BioFlo Vortex CT80STBDVIRecalls & reported problems
Navilyst Medical, Inc. · SmartPort+ Standard Port with Endexo and Vortex Technology · Class 2 · Implant
All models of BioFlo Vortex (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787CT80STBDVI0), received between Nov 27, 2024 and Nov 27, 2024 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON OR ABOUT (B)(6) 2022, M.A. UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT+ PRODUCT, MODEL/CAT. NUMBER CT80STBDVI, LOT NUMBER 5733965. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMARTPORT+ STANDARD PORT WITH ENDEXO AND VORTEX TECHNOLOGY. THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), DO., AT (B)(6) HOSPITAL, IN (B)(6), KANSAS, FOR M.A.'S ECT. ON OR ABOUT (B)(6) 2022, A CT CHEST ABDOMEN W/CONTRAST PROCEDURE ADMINISTERED TO M.A. REVEALED THE PRESENCE OF THROMBUS IN M.A.'S BRACHIOCEPHALIC VEIN AND SUPERIOR VENA CAVA. THE THROMBUS AT ISSUE WAS DETERMINED TO BE ASSOCIATED WITH M.A.'S SMARTPORT. ON OR ABOUT (B)(6) 2022, M.A. WAS DIAGNOSED WITH "PARTIALLY OCCLUDING DEEP VENOUS THROMBOSIS RIGHT VEIN." AFTER FURTHER EVALUATION, M.A.'S MEDICAL TEAM DISCUSSED M.A.'S SMARTPORT REMOVAL, BUT IT POSTPONED THE REMOVAL OF THE DEFECTIVE CATHETER AT THAT TIME DUE TO THE CONCERN REGARDING BLEEDING WHILE M.A. WAS STILL ON THE PRESCRIBED ANTICOAGULANT THERAPY. ON (B)(6) 2023, M.A. RETURNED TO (B)(6) HOSPITAL IN (B)(6), FOR REMOVAL OF THE DEFECTIVE PORT-A-CATH, WHICH, UPON INFORMATION AND BELIEF, WAS REMOVED BY DR. (B)(6), DO. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED
Patient problems: Thrombosis/Thrombus
MAUDE report 20792082 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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