DIGNITY® MRDP50AXSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884908149753), received between Dec 2, 2020 and Oct 31, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (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. Jan 13, 2021Open, Classified

   The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.

   Z-1184-2021 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Leak/Splash; Leak/Splash

  PATIENT HAD A 5FR PORT WHICH HAD BEEN IMPLANTED ON (B)(6) 2024 AND HAD BEEN IN PLACE FOR 482 DAYS FOR TREATMENT. ON (B)(6) 2025, PORT WAS TO BE ACCESSED AND IT WAS OBSERVED BY NUMEROUS RNS THAT THERE APPEARED TO BE EXTRAVASATION OF FLUIDS AND THE SITE WAS SWOLLEN. A DYE STUDY WAS ORDERED AND PERFORMED ON (B)(6) AT 1236. DURING THE DYE STUDY, ACCESS WAS ACHIEVED VIA HUBER NEEDLE BUT NO BLOOD RETURN WAS NOTED, CONTRAST WAS INJECTED AND IT WAS DEMONSTRATED THAT THE CONTRAST WAS FILLING THE PORT BODY AND SURROUNDING POCKET BUT NOT ENTERING THE CATHETER. PATIENT WAS BROUGHT TO SEDATION TO HAVE PORT REMOVED ON 10/10 IN THE AFTERNOON AND PORT WAS TO BE REPLACED. DURING REMOVAL, UPON EXCISION OF THE BODY OF THE PORT FROM THE PATIENT, IT WAS OBSERVED THAT THERE IS A PIN HOLE IN THE BACK OF THE PORT BODY, THROUGH THE PRINTED T ON THE BACK. PORT WAS REPLACED WITH SAME SIZE AND EXCISED IMPLANT WAS SAVED FOR DEFECT REPORTING.

  Patient problems: Swelling/ Edema

  MAUDE report 23434973 ↗
• MalfunctionOct 23, 2025Material Puncture/Hole; Material Puncture/Hole

  PATIENT SEEN FOR A FLOW STUDY OF HER PORT. IR PA (B)(6) PERFORMED STUDY THAT SHOWED LEAKING OF THE CONTRAST FROM POSTERIOR PART OF THE PORT RESERVOIR. PATIENT TO OPERATING ROOM ON (B)(6) FOR PORT REMOVAL AND NEW PORT PLACEMENT. VISIBLE AND PALPABLE "HOLE" IN HARD PLASTIC BACKING OF PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23371833 ↗
• MalfunctionDec 2, 2020Component Incompatible; Component Incompatible

  THE DEVICE WAS BEING USED FOR AN ARM INSERTION. AFTER GAINING ACCESS, POSITIONING THE CATHETER, AND REMOVING THE PEEL-AWAY SHEATH, IT WAS DISCOVERED THAT THE PORT STEM WAS NOT COMPATIBLE WITH THE F SIZE OF THE CATHETER.

  Patient problems: Thrombosis

  MAUDE report 10934429 ↗