Deltec 21-8466-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586032837), received between Nov 1, 2022 and May 12, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 16, 2026.

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.

• MalfunctionMay 12, 2023Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  IT WAS REPORTED THAT THE DEVICE SEAL WAS DEFECTIVE AND MEDICATION WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918593 ↗
• MalfunctionNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE PERFORMING SURGERY THE PORT OF THE CATH WAS LEAKING. SURGEON HAD TO REMOVE AND REPLACE WITH NEW DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710252 ↗

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; 2.