CELSITERecalls & reported problems across all models
B Braun Interventional Systems, Inc · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CELSITE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 1
We found 7 models of CELSITE by B Braun Interventional Systems, Inc in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2016 and Feb 20, 2017 — classified as 17 injuries.
The most frequently reported specific device problem is “Detachment Of Device Component” (7 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
CELSITE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 21, 2025Open, Classified
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Z-2528-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported CELSITE problems
Device problems
- Detachment Of Device Component7
- Detachment of Device or Device Component3
- Fracture2
- Crack1
- Leak/Splash1
- Malposition of Device1
- Material Separation1
- Patient-Device Incompatibility1
Patient problems
- Foreign Body In Patient12
- No Information2
- Swelling2
- Pain1
- Skin Inflammation1
CELSITE models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CELSITE 5433742PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall2 reports
- CELSITE 5430146PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- CELSITE 5430425PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- CELSITE 5432460PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- CELSITE 5433750PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- CELSITE 5433556PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- CELSITE 5433823PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent CELSITE adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryDec 22, 2016Material Separation; Material Separation
PATIENT'S FAMILY CONTACTED B. BRAUN INTERVENTIONAL SYSTEMS TO REPORT THE FRAGMENT OF A PORT CATHETER SEVERING AND MIGRATING TO RIGHT ATRIUM, WHICH WAS SUCCESSFULLY RETRIEVED. PATIENT HAD PORT DUE TO DIAGNOSIS OF CANCER. SHORTLY AFTER DISCHARGE PATIENT FELT LIKE SOMETHING MOVED IN HER CHEST AND BEGAN EXPERIENCING CHEST PAINS. PATIENT RETURNED TO IMPLANTING HOSPITAL AND WAS TOLD THAT PAINS WERE ASSOCIATED WITH PORT "SETTLING IN" AND WAS SENT HOME. CHEST PAINS PERSISTED, PATIENT WENT TO SECOND HOSPITAL WHERE THEY PERFORMED CHEST X-RAY AND DETERMINED A PIECE OF THE PORT CATHETER BROKE OFF AND WENT INTO HEART. CATHETER SEGMENT WAS RETRIEVED PERCUTANEOUSLY THROUGH JUGULAR VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 6197787 ↗InjuryOct 5, 2016Detachment Of Device Component; Detachment Of Device Component
ON (B)(6) 2016: IMPLANTATION OF AN ACCESS PORT VIA THE RIGHT SUBCLAVIAN VEIN. THE CORRECT CATHETER CONNECTION WAS CONFIRMED. ON (B)(6) 2016: DURING THE SECOND CHEMOTHERAPY ADMINISTRATION, DISCONNECTION FO THE CATHETER IS NOTED. THE CATHETER WAS REMOVED BY FEMORAL APPROACH DUE TO ITS MIGRATION IN THE VENA CAVA. ON (B)(6) 2016: EXPLANTATION OF THE ACCESS PORT AND PLACEMENT OF A SECOND ONE. REMARK: NO PROBLEM DURING THE ADMINISTRATION OF THE FIRST CHEMOTHERAPY TREATMENT.
Patient problems: Foreign Body In Patient
MAUDE report 5999949 ↗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 ↗InjuryAug 9, 2016Crack; Crack
ON (B)(6) 2014, IMPLANTATION OF AN ACCESS PORT VIA RIGHT SUBCLAVIAN APPROACH.ON (B)(6) 2016, DURING THE CHECKING BEFORE THE CHEMOTHERAPY INJECTION, IT WAS DETECTED PAIN AT THE RIGHT SHOULDER AND OEDEMA AT THE UPPER PART OF THE ACCESS PORT.ON (B)(6) 2016, THE PATIENT WAS TAKEN TO OPERATING THEATER FOR ACCESS PORT REMOVAL BECAUSE OF DYSFUNCTION SUSPICIAON. THE REMOVED CATHETER DISPLAYS A CRACK ON ITS THRID PROXIMAL PART, AT ABOUT 5 MM FROM THE CONNECTION. NO DEFECT IS APPARENT ON THE REST OF THE CATHETER.
Patient problems: Pain; Swelling
MAUDE report 5856998 ↗InjuryJul 4, 2016Leak/Splash; Leak/Splash
LEAKAGE OF CHEMOTHERAPY DRUG AROUND THE ACCESS PORT. SURGERY IN EMERGENCY TO REMOVE THE ACCESS PORT SYSTEM.
Patient problems: No Information
MAUDE report 5767951 ↗InjuryJun 28, 2016Detachment Of Device Component; Detachment Of Device Component
"THE CATHETER SEPARATED FROM THE APPLICATION DEVICE INTO THE PATIENT CAUSING THE LOCAL BULGE. THE PATIENT DIED BECAUSE HE WAS BEARER OF A DISEASE (CANCER) AND WAS IN THE TERMINAL PHASE OF THE DISEASE. THEREFORE THE FAMILY HASN'T AUTHORIZED THE REMOVAL OF THE DEVICE. EMPHASIZING THAT THE PATIENT DIDN'T CAME TO DEATH DUE TO WHAT HAPPENED TO THE PORT".
Patient problems: Swelling
MAUDE report 5754433 ↗InjuryJun 28, 2016Malposition of Device; Malposition of Device
ACCESS PORT SYSTEM CATHETER WAS INSERTED THROUGH SUBCLAVIAN VEIN USING OPEN SURGERY TECHNIQUE ON (B)(6) 2016. WHEN THE DOCTOR TRIED TO ACCESS THE PORT USING PORT NEEDLES AFTER 4 HOURS, THE FLUID TENDED TO LEAK OUT . THEY PERFORMED CHEST X-RAY AND FOUND OUT IT WAS DUE TO CATHETER TIP DISPLACEMENT TO THE NECK. DOCTOR DECIDED TO READJUST THE CATHETER TIP POSITION ON (B)(6) 2016. HOWEVER ON (B)(6) 2016, THE CATHETER TIP DISPLACED AGAIN FROM SVC TO PATIENT'S NECK. DOCTOR DECIDED TO REMOVE THE BABYPORT AND IMPLANT A NEW CELSITE ST 305 ACCESS PORT.
Patient problems: No Information
MAUDE report 5754432 ↗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 ↗InjuryMay 24, 2016Patient-Device Incompatibility; Patient-Device Incompatibility
ACCESS PORT IMPLANTED ON (B)(6) 2015. AFTER 6 TREATMENTS OF TAOTERE (100MG/M2), APPARITION OF A SKIN REDNESS ON THE WHOLE LENGTH OF THE TUNNELED CATHETER. BLOOD CULTURE: NEGATIVE. NO INFLAMMATORY REACTION ABOVE THE ACCESS PORT HOUSING.
Patient problems: Skin Inflammation
MAUDE report 5675146 ↗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 ↗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 ↗
Other B Braun Interventional Systems, Inc products
All B Braun Interventional Systems, Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page