CELSITE 5430146Recalls & reported problems
B Braun Interventional Systems, Inc · CELSITE STL205F SM SET SIL 6,5F L IV USA · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046963594763), received between Feb 9, 2016 and Mar 23, 2016 — classified as 4 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Detachment Of Device Component1
Patient problems
- Foreign Body In Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2016Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2015: IMPLANTATION OF THE ACCESS PORT SYSTEM WITHOUT DIFFICULTIES. ON (B)(6) 2015: CATHETER DISCONNECTED FROM THE PORT.
Patient problems: Foreign Body In Patient
MAUDE report 5519426 ↗InjuryMar 23, 2016Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2015: IMPLANTATION OF THE ACCESS PORT SYSTEM WITHOUT DIFFICULTIES. ON (B)(6) 2015: CATHETER DISCONNECTED FROM THE PORT.
Patient problems: Foreign Body In Patient
MAUDE report 5519419 ↗InjuryMar 23, 2016Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2015: IMPLANTATION OF THE ACCESS PORT SYSTEM WITHOUT DIFFICULTIES. ON (B)(6) 2015: CATHETER DISCONNECTED FROM THE PORT.
Patient problems: Foreign Body In Patient
MAUDE report 5519184 ↗InjuryFeb 9, 2016Detachment Of Device Component; Detachment Of Device Component
DISCONNECTION OF THE CATHETER FROM THE ACCESS PORT, LESS THAN 2 MONTHS AFTER THE IMPLANTATION. REMOVAL OF THE CATHETER PERFORMED IN AN OTHER HOSPITAL.
Patient problems: Foreign Body In Patient
MAUDE report 5418549 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.