Deltec 21-3465-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10610586033049), received between Jun 26, 2017 and Dec 4, 2025 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (15 reports).

2 other recalls cover devices cleared under the same FDA submission (K072657); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT BLOOD WAS LEAKING INTO THE Y PORT OF THE ACCESS KIT. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. THE EVENT OCCURRED AT THE HOSPITAL. EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715492 ↗
• MalfunctionOct 28, 2025Incomplete or Inadequate Connection; Air/Gas in Device; Incomplete or Inadequate Connection; Air/Gas in Device

  IT WAS REPORTED THAT FLUID FLUSHED OUT OF THE Y-SITE NEEDLELESS CONNECTION ON THE PORT AND WAS SUCKED BACK IN. REPORTER STATED THAT BLOOD ALSO DID NOT CLEAR FULLY FROM THE Y-SITE. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. REVIEW OF THE VIDEO PROVIDED SHOWED AIR BUBBLES IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404553 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD CAME OUT OF THE Y PORT CLOSEST TO THE PATIENT PORT NEEDLE. PER REPORTER, THE NURSE HAD GONE TO CHECK PLACEMENT ON THE PORT NEEDLE BEFORE DE-ACCESSING WHEN THEY SAW BLOOD RIGHT AT THE INSERTION SITE. PER REPORTER, THE NURSE FLUSHED AND HE PLOCKED THE LINE WITH 100-UNIT HEPARIN. THERE WAS NO MEDICAL INTERVENTION REQUIRED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375288 ↗
• MalfunctionOct 23, 2025Incomplete or Inadequate Connection; Air/Gas in Device; Incomplete or Inadequate Connection; Air/Gas in Device

