Deltec 21-2865-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10610586025693), received between May 26, 2016 and May 5, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RUBBER STOPPER AT THE Y SITE BROKE IN HALF WHILE IN USE WITH A PATIENT. THE DEVICE LEAKED MEDICATION, SALINE AND BLOOD ONTO THE PATIENT AND DISPOSABLE CURTAIN. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961661 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT WAS LEAKING SALINE ON THE PATIENT. THE EVENT OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961651 ↗
• MalfunctionOct 15, 2024Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT A PATIENT WENT HOME WITH THE PUMP AND FLUID WAS LEAKING FROM PORT. PATIENT MENTIONED IT THEN LEAKED AGAIN AFTER REINSERTION. THERE WAS PATIENT INVOLVEMENT, BUT NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453450 ↗
• MalfunctionOct 15, 2024Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT WHEN THEY REMOVED THE NEEDLE THEY HEARD AND FELT THE CLICK OFF THE SAFETY NEEDLE. WHEN THEY WERE PUTTING THE NEEDLE IN THE SHARPS BIN THE NEEDLE CLICKED BACK OUT AND STABBED THEM IN THE MIDDLE FINGER. THERE WAS PATIENT INVOLVEMENT, BUT NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453234 ↗
• MalfunctionJun 7, 2017Protective Measures Problem; Protective Measures Problem

  THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619502 ↗
• MalfunctionJun 3, 2016Protective Measures Problem; Protective Measures Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5697687 ↗
• MalfunctionMay 26, 2016Protective Measures Problem; Protective Measures Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5683781 ↗

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