Vital-Port G26449Recalls & reported problems
Cook Incorporated · Vital-Port Vascular Access System, Standard 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002264496), received between Feb 15, 2017 and Feb 15, 2017 — classified as 1 malfunction.
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
Device problems
- Material Separation1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2017Material Separation; Material Separation
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT HAD A VITAL-PORT VASCULAR ACCESS SYSTEM IMPLANTED FOR AN UNSPECIFIED INDICATION. THE SPECIFIC SITE AND ROUTE OF IMPLANTATION WAS NOT PROVIDED. THE DEVICE ALLEGEDLY BROKE AT AN UNSPECIFIED TIME FOLLOWING IMPLANTATION. THE SIGNS, SYMPTOMS, CIRCUMSTANCES AND CONDITIONS THAT PROMPTED A RETURN OF THE PATIENT AND INDICATED A BREAK OF THE DEVICE WERE NOT PROVIDED. X-RAYS WERE TAKEN AND CONFIRMED THAT DEVICE BROKE / SEPARATED. THE PATIENT RETURNED TO THE HOSPITAL FOR EXPLANT OF THE PORT AND REMOVAL OF THE CATHETER FROM THE RIGHT ATRIUM. ONE OF THE PEDIATRIC PHYSICIANS WITH KNOWLEDGE OF THE EVENT PROVIDED ADDITIONAL DETAILS STATING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL UNDER THE PEDIATRIC CARDIOLOGY AND ADULT INTERVENTIONAL RADIOLOGY SERVICES. "THE TUBING AND THE DEVICE ITSELF WERE COMPLETELY SEPARATED AND THE TUBING HAD MIGRATED INTO THE PATIENT SO THAT THE TIP LAY IN THE RIGHT VENTRICLE. THIS POSED A RISK FOR CARDIAC ARRHYTHMIA AS WELL AS PULMONARY EMBOLUS." "THE PATIENT WAS NOT SYMPTOMATIC BUT WAS AT RISK OF A LIFE THREATENING COMPLICATION SHOULD AN ARRHYTHMIA OR EMBOLUS OCCUR. " THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE CATHET
Patient problems: No Code Available
MAUDE report 6332169 ↗
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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