Deltec 21-2966-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10610586027741), received between May 23, 2016 and Jun 25, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K021999); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A LEAKAGE AT THE COLLAR PORT NEAR THE ACCESS NEEDLE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327545 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING IV PUSH MEDICATION ADMINISTRATION WITH FLUIDS RUNNING, FLUID OR MEDICATION LEAKED FROM THE COLLAR OF THE PORT CLOSEST TO THE ACCESS NEEDLE. THIS HAD BEEN USED TWICE. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171063 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING IV PUSH MEDICATION ADMINISTRATION WITH FLUIDS RUNNING, FLUID OR MEDICATION LEAKED FROM THE COLLAR OF THE PORT CLOSEST TO THE ACCESS NEEDLE. THIS HAD BEEN USED TWICE. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158327 ↗
• MalfunctionApr 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE NEEDLE LEAKED AT THE Y-PORT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16722295 ↗
• MalfunctionNov 18, 2022Radiation Leak; Loose or Intermittent Connection; Radiation Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CUSTOMER REPORTS THAT A LINE WAS PLACED ON THE SECOND WAY (Y-JUNCTION) AND A CHEMOTHERAPY WAS BEING INFUSED. THE CONNECTION DID NOT HOLD AND THERE WAS A REFLUX THAT FROM THE NEEDLE WENT TOWARDS THE INFUSION LINE CAUSING LEAKAGE OF CYTOTOXIC.

  Patient problems: Chemical Exposure; Failure of Implant

  MAUDE report 15826337 ↗
• MalfunctionSep 11, 2022Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT THERE WAS NO BLOOD REFLUX DESPITE ATTEMPTS WITH THE SAME SAMPLE. THERE WERE NO ISSUES IDENTIFIED THE PREVIOUS TIMES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397871 ↗
• MalfunctionAug 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE LEAKED DURING INFUSION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272028 ↗
• MalfunctionMay 13, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE DEVICE WAS USED TO ACCESS PATIENT'S PORTAL AND THE USER COULD NOT ASPIRATE BLOOD BUT COULD NOT- AIR BUBBLES WERE SEEN. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817329 ↗
• MalfunctionMay 13, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE DEVICE WAS USED TO ACCESS PATIENT'S PORTAL AND THE USER COULD NOT ASPIRATE BLOOD BUT COULD NOT- AIR BUBBLES WERE SEEN. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817319 ↗
• MalfunctionApr 12, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT AND DEVICE SHOWED AIR IN THE TUBING. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649272 ↗
• MalfunctionApr 12, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT AND DEVICE SHOWED AIR IN THE TUBING. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649270 ↗
• MalfunctionMay 23, 2016Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE THE NEEDLE WOULD NOT ENGAGE INTO THE SAFETY MECHANISM. RESISTANCE WAS FELT UPON PULLING THE NEEDLE INTO THE MECHANISM. NO ADVERSE HEALTH OUTCOME RESULTED FROM THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5673696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021999. One submission often covers many models, so check the product and lot details in each record.

• Z-0253-2020 · Jul 15, 2019 · Terminated
  Port full Access Tray Product Code: DT19330