Deltec 21-3368-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586033018), received between May 3, 2017 and Jun 4, 2022 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJun 4, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE GRIPPER WAS NOT RESISTING TO PRESSURE DURING INJECTION UNDER PRESSURE IN CT AND MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599417 ↗
• MalfunctionJun 2, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE GRIPPER WAS NOT RESISTING TO PRESSURE DURING INJECTION UNDER PRESSURE IN CT AND MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578384 ↗
• InjuryMay 3, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A DELTEC® GRIPPER PLUS® POWER P.A.C. SAFETY HUBER NEEDLE WAS LEAKING. PATIENT INFORMED THE RN THAT HE FELT WETNESS AROUND HIS PORT SITE. ON INSPECTION, THE NURSE NOTICED THERE WAS A LEAK AT THE JUNCTION POINT OF THE MEDICAL NEEDLE AND THE PLASTIC LINE. PORT NEEDLE WAS REMOVED, AND PATIENT RE-ACCESSED. REMNANTS OF BLOOD WERE VISIBLE AT THE POINT OF LEAKAGE. THE PATIENT WAS EXPOSED TO CHEMOTHERAPY ON HIS SKIN. THE SKIN WAS WASHED AS PER PROTOCOL AND THE PATIENT WAS GOING TO FOLLOW-UP WITH HIS PHYSICIAN. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Chemical Exposure

  MAUDE report 6541776 ↗

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.