Deltec 21-2960-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10610586027680), received between Jan 13, 2021 and May 7, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT OCCLUSION OCCURS DURING PATIENT USE. THIS OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264853 ↗
• MalfunctionMay 11, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO PASS PHYSIOLOGICAL SALINE SOLUTION THROUGH THE INFUSION LINE WITH THE CLAMP RELEASED, BUT THE SOLUTION DID NOT FLOW PROPERLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916245 ↗
• MalfunctionSep 2, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CUSTOMER TRIED TO PASS MEDICAL FLUID THROUGH THE NEEDLELESS PORT CONNECTOR (A NAC) AND THE FEMALE LUER-LOCK CONNECTOR DURING THE PRE-USE CHECK, BUT WOULD NOT. NO PATIENT INJURY OR ADVERSE AFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353168 ↗
• MalfunctionJan 14, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT WHEN A NEGATIVE PRESSURE WAS APPLIED TO THE PRODUCT, AIR GOT MIXED IN. THE CUSTOMER SUSPECTED THAT THE AIR MAY HAVE COME FROM THE Y-SITE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11169685 ↗
• MalfunctionJan 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT WHEN A NEGATIVE PRESSURE WAS APPLIED TO THE PRODUCT, AIR GOT MIXED IN. THE CUSTOMER SUSPECTED THAT THE AIR MAY HAVE COME FROM THE Y-SITE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11166392 ↗

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