CELSITE 5433750Recalls & reported problems
B Braun Interventional Systems, Inc · CELSITE ST305 SM SET SIL 6,5F IV USA · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 04046963594954), received between Feb 1, 2016 and Sep 13, 2016 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (2 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
- Fracture2
- Detachment Of Device Component1
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.
InjurySep 13, 2016Detachment Of Device Component; Detachment Of Device Component
DISCONNECTION AND MIGRATION OF THE CATHETER, DETECTED BEFORE CHEMOTHERAPY TREATMENT.
Patient problems: Foreign Body In Patient
MAUDE report 5945238 ↗InjuryJun 21, 2016Fracture; Fracture
IMPLANTATION OF THE ACCESS PORT ON (B)(6) 2015. ON (B)(6) 2016, REMOVAL OF THE ACCESS PORT DUE TO DETECTION OF A LEAKAGE. REMOVAL WITHOUT RESISTANCE HOWEVER ONE PART OF THE CATHETER IS MISSING. PATIENT TRANSFERRED IN ANOTHER HOSPITAL IN ORDER TO REMOVE THE DISTAL PART OF THE CATHETER BY INTERVENTIONAL RADIOLOGY.
Patient problems: Foreign Body In Patient
MAUDE report 5738583 ↗InjuryFeb 1, 2016Fracture; Fracture
"BROKEN CATHETER AFTER 4.5 YEARS. A CHILD HAS AN ACCESS PORT IMPLANTED NEXT TO THE HEART. THE BROKEN TUBE DISAPPEARED INTO THE HEART."
Patient problems: Foreign Body In Patient
MAUDE report 5401700 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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