Deltec 21-3362-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586032967), received between Sep 9, 2022 and Sep 9, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (2 reports).

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.

• MalfunctionSep 9, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT, WHEN THEY INJECTED THROUGH THE POWER PORT TUBING THE PRESSURE WOULD RISE UP; BUT AT 300 PSI, IT WOULD BE CONSIDERED PRESSURE LIMITING AND THE INJECTOR ITSELF WILL SUDDENLY DROP THE RATE - NOT GRADUALLY BUT QUICKLY, AT 1 OR 2 ML PER SECOND, WHICH CAN CAUSE A NONOPTIMAL ENHANCEMENT OF THE CONTRAST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397428 ↗
• MalfunctionSep 9, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT WHEN THE USER INJECTS THROUGH THE POWER PORT TUBING, THE PRESSURE WILL RISE UP. HOWEVER, AT 300 PSI, IT WAS CONSIDERED PRESSURE-LIMITING AND THE INJECTOR ITSELF WILL SUDDENLY DROP THE RATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397424 ↗

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.