Deltec 21-2767-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10610586025600), received between Apr 17, 2017 and Apr 14, 2026 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (12 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Blocked Connection

  IT WAS REPORTED THAT THE NEEDLE PRESENTED OBSTRUCTION, PREVENTING THE FLOW OF THE SOLUTION. THE ISSUE WAS OBSERVED DURING THE FLUSHING OR PRIMING PROCESS. AS A MEDICAL INTERVENTION DUE TO THIS ISSUE, THE INSERTION SET WAS REPLACED. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876794 ↗
• MalfunctionJan 6, 2026Fail-Safe Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A SELF-INFLICTED NEEDLE STICK. WHEN THE NURSE ATTEMPTED TO ACTIVATE THE NEEDLE SAFETY MECHANISM, THE NEEDLE SEPARATED FROM THE SAFETY FRAME. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974989 ↗
• MalfunctionNov 5, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT WHEN THE NURSE WENT TO REMOVE THE GRIPPER, THE NEEDLE DID NOT MAKE THE USUAL CLICK, AND THE SAFETY NEEDLE WAS FOUND DETACHED FROM THE SYSTEM, CAUSING HER TO PRICK HERSELF. WHEN REMOVING THE NEEDLE, IT WHIPPED OUT SIDEWAYS, PRICKING THE NURSE AND ALSO TEARING THE SKIN OF THE CHILD CARRYING THE RESERVOIR. THE STATUS OF THE PRODUCT AT THE EVENT WAS AFTER CONNECTING TO THE PATIENT, WHILE TAKE OUT THE NEEDLE TO FINISH THE TREATMENT. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED BUT WAS A DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476182 ↗
• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING NORMAL USE, THE PROTECTIVE CAP OF THE PORT NEEDLE HAD COME OFF AT THE CONNECTION POINT, RESULTING IN A NEEDLESTICK INJURY TO THE OPERATING NURSE. THE INCIDENT OCCURRED DURING SET UP AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427390 ↗
• MalfunctionOct 23, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR THE PUMP DISCONNECT, THE PORT COULDN¿T BE FLUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516968 ↗
• MalfunctionOct 23, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR THE PUMP DISCONNECT, THE PORT COULDN¿T BE FLUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516330 ↗
• MalfunctionOct 23, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR THE PUMP DISCONNECT, THE PORT COULDN¿T BE FLUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516258 ↗
• MalfunctionOct 23, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR THE PUMP DISCONNECT, THE PORT COULDN¿T BE FLUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516039 ↗
• MalfunctionOct 23, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR THE PUMP DISCONNECT, THE PORT COULDN'T BE FLUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515825 ↗
• MalfunctionOct 23, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR THE PUMP DISCONNECT, THE PORT COULDN¿T BE FLUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515775 ↗
• MalfunctionOct 23, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR THE PUMP DISCONNECT, THE PORT COULDN¿T BE FLUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515618 ↗
• MalfunctionAug 8, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE NURSE WAS UNABLE TO FLUSH THE PORTS, AND THEY HAD TO RE-ACCESS THEM. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944304 ↗
• MalfunctionApr 29, 2024Device Dislodged or Dislocated; Separation Problem; Device Dislodged or Dislocated; Separation Problem

  IT WAS REPORTED THAT DURING USE THE NEEDLE WAS PULLED OUT OF THE PROTECTIVE SHELL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201253 ↗
• MalfunctionNov 30, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE NEEDLE WAS "TOO HIGH ABOVE THE LEVEL OF THE CHILDREN'S SKIN AFTER BEING PUNCTURED, WHICH CAUSED ACCIDENTAL HITS AND THE CATHETERS BECAME LOOSE". THERE WAS EXTRAVASATION OF SERUM THERAPY IN SEVERAL PATIENTS. THE NEEDLE BENT INSIDE THE CATHETER, CAUSING HARM TO PATIENTS. THERE WAS PATIENT INVOLVED, BUT IT IS UNKNOWN THE EXACT QUANTITY AND REPORTED HARM. IT WAS UNKNOWN IF THERE WAS ANY MEDICAL INTERVENTION OR TREATMENT.

