CELSITE 5432460Recalls & reported problems
B Braun Interventional Systems, Inc · CELSITE ST301H ST SET PUR 8,5F IV USA · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963594893), received between Apr 22, 2016 and Feb 20, 2017 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment Of 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 Component3
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2017Detachment Of Device Component; Detachment Of Device Component
ON (B)(6) 2015 PORT IMPLANTATION ON THE LEFT CEPHALIC VEIN; ON (B)(6) 2015 DISCOVERY OF THE CATHETER DISCONNECTION FROM PORT; ON (B)(6) 2015 PORT EXPLANTATION; ON (B)(6) 2015 PORT IMPLANTATION IN RIGHT SUBCLAVIAN VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 6343018 ↗InjuryApr 22, 2016Detachment Of Device Component; Detachment Of Device Component
ON (B)(6) 2016 PORT IMPLANTATION ON THE CEPHALIC VEIN. ON (B)(6) 2016 DISCOVERY OF THE CATHETER DISCONNECTION FROM PORT. ON (B)(6) 2016 PORT EXPLANTATION.
Patient problems: Foreign Body In Patient
MAUDE report 5597192 ↗InjuryApr 22, 2016Detachment Of Device Component; Detachment Of Device Component
ON (B)(6) 2016 PORT IMPLANTATION ON THE LEFT CEPHALIC VEIN. ON (B)(6) 2016 DISCOVERY OF THE CATHETER DISCONNECTION FROM PORT. ON (B)(6) 2016 PORT EXPLANTATION.
Patient problems: Foreign Body In Patient
MAUDE report 5597145 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
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- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
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- 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.