Deltec 21-3276-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586029936), received between Sep 4, 2024 and Nov 4, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT SAFETY DEVICE DID NOT ENGAGE WHEN THEY WERE ATTEMPTING TO ACCESS A CHEST PORT USING THE CENTURION KIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464869 ↗
• MalfunctionNov 4, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE Y-SITE CONNECTOR BROKE ON A PATIENT'S HUBER NEEDLE, CAUSING FLUID AND BLOOD TO LEAK OUT. THIS RESULTED IN THE PATIENT NEEDING TO BE RE-ASSESSED. THIS WAS THE SECOND INCIDENT THAT OCCURRED IN THE RECENT WEEKS AND IS A MAJOR PATIENT AND OPERATIONAL CONCERN. THERE WAS PATIENT INVOLVEMENT, BUT UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599588 ↗
• MalfunctionSep 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE REMOVING THE DRESSING THE TOP PART OF THE PORT NEEDLE CAME OFF. THE NURSE WAS ABLE TO REMOVE THE NEEDLE FROM CHEST WALL WITH NO ISSUES OR CONCERNS. NO PATIENT HARM OTHER THAN IT WAS MORE PAINFUL THAN NORMAL TO TAKE THE NEEDLE OUT SINCE THERE WAS NOTHING TO GRAB TO REMOVE THE NEEDLE FROM HIS CHEST. THERE WAS DELAY IN THERAPY AND NO ADVERSE EVENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20139844 ↗
• MalfunctionSep 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE REMOVING THE DRESSING THE TOP PART OF THE PORT NEEDLE CAME OFF. THE NURSE WAS ABLE TO REMOVE THE NEEDLE FROM CHEST WALL WITH NO ISSUES OR CONCERNS. NO PATIENT HARM OTHER THAN IT WAS MORE PAINFUL THAN NORMAL TO TAKE THE NEEDLE OUT SINCE THERE WAS NOTHING TO GRAB TO REMOVE THE NEEDLE FROM HIS CHEST. THERE WAS DELAY IN THERAPY AND NO ADVERSE EVENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20139135 ↗