  Patient problems: Insufficient Information

  MAUDE report 18240592 ↗
• MalfunctionApr 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED PER ANVISA (B)(4) THAT WHEN PERFORMING A CATH PUNCTURE WITH A 0.9MM X 19MM GRIPPER, OBSTRUCTION WAS OBSERVED, WITH NEGATIVE FLOW WHEN SALINIZING WITH POSIFLUSH. PUNCTURE PERFORMED WITHOUT DIFFICULTIES, WITH A CENTRALIZED NEEDLE PROPERLY PLACED IN THE RESERVOIR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693754 ↗
• MalfunctionApr 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE NEEDLE WAS USED TO PUNCTURE THE CATHETER, BUT THERE WAS NO EBB AND FLOW IN THE CATHETER, THE NEEDLE WAS OBSTRUCTED. TRYING TO INJECT SALINE, BUT IT DIDN'T WORK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693720 ↗
• MalfunctionFeb 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CONTINUOUS INFUSION PUMP WAS INSTALLED IN A PORT-A-CATH CATHETER VIA A HUBBER NEEDLE. AT THE END OF THE CHEMOTHERAPY CONTENT, EXTRAVASATION FROM THE NEEDLE WAS NOTICED. THE ISSUE WAS FOUND DURING USE WITH A PATIENT, BUT NO PATIENT INJURY WAS IDENTIFIED.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371505 ↗
• MalfunctionFeb 8, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CONTINUOUS INFUSION PUMP WAS INSTALLED IN A PORT-A-CATH CATHETER VIA A HUBBER NEEDLE. AT THE END OF THE CHEMOTHERAPY CONTENT, EXTRAVASATION FROM THE NEEDLE WAS NOTICED. THE ISSUE WAS FOUND DURING USE WITH A PATIENT, BUT NO PATIENT INJURY WAS IDENTIFIED.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321280 ↗
• MalfunctionSep 12, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PRODUCT HAD A NEEDLE OBSTRUCTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406410 ↗
• MalfunctionSep 12, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT UPON PRIMING THE PORT NEEDLE, THE PORT TUBING DID NOT FLUSH THROUGH THE NEEDLE AND MET RESISTANCE WITH PRIMING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401866 ↗
• MalfunctionSep 9, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT WHEN THE USER INJECT THROUGH THE POWER PORT TUBING THE PRESSURE WILL RISE UP; BUT AT 300 PSI, IT WOULD BE CONSIDERED PRESSURE LIMITING AND THE INJECTOR ITSELF WILL SUDDENLY DROP THE RATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397431 ↗
• MalfunctionSep 9, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT WHEN THE USER INJECT THROUGH THE POWER PORT TUBING THE PRESSURE WILL RISE UP; BUT AT 300 PSI, IT WOULD BE CONSIDERED PRESSURE LIMITING AND THE INJECTOR ITSELF WILL SUDDENLY DROP THE RATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397430 ↗
• InjurySep 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LOSS OF DRUGS WERE DETECTED IN THREE (3) PATIENTS WITH STANDARD HOME CHEMOTHERAPY INFUSIONS. PATIENTS PRESENTED A PUNCTURE AREA WITH A CRYSTALLIZED APPEARANCE AROUND THE DEVICE, AND ONE OF THE PATIENTS PRESENTED A SKIN LESION AT THE RESERVOIR SITE. LOCAL AND ORAL ANTIBIOTIC PRESCRIPTIONS WERE REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Needle Stick/Puncture; Reaction to Medicinal Component of Device

  MAUDE report 15366422 ↗
• InjurySep 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LOSS OF DRUGS WERE DETECTED IN THREE (3) PATIENTS WITH STANDARD HOME CHEMOTHERAPY INFUSIONS. PATIENTS PRESENTED A PUNCTURE AREA WITH A CRYSTALLIZED APPEARANCE AROUND THE DEVICE, AND ONE OF THE PATIENTS PRESENTED A SKIN LESION AT THE RESERVOIR SITE. LOCAL AND ORAL ANTIBIOTIC PRESCRIPTIONS WERE REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Localized Skin Lesion; Needle Stick/Puncture; Reaction to Medicinal Component of Device

  MAUDE report 15366390 ↗
• InjurySep 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LOSS OF DRUGS WERE DETECTED IN THREE (3) PATIENTS WITH STANDARD HOME CHEMOTHERAPY INFUSIONS. PATIENTS PRESENTED A PUNCTURE AREA WITH A CRYSTALLIZED APPEARANCE AROUND THE DEVICE, AND ONE OF THE PATIENTS PRESENTED A SKIN LESION AT THE RESERVOIR SITE. LOCAL AND ORAL ANTIBIOTIC PRESCRIPTIONS WERE REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Needle Stick/Puncture; Reaction to Medicinal Component of Device

  MAUDE report 15358735 ↗

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