Vital-Port G26434Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002264342), received between May 24, 2016 and Dec 22, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2016Material Separation; Material Separation

  PORT HAS BEEN IN PLACE FOR JUST UNDER 1 MONTH. PATIENT RETURNED FOR SECOND CHEMO TREATMENT AND STAFF COULD NOT ASPIRATE BLOOD. PATIENT SENT TO X-RAY AND FOUND THAT PORT CATHETER HAD SEPARATED/BROKEN TORN OFF JUST BELOW THE COLLAR, ACTUALLY ON THE CATHETER AND THE REMAINING CATHETER HAD TRAVELED INTO THE BLOOD SVC AND REQUIRED A FURTHER PROCEDURE IN THE HYBRID LAB TO REMOVE THE EMBOLIZED SILICONE PORT CATHETER. THIS WAS DONE VIA THE GROIN AS AN EMERGENCY PROCEDURE. PATIENT MISSED THEIR CHEMO DOSE AND HAD TO HAVE A LENGTHY ENDOVASCULAR RETRIEVAL PROCEDURE. THE DEVICE REMAINED INSIDE THE PATIENT BODY. THE PATIENT REQUIRED ANOTHER CVAD DEVICE TO BE PLACED SO PATIENT COULD GET TREATMENT DUE TO THIS OCCURRENCE. THE COMPLAINANT INFORMED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. HOWEVER, THE COMPLAINANT DOES NOT KNOW HOW THE CATHETER BROKE OFF INSIDE THE PATIENT. ONLY THAT IT DID.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6200365 ↗
• InjuryMay 24, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS PROVIDED THAT THE VITAL-PORT WAS INSERTED ON (B)(6) 2016 AND REMOVED ON THE (B)(6) 2016 FROM THE (B)(6) FEMALE PATIENT WITH PRE-EXISTING CONDITION OF CANCER, DUE TO WHAT APPEARED TO BE SIGNS OF INFECTION OR A REACTION. THE PHYSICIAN STATED THAT THE PATIENT WAS NOT IMMUNOSUPPRESSED NOR HAD ALLERGIES. HOWEVER, THE PATIENT HAD REDNESS AT THE PORT POCKET, THE TUNNELED TRACT AND ALSO AT THE INSERTION SITE. THE WOUND PORT POCKET SITE ALSO DISPLAYED SIGNS OF WEEPING; THEREFORE, THE PATIENT COULD NOT RECEIVE HER CHEMO TREATMENT. THE PORT WAS REMOVED AND SENT TO THE FACILITY'S PATHOLOGY DEPARTMENT. FOR CULTURE. NO UNEXPECTED PART OF THE DEVICE REMAINED INSIDE THE PATIENT; HOWEVER, THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE; PATIENT WAS GIVEN CEPHAZOLON ANTIBIOTICS AND PORT IS BEING REMOVED WITH THE NEXT 24 HOURS. THE INITIAL REPORTER DID NOT SPECIFY ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT, HOWEVER THE DESCRIPTION OF EVENT STATES: PATIENT HAD REDNESS AT AND ABOVE THE PORT POCKET AND WAS WARM TO TOUCH BUT NOT BELOW, THERE WAS ALSO REDNESS AT THE INSERTION SITE.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 5676835 ↗