Deltec 21-2766-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10610586025594), received between Jun 5, 2017 and Feb 26, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (7 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Fail-Safe Problem

  IT WAS REPORTED THAT NEEDLE DID NOT LOCK INTO SAFETY POSITION WHEN DISCONNECTED FROM PATIENT. THE NEEDLE PULLED OUT PAST THE SAFETY STOP AND CAUSED AN ACCIDENTAL NEEDLE POKE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS A PATIENT INVOLVEMENT AND THERE NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462903 ↗
• MalfunctionFeb 3, 2026Fail-Safe Problem

  IT WAS REPORTED THAT THE NEEDLE PULLED OUT PAST THE SAFETY STOP AND CAUSED AN ACCIDENTAL NEEDLE POKE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250009 ↗
• MalfunctionNov 3, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT CANNOT INJECT THE SOLUTION. THERE IS A BLOCKAGE. THIS OCCURRED DURING PRIMING IN EARLY (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457083 ↗
• MalfunctionOct 29, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE NEEDLE WAS PULLING OUT PAST THE SAFETY DEVICE AND EXPOSING THE TIP OF THE NEEDLE. THE ISSUE OCCURRED WHILE RETRACTING THE NEEDLE FROM THE PATIENT. THE WAS MEDICAL INTERVENTION WAS BLOOD TESTING FOR NURSE. THE OUTCOME OF THE EVENT WAS ONGOING. THERE WAS NO PATIENT HARM REPORTED BUT THE NURSE WAS POKED BY NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415520 ↗
• MalfunctionMay 12, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED CHEMICALS IN THE DEVICE DID NOT PASS THROUGH. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006047 ↗
• MalfunctionDec 6, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT "THE ROUTE WAS BLOCKED, SO THE OPERATOR COULDN'T DO THE RAW FOOD FLASH". THE EVENT OCCURRED DURING PRIMING, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860872 ↗
• MalfunctionAug 20, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT UPON ACCESS, IT HAS SLOW FLUSHING, SLOW BLOOD DRAW, THEN COULD BARELY FLUSH SALINE IN. DECEASED, THEN THE NEEDLE ALMOST TOTALLY OCCLUDED WHEN FLUSHED AFTER DECEASED. REACCESSES FOR INFUSION. NO ALARMS BUT STILL HARD FLUSHING WITH HEPARIN. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008082 ↗
• MalfunctionJun 5, 2024Complete Blockage; Difficult to Flush; Complete Blockage; Difficult to Flush

  IT WAS REPORTED THAT "DRUG DID NOT ROUTE DURING FRESH FOOD FLUSH PRIOR TO PATIENT USE". THIS OCCURRED DURING PRIMING, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467857 ↗
• MalfunctionApr 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE LEAKED AT HUB OF THE GRIPPER WITH A MICROCLAVE ATTACHED. STAFF ATTEMPTED TO TIGHTEN BUT CONTINUED TO LEAK. STAFF REPLACED THE MICROCLAVE AND LEAKING CONTINUED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125754 ↗
• MalfunctionMay 11, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER HAD DIFFICULTY PASSING MEDICAL FLUID THROUGH THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915943 ↗
• MalfunctionMay 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE BOTTOM OF THE TUBING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882776 ↗
• MalfunctionMay 4, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN USING, IT WAS FOUND THAT ONE NEEDLE WAS BLOCKED AND THE TIP OF ONE NEEDLE WAS CROOKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869348 ↗
• MalfunctionSep 12, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO PERFORM A PRIMING OF THE PRODUCT DURING THE PRE-USE CHECK, BUT COULD NOT DO IT SUCCESSFULLY BECAUSE HE FELT RESISTANCE THROUGH THE TUBING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406829 ↗
• MalfunctionSep 9, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT, DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THAT THE MEDICAL FLUID WAS UNABLE TO PASS THROUGH IT; AN OCCLUSION WAS OBSERVED IN THE PRODUCT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397449 ↗
• MalfunctionSep 9, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT, THE CUSTOMER CONNECTED A SYRINGE TO THE PRODUCT AND ATTEMPTED TO INFUSE MEDICAL FLUID TO THE PATIENT THROUGH THE PRODUCT, BUT COULD NOT DO IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397442 ↗
• MalfunctionSep 9, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED MEDICAL FLUID WAS UNABLE TO PASS THROUGH IT. ALSO, AN OCCLUSION WAS OBSERVED IN THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397427 ↗
• MalfunctionSep 9, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT, AFTER CONNECTING THE PRODUCT TO A SOLUTION ADMINISTRATION SET, WHEN THE CUSTOMER WAS PRIMING, HE NOTICED THAT THE MEDICAL FLUID COULD NOT PASS THROUGH THE PRODUCT SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397420 ↗
• MalfunctionJul 22, 2022Device Damaged Prior to Use; Obstruction of Flow; Material Twisted/Bent; Device Damaged Prior to Use; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED THAT DURING USE, A NEEDLE WAS FOUND BLOCKED AND A SECOND NEEDLE TIP WAS CROOKED. PHOTO OF PRODUCT PACKAGE ATTACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088419 ↗
• MalfunctionJun 22, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT HE CUSTOMER ATTEMPTED TO PERFORM A PRIMING DURING THE PRE-USE CHECK, BUT MEDICAL FLUID WOULD NOT PASS THROUGH THE PRODUCT SUCCESSFULLY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14774324 ↗
• MalfunctionApr 14, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED MEDICAL FLUID WOULD NOT PASS THROUGH THE PRODUCT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112252 ↗
• MalfunctionAug 27, 2021Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT AFTER THE USE OF THE PRODUCT, A CLICK SOUND WAS HEARD WHEN THE CUSTOMER PULLED UP THE SAFETY ARM. THE NEEDLE WAS NOT SUCCESSFULLY LOCKED AND THE SAFETY MECHANISM WAS FOUND BROKEN. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380842 ↗
• MalfunctionFeb 28, 2021Fail-Safe Problem; Fail-Safe Did Not Operate; Fail-Safe Problem; Fail-Safe Did Not Operate

  INVESTIGATION RESULTS COMPLETED AND SUMMARY IN H10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11391034 ↗
• MalfunctionDec 9, 2020Retraction Problem; Retraction Problem

  INFORMATION RECEIVED A IMPLANTABLE PORTS/DELTEC GRIPPER PLUS NEEDLES HAD AN EXPOSED NEEDLE THAT WOULD NOT RETRACT BACK INTO THE SAFETY ARM. THIS OCCURRED DURING USE, NO PATIENT INJURY OCCURRED OR REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10977870 ↗
• MalfunctionMay 20, 2020Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED INDICATING THAT NEEDLE STICK OCCURRED WITH USE OF A SMITHS MEDICAL DELTEC GRIPPER PLUS SAFETY NEEDLE. IT WAS REPORTED THAT THE SAFETY ARM WOULD NOT LOCK, AND THE NEEDLE SPRUNG OUT OF IT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10074550 ↗
• MalfunctionMar 12, 2018Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE "NEEDLE PRICK PREVENTION FUNCTION" OF A DELTEC® GRIPPER PLUS® SAFETY NEEDLE DID NOT WORK. THE FAULT OCCURRED WHILE REMOVING THE NEEDLE FROM THE PATIENT AFTER "THE NEEDLE BASE WAS UNABLE TO BE LOWERED". NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7332068 ↗

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