Deltec 21-2961-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10610586027697), received between Mar 23, 2017 and Feb 10, 2026 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Fluid/Blood Leak

  IT WAS STATED THAT THERE WAS AN EQUIPMENT MALFUNCTION ENCOUNTERED IN THE ONCOLOGY DAY HOSPITAL (HDJ) DURING A CHEMOTHERAPY SESSION. THE NURSE NOTICED A DROP-BY-DROP LEAKAGE AT THE LEVEL OF THE GRIPPER VALVE. FURTHER ON, IT WAS NOTICED THAT THE CHEMOTHERAPY SOLUTION LEAKED ONTO THE PATIENT¿S CLOTHING. THE INFUSION WAS STOPPED AND THE PATIENT¿S SKIN WAS DECONTAMINATED. AT THAT TIME, NO SKIN REACTION HAS BEEN OBSERVED. THE PATIENT WAS SEEN AGAIN, THE NEXT DAY FOR SKIN DECONTAMINATION. THERE WAS PATIENT INVOLVEMENT AND NO CLINICAL CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303085 ↗
• MalfunctionApr 21, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE SALINE WON'T FLOW. THE CUSTOMER TRIED TO PUSH IT OUT, BUT THE SYRINGE PLUNGER IS TOO HARD. THE EVENT OCCURRED BEFORE PATIENT USE AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875998 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT PATIENT ON CHEMO WAS SENT HOME WITH BAXTER INFUSER PUMP, AND IT WAS FOUND OUT THAT CHEMO WAS LEAKING UNDER THE PAC GRIPPER. TESTING ON THE DEVICE WAS PERFORMED USING FLUSHING WITH NORMAL SALINE TO FIND THE LEAK AND SMALL LEAK UNDER GRIPPER WAS FOUND. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864912 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE CLEANING OF THE DEVICE WITH SALINE, THE NURSE NOTICED A LEAK AT THE Y-SITE. THE PLASTIC TUBE APPEARS TO BE BROKEN ON HALF OF THE DIAMETER OF THE RIGID PLASTIC BASE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301361 ↗
• MalfunctionSep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN FLUSHING GRIPPER, NOTED SOLUTION TO BE POOLING ON PROXIMAL PORT MEMBRANE ON OUTSIDE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251080 ↗
• MalfunctionSep 5, 2023Crack; Air/Gas in Device; Crack; Air/Gas in Device

  IT WAS REPORTED THAT DURING PATIENT USE IT WAS NOTICED THAT THE Y SITE PART WAS CRACKED. WHEN THE NEEDLE WAS REMOVED, HEPARIN WAS LOCKED, BUT THE AIR BUBBLED IN AND COULD NOT BE RELEASED FROM THE SYRINGE. THE MEDICATION BEING INFUSED AT THE TIME WAS CHEMO. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684883 ↗
• MalfunctionMay 11, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED, THAT THE CUSTOMER INFUSED MEDICAL FLUID (PHYSIOLOGICAL SALINE SOLUTION) INTO THE PATIENT THROUGH THE PRODUCT USING A SYRINGE. BUT BACKFLOW OF MEDICAL FLUID WAS NOT OBSERVED. SO THE CUSTOMER REMOVED THE PRODUCT FROM THE PATIENT, AND PASSED MEDICAL FLUID THROUGH THE PRODUCT WITH THE SYRINGE CONNECTED. HOWEVER, AT THAT TIME, MEDICAL FLUID WAS UNABLE TO BE DRAWN (ONLY AIR BUBBLE WERE DRAWN). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916265 ↗
• MalfunctionSep 11, 2022Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT THE DEVICE FAILED TO PRIME DURING PRE-USE CHECK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397870 ↗
• MalfunctionSep 10, 2022Flushing Problem; Flushing Problem

  IT WAS REPORTED THAT THE CUSTOMER PERFORMED A PRIMING WITHOUT PROBLEM AND WAS ABLE TO CONFIRM A BLOOD RETURN FROM THE PATIENT. HOWEVER, UPON FLUSHING, HE NOTICED THAT THE MEDICAL FLUID WAS UNABLE TO BE INFUSED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397560 ↗
• MalfunctionSep 6, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE SYRINGE CONNECTED TO THE PRODUCT AT A PRESSURE CHECK WAS CAUSING MORE AMOUNT OF AIR BEING DRAWN. THE CUSTOMER SUSPECTED LEAKAGE OF AIR OCCURRED WITH THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363123 ↗
• MalfunctionAug 23, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THE INFUSION ROUTE WAS OCCLUDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277970 ↗
• InjuryAug 4, 2022Use of Device Problem; Infusion or Flow Problem; Use of Device Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE SKIN AT THE PUNCTURE SITE BECAME SUPPURATED. ADDITIONALLY THE REPORTER STATED "I RECOGNIZE THAT IT IS A PROBLEM WITH THE TECHNIQUE, BUT I WOULD LIKE YOU TO ANALYZE THE PRODUCT AS WELL FOR GOOD LIQUID FLOW."

  Patient problems: Post Operative Wound Infection

  MAUDE report 15163218 ↗
• MalfunctionMar 23, 2017Difficult to Remove; Protective Measures Problem; Difficult to Remove; Protective Measures Problem

  IT WAS REPORTED THAT A DELTEC® GRIPPER PLUS® SAFETY NEEDLE WAS DIFFICULT TO TAKE OUT OF THE PORT DUE TO TIGHTNESS AND WHEN IT WAS REMOVED FORCEFULLY, THE SAFETY DID NOT FUNCTION. THIS WAS OBSERVED IMMEDIATELY UPON USE WITH A PATIENT. IT WAS NOTED THAT THE DEVICE WAS CHECK IN ACCORDANCE WITH ITS INSTRUCTIONS FOR USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6427449 ↗

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