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Vital-Port G26511Recalls & reported problems

Cook Incorporated · Vital-Port Vascular Access System, Petite M.R.I. 6.5 Fr · Class 2 · Implant

All models of Vital-Port (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002265110), received between May 23, 2016 and Jan 19, 2018 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Separation” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Material Separation4
  • Fracture2

Patient problems

  • No Code Available5
  • Device Embedded In Tissue or Plaque1
  • Failure of Implant1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 19, 2018Fracture; Fracture

    IT WAS REPORTED THAT AN INFUSION PORT WAS IMPLANTED INTO THE PATIENT (B)(6) 2017. WHEN PATIENT CAME BACK TO THE HOSPITAL FOR TREATMENT, THE NURSING STAFF COULD NOT GET BLOOD RETURN UPON ACCESSING THE DEVICE. A SCAN WAS PERFORMED AND IT WAS DISCOVERED THAT THE PORT WAS CRACKED, CAUSING THE PATIENT TO UNDERGO AN ADDITIONAL PROCEDURE FOR THE SUCCESSFUL REINSERTION OF ANOTHER DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Patient problems: Failure of Implant

    MAUDE report 7205288 ↗
  • InjurySep 28, 2016Fracture; Fracture

    IT WAS REPORTED THAT A CATHETER; WHICH WAS INSERTED ON (B)(6) 2013 AT THE RIGHT INTERNAL JUGULAR (IJ) VEIN, FRACTURED DURING REMOVAL. THE PATIENT WAS TRANSFERRED BY AMBULANCE, FROM THE SURGERY CENTER TO ANOTHER HOSPITAL TO HAVE THE FRAGMENT REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

    MAUDE report 5983815 ↗
  • InjurySep 9, 2016Material Separation; Material Separation

    IT WAS REPORTED AFTER SEVERAL YEARS OF USE, THE PORT WAS REMOVED FROM THE PATIENT BECAUSE THE CATHETER FRACTURED AND BROKE OFF IN THE PATIENT. THIS EVENT ALLEGEDLY REQUIRED TRANSPORT BY AMBULANCE TO THE (B)(6) EMERGENCY ROOM, ALL PIECES WERE RETRIEVED AND THE CATHETER REMOVED. AS OF THE DATE OF THIS REPORT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Code Available

    MAUDE report 5938770 ↗
  • InjurySep 8, 2016Material Separation; Material Separation

    IT WAS REPORTED AFTER SEVERAL YEARS OF USE, THE PORT WAS REMOVED FROM THE PATIENT BECAUSE THE CATHETER FRACTURED AND BROKE OFF IN THE PATIENT. THIS EVENT ALLEGEDLY REQUIRED TRANSPORT BY AMBULANCE TO THE CHILDREN'S IR EMERGENCY ROOM, ALL PIECES WERE RETRIEVED AND THE CATHETER REMOVED. AS OF THE DATE OF THIS REPORT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Code Available

    MAUDE report 5936537 ↗
  • InjurySep 8, 2016Material Separation; Material Separation

    IT WAS REPORTED AFTER SEVERAL YEARS OF USE, THE PORT WAS REMOVED FROM THE PATIENT BECAUSE THE CATHETER FRACTURED AND BROKE OFF IN THE PATIENT. THIS EVENT ALLEGEDLY REQUIRED TRANSPORT BY AMBULANCE TO THE (B)(6) EMERGENCY ROOM. ALL PIECES WERE RETRIEVED AND THE CATHETER REMOVED. AS OF THE DATE OF THIS REPORT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Code Available

    MAUDE report 5935718 ↗
  • InjuryMay 23, 2016Material Separation; Material Separation

    THE PATIENT HAD A VITAL-PORT ATTACHED SILICONE CATHETER PLACED SOMETIME IN 2008 AND WAS REMOVED (B)(6) 2016. WHEN THE PORT WAS REMOVED, IT WAS SUBSEQUENTLY NOTED THAT THERE WAS A SLEEVE STILL LEFT WHICH REQUIRED A SEPARATE PROCEDURE TO REMOVE.

    Patient problems: No Code Available

    MAUDE report 5673841 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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Sources and updates

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