Deltec 21-4425-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586032646), received between Apr 27, 2022 and Oct 2, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024Component Misassembled; Component Misassembled

  IT WAS STATED THAT THE CATHETER WAS CONNECTED TO THE CHAMBER WITH THE FRONT PART (TIP). AS A RESULT, IT WAS NOT USABLE. THE CATHETER WAS ALREADY CONNECTED TO THE WRONG END IN THE PACKAGING OR DURING PRODUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352553 ↗
• InjuryApr 28, 2022Crack; Crack

  IT WAS REPORTED THAT A PATIENT WAS INJURED. CATHETER TUBING APPEARS TO BE CRACKED.

  Patient problems: Pain

  MAUDE report 14231062 ↗
• InjuryApr 27, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WAS INJURED - EXTRAVASATION EVENT RELATING TO PORT-A-CATH. PORT-A-CATH REMOVED, SMALL HOLE HALFWAY ALONG THE LENGTH OF THE PORTACATH LINE.

  Patient problems: Pneumonia

  MAUDE report 14219506 ↗

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;