Deltec 21-2968-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10610586027765), received between May 11, 2019 and Nov 12, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT SHOWED LEAKAGE WITH THE NEEDLE, AS IF IT HAD BECOME DISLODGED FROM THE RESERVOIR, DESPITE APPARENTLY HAVING NO DAMAGE OR DEFECT. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PATIENT USE AND THERE WAS DELAY IN THERAPY, HOWEVER, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535084 ↗
• MalfunctionNov 12, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT SHOWED LEAKAGE WITH THE NEEDLE, AS IF IT HAD BECOME DISLODGED FROM THE RESERVOIR, DESPITE APPARENTLY HAVING NO DAMAGE OR DEFECT. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING PATIENT USE AND THERE WAS DELAY IN THERAPY, HOWEVER, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534570 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT WHILE THE NURSE WAS FLUSHING THE PUMP WITH NACL, IT SEEMED THAT THE FLUID WAS SPURTING OUT FROM THE STROKE OF THE VENIPUNCTURE NEEDLE. ON CLOSER INSPECTION OF THE VENIPUNCTURE NEEDLE, WHICH HAD BEEN DISCONTINUED, A HOLE WAS FOUND IN THE STROKE. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415434 ↗
• MalfunctionJun 16, 2022Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT PRIMING WAS IMPOSSIBLE DURING MATERIAL PREPARATION. IT WAS IMPOSSIBLE TO INJECT INTO DEVICE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714503 ↗
• MalfunctionApr 8, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT UPON REMOVAL FROM THE PATIENT, THE NURSE PRICKED HERSELF WITH THE NEEDLE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9940825 ↗
• MalfunctionMay 11, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE TUBING ON A SMITHS MEDICAL GRIPPER PLUS BECAME DETACHED AT THE Y SITE. THE REPORTER STATED THE DEVICE ISSUE WAS NOT NOTICED IMMEDIATELY AND AS A RESULT THE PATIENT HAD A "SIGNIFICANT LOSS OF BLOOD". THE REPORTER STATED WHEN THE ISSUE WAS NOTICED THE DEVICE WAS REPLACED WITH ANOTHER AND THE PATIENT NEEDED CONSTANT MONITORING AND BLOOD COUNT EVALUATION. NO FURTHER EFFECTS TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8602373 ↗

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