  IT WAS REPORTED THAT FLUID FLUSHED OUT OF THE Y-SITE NEEDLELESS CONNECTION ON THE PORT AND WAS SUCKED BACK IN. REPORTER STATED THAT BLOOD ALSO DID NOT CLEAR FULLY FROM THE Y-SITE. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. REVIEW OF THE VIDEO PROVIDED SHOWED AIR BUBBLES IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368331 ↗
• MalfunctionMay 30, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT ENGAGE AND CONTRIBUTED TO A NEEDLE STICK. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115256 ↗
• MalfunctionMay 30, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT ENGAGE AND CONTRIBUTED TO A NEEDLE STICK. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115137 ↗
• MalfunctionMay 30, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT ENGAGE AND CONTRIBUTED TO A NEEDLE STICK OF THE NURSE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115109 ↗
• MalfunctionMay 21, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT AFTER THE END OF TREATMENT, WHEN THE NEEDLE WAS REMOVED USING THE SAFETY SYSTEM, THE NEEDLE CAME OUT OF THE SAFETY SYSTEM AND STABBED THE CAREGIVER. THERE WAS A RISK OF INJURY TO CAREGIVERS FROM A CONTAMINATED NEEDLE AND EXPOSURE TO BODILY FLUIDS. THE OUTCOME OF THE NEEDLE STICK INJURY WAS NOT PROVIDED.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 22061673 ↗
• MalfunctionMay 21, 2025Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISM OF THE DEICE WAS NOT ENGAGING. THE EVENT EXPOSED THE NURSE TO A NEEDLE STICK INCIDENT. SAFETY DID NOT ENGAGE AND NEEDLE STICK INJURY WHILE REMOVING THE IVAD FROM THE PATIENT DURING DISCHARGE - WENT TO EMPLOYEE HEALTH, HAD BLOOD WORK DONE AND RECEIVED PROPHYLAXIS MEDICATIONS AS A RESULT - PATIENT ALSO HAD BLOOD WORK DRAWN. THE DEFECTIVE PRODUCTS WERE DISCARDED IN SHARPS CONTAINER. PATIENT HAD BLOOD WORK DONE TO CONFIRM NEED FOR PROPHYLAXIS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22058222 ↗
• InjuryMay 21, 2025Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISM OF THE DEICE WAS NOT ENGAGING. THE EVENT EXPOSED THE NURSE TO A NEEDLE STICK INCIDENT. SAFETY DID NOT ENGAGE AND NEEDLE STICK INJURY WHILE REMOVING THE IVAD FROM THE PATIENT DURING DISCHARGE - WENT TO EMPLOYEE HEALTH, HAD BLOOD WORK DONE AND RECEIVED PROPHYLAXIS MEDICATIONS AS A RESULT - PATIENT ALSO HAD BLOOD WORK DRAWN. THE DEFECTIVE PRODUCTS WERE DISCARDED IN SHARPS CONTAINER. PATIENT HAD BLOOD WORK DONE TO CONFIRM NEED FOR PROPHYLAXIS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22058218 ↗
• MalfunctionOct 1, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHILE PURGING, THEY NOTICED THAT IT WAS NOT POSSIBLE TO PURGE THE PRODUCT FROM THE DISTAL END, IF THEY ACCESSED FROM THE CONNECTOR, THEY COULD PURGE THE TOP PART, BUT NOT THE DISTAL END. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347947 ↗
• MalfunctionMay 29, 2024Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN PRIMING THE DEVICE THEY SAW SALINE SOLUTION CAME OUT FROM THE BLUE TUBE SINCE IT HAD A CLEAN AND WIDE CUT. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED HARM, MEDICAL INTERVENTION, OR ADVERSE OUTCOME AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19416043 ↗
• InjurySep 28, 2023Fluid/Blood Leak; Material Fragmentation; Unexpected/Unintended Radiation Output; Fluid/Blood Leak; Material Fragmentation; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THE IV TUBING WAS STUCK IN THE PROXIMAL PORT OF THE GRIPPER PLUS. PORT OF THE GRIPPER PLUS BROKE OFF, LEAVING THE LINE OPEN/BROKEN. THE PATIENT NEEDED TO BE DE-ACCESSED AND RE-ACCESSED. THE PROXIMAL NEEDLELESS PORT SHATTERED. THIS CAUSED DEBRIS AND CHEMOTHERAPY MEDICATION TO GO INTO THE EMPLOYEE'S EYE. THE EMPLOYEE WAS ASSESSED IN "EMPLOYEE HEALTH". NO FURTHER FOLLOW UP NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17833184 ↗
• MalfunctionSep 21, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORT THAT UPON HOSPITAL USE, THE NEEDLE PRESENTED GREAT RESISTANCE AND COULD NOT BE FLUSHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462045 ↗
• MalfunctionSep 10, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT, IN THREE (3) INSTANCES, THE DEVICE FROM THE SAME LOT NUMBER, WAS UNABLE TO DRAW. IT IS SUSPECTED THAT WHEN PULLING BACK ON THE SYRINGES, THE SIDE LUER LOCK WAS NOT SEALING TO GET ENOUGH PRESSURE IN ORDER TO GET THAT DRAW BACK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397571 ↗
• MalfunctionSep 9, 2022Flushing Problem; Flushing Problem

  IT WAS REPORTED THAT, WHEN THE NURSE ACCESSED THE PORT, SHE WAS NOT ABLE TO FLUSH THE LINE. A DIFFERENT SALINE FLUSH WAS USED, BUT IT DID NOT FLUSH. SHE DE-ACCESSED THE PATIENT AND RE-ACCESSED WITH ANOTHER PORT NEEDLE AND WAS ABLE TO FLUSH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397426 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597202 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595050 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594993 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594973 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594845 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594716 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594702 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594685 ↗
• MalfunctionMar 30, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR ENTERED THE DELTEC GRIPPER PLUS NEEDLE DURING A DRAW. THE PATIENT HAD TO BE RE-ACCESSED AS A RESULT. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072657. One submission often covers many models, so check the product and lot details in each record.

• Z-2499-2020 · Jun 11, 2020 · Terminated
  PORT-A-CATH II POWER P.A.C. Low Profile" system.
• Z-0190-2020 · Jul 8, 2019 · Terminated
  GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2.