Deltec 21-3466-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586033056), received between Oct 24, 2019 and Sep 10, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Flushing 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.

• MalfunctionSep 10, 2022Flushing Problem; Material Frayed; Flushing Problem; Material Frayed

  IT WAS REPORTED THAT WHEN THE NURSE ATTEMPTED TO ACCESS THE PATIENT'S PORT, THE PATIENT GRIMACED. THE NEEDLE WAS UNABLE TO BE FLUSHED OR DRAW AND WHEN THE NEEDLE WAS WITHDRAWN A SMALL DISTANCE, IT WOULD FLUSH BUT NOT DRAW. IT WAS REPORTED THAT THE NEEDLE FELT ROUGH INSTEAD OF SMOOTH; AND FELT LIKE THERE WAS A BURR ON THE EDGE. A NEW NEEDLE WAS USED AND THE PORT WAS ACCESSED WITHOUT ANY INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397565 ↗
• InjuryOct 24, 2019Retraction Problem; Retraction Problem

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING FLUSHING THE PORT AND REMOVAL OF THE A SMITHS MEDICAL DELTEC® GRIPPER PLUS® NEEDLE, THE SAFETY FAILED TO DEPLOY. SUBSEQUENTLY, THE CLINICIAN RECEIVED A NEEDLE STICK TO THE THUMB. THE NEEDLE STICK PROTOCOL WAS PERFORMED ALONG WITH A TETANUS SHOT ADMINISTRATION. THERE WERE NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9235429 ↗

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.