGY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 6472843 ↗
• InjuryMay 23, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE (B)(6) MALE PATIENT WITH PRE-EXISTING CONDITION OF CANCER HAD A VITAL PORT IMPLANTED ON (B)(6) 2016 AND IS BEING REMOVED ON (B)(6) 2016, DUE TO WHAT APPEARED TO BE SIGNS OF INFECTION OR A REACTION. THE DR SAID THE PATIENT WAS IMMUNOSUPPRESSED, THIN AND 3 ATTEMPTS HAD BEEN MADE IN GAINING ACCESS INTO THE PATIENTS RIGHT INTERNAL JUGULAR; WHICH COLLAPSED AND HAD DIFFICULTIES WITH THE WIRE. PATIENT HAD REDNESS AT AND ABOVE THE PORT POCKET AND WAS WARM TO TOUCH BUT NOT BELOW. REDNESS WAS ALSO NOTED AT THE INSERTION SITE. THE INCISION / WOUND SITE WAS CLEAN AND APPEARED TO BE FINE. PATIENT WAS GIVEN CEPHAZOLON ANTIBIOTICS AND THE PORT IS SCHEDULED TO BE REMOVED IN THE NEXT 24 HOURS AND WILL BE SENT TO PATHOLOGY FOR TESTING. DR ACCESSED TO FLUSH AND HEPLOCK THE PORT. PATIENT WENT HOME, IS YET TO RECEIVE TREATMENT.

  Patient problems: Inflammation

  MAUDE report 5672740 ↗