Smart Port CT H787CT66LTPDNF0Recalls & reported problems
Angiodynamics, Inc. · Smart Port CT Low Profile Titanium Port System with Attachable 6.6F x 55cm Polyurethane Catheter and 7F Introducer Kit (Non-Filled Suture Holes) · Class 2 · Implant
All models of Smart Port CT (36)
Data updated Oct 18, 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 15051684018081), received between Jun 5, 2026 and Jun 5, 2026 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Medical device site infection1
- Pocket Erosion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL H787CTLTPDNF0, LOT NUMBER 5751584. THE SMARTPORT WAS IMPLANTED ON THE RIGHT SIDE OF HER CHEST BY DR. (B)(6) MD., (B)(6). IN OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO THE (B)(6) ONCOLOGY AND WAS FOUND TO HAVE THE PORT SHOWING THROUGH HER SKIN AND IT WAS INFECTED. HER MEDICAL TEAM DETERMINED THAT SHE REQUIRED EMERGENCY ADMITTANCE TO THE HOSPITAL AS THE SMARTPORT INFECTED AND REQUIRED IMMEDIATE REMOVAL FROM THE PLAINTIFF'S BODY. THE DEFECTIVE PORT WAS SUBSEQUENTLY REMOVED ON (B)(6) 2023, AND REPLACED ON (B)(6) 2023, TO ALLOW PLAINTIFF TO CONTINUE CHEMOTHERAPY TREATMENT.
Patient problems: Medical device site infection; Pocket Erosion
MAUDE report 25415196 ↗
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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