Deltec 21-4477-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10610586039997), received between Sep 9, 2022 and Aug 24, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2023Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  IT WAS REPORTED THAT A PATIENT WAS SCHEDULED FOR PORT A CATH REMOVAL "DT" NON-FUNCTIONING PORT. AN X-RAY WAS TAKEN PRIOR TO INCISION AND A SEVERED PORT WAS NOTED. PARTIAL PORT REMOVED. THERE WAS CLINICIAN INJURY AND MEDICAL INTERVENTION. PATIENT REQUIRED ADDITIONAL CARE. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17615966 ↗
• MalfunctionSep 17, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CATHETER WAS TOO BIG TO ATTACH TO THE PORT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443222 ↗
• MalfunctionSep 10, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE DEVICE RECEIVED WAS A 6 FR PORT (THAT REQUIRES A 6 FR CATHETER TO ATTACH TO THE PORT); HOWEVER, THE CATHETER IN THE PACKAGE WAS SIZE 8 FR WHICH WAS TOO BIG TO ATTACH TO THE PORT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397568 ↗
• MalfunctionSep 10, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, WITH A PATIENT ON THE TABLE, THE SURGEON ATTEMPTED TO USE THE PORT BUT THE INTRODUCER WAS TOO LARGE TO FIT INTO THE LOCK ON THE PORT. TWO (2) TRAYS WERE ATTEMPTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397526 ↗
• MalfunctionSep 10, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO ATTACH THE CATHETER WITH THE CONNECTOR TO THE PORT HOUSING COUPLING DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397524 ↗
• MalfunctionSep 9, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, WITH A PATIENT ON THE TABLE, THE SURGEON ATTEMPTED TO USE THE PORT BUT THE INTRODUCER WAS TOO LARGE TO FIT INTO THE LOCK ON THE PORT. TWO (2) TRAYS WERE ATTEMPTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397451 ↗
• MalfunctionSep 9, 2022Flushing Problem; Flushing Problem

  IT WAS REPORTED THAT, UPON PRIMING, THE NURSE NOTICED THERE WAS SOME RESISTANCE WHEN FLUSHING THE PORT; JUST BEFORE CONNECTING TO CATHETER, THE NURSE COULD NOT ASPIRATE OR FLUSH THROUGH THE PORT SEPTUM. SEVERAL ATTEMPTS WERE MADE BUT NO SUCCESS. A NEW PRODUCT TRAY WAS OPENED AND USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397448 ↗

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;