CELSITE 5433742Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963594947), received between Jun 28, 2016 and Aug 9, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Crack” (1 report).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