Deltec 21-4476-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586039980), received between Dec 9, 2024 and Dec 9, 2024 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K072657); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Degraded; Degraded

  IT WAS REPORTED THAT SEVERAL DAYS AFTER THE PATIENT'S PORT WAS EXPLANTED, THE DEVICE WAS SENT TO THE PATHOLOGY DEPT. FOR TESTING AND WAS DETERMINED TO BE THE SOURCE OF THE PATIENT'S PERSISTENT INFECTION. CONCERN WAS EXPRESSED THAT THE MATERIALS USED IN THE MANUFACTURING OF THE CATHETER CONTAINED TOO HIGH OF A CONCENTRATION OF BARIUM SULFATE PARTICLES FOR POLYMER FORMULATION, PROMOTING MICROFRACTURES AND WEAKENING AREAS THAT LED TO THE COLLECTION AND PROLIFERATION OF BLOOD PRODUCTS, THEREBY DRASTICALLY INCREASING THE RISK OF BIOFILM, INFECTION, AND SEPSIS. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 20878637 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072657. One submission often covers many models, so check the product and lot details in each record.

• Z-2499-2020 · Jun 11, 2020 · Terminated
  PORT-A-CATH II POWER P.A.C. Low Profile" system.
• Z-0190-2020 · Jul 8, 2019 · Terminated
  GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA;