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
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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