Deltec 21-2770-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10610586025631), received between Jul 20, 2017 and Aug 8, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT SALINE SOLUTION COULD NOT BE INJECTED INTO THE DEVICE DURING THE PRE-TEST BEFORE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754900 ↗
• MalfunctionJul 22, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A RESISTANCE WHEN CUSTOMER TRIED THE TEST DOSE. IT IS UNCLEAR IF IT WAS INSERTED INTO THE PORT. THE EVENT OCCURRED DURING UNKNOWN TIME AT FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569187 ↗
• MalfunctionJul 8, 2025Complete Blockage; Coagulation in Device or Device Ingredient; Obstruction of Flow; Complete Blockage; Coagulation in Device or Device Ingredient; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A LINE BLOCKAGE, AS SALINE DID NOT FLOW. THE EVENT OCCURRED DURING PRIMING AT THE FACILITY, PRIOR TO PATIENT USE. NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441489 ↗
• MalfunctionMay 12, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE LINE HAD BLOCKAGE. SALINE DID NOT SEEM TO FLOW EVEN AFTER THE CLAMP WAS RELEASED. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THIS OCCURRED BEFORE PATIENT USE DURING PRIMING. THERE NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006392 ↗
• MalfunctionMay 1, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT, "IT IS IMPOSSIBLE TO PURGE THE NEEDLE." THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942560 ↗
• MalfunctionMay 1, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT "IT WAS IMPOSSIBLE TO PURGE THE NEEDLE." THE NURSES CHANGED THE NEEDLE WITH ONE OF THE SAME LOT NUMBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942519 ↗
• MalfunctionMar 26, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO INJECT LIQUID WITH A SYRINGE. THE EVENT OCCURRED IN THE FACILITY. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THIS OCCURRED BEFORE PATIENT USE, DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698468 ↗
• MalfunctionMar 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE LINE HAD BLOCKAGE. SALINE DID NOT SEEM TO FLOW EVEN AFTER THE CLAMP WAS RELEASED. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THIS OCCURRED BEFORE PATIENT USE DURING PRIMING. THERE NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638335 ↗
• MalfunctionJan 14, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT "WHEN PRIMING, THE NEEDLE TIP CANNOT BE FILLED DUE TO RESISTANCE. THERE SEEMS TO BE A BLOCKAGE ALONG THE WAY". 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 21152401 ↗
• MalfunctionSep 22, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHEN PERFORMING PRIMING AT A PRE-USE CHECK, THE CUSTOMER NOTICED MEDICAL FLUID DID NOT PASS THROUGH THE PRODUCT DUE AN OCCLUSION IN IT.. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15466980 ↗
• MalfunctionSep 14, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING PRE-USE FLUSH THERE WAS AN ABSENCE OF FLUID THAT PASSED THROUGH THE DEVICE. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417167 ↗
• MalfunctionSep 14, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING PRE-USE FLUSH THERE WAS AN ABSENCE OF FLUID THAT PASSED THROUGH THE DEVICE. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417163 ↗
• MalfunctionSep 12, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT WHEN PERFORMING A FLUSHING AT A PRE-USE CHECK, THE CUSTOMER FOUND AN OCCLUSION IN THE PRODUCT'S TUBE LINE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405439 ↗
• MalfunctionMay 18, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC GRIPPER PLUS NEEDLES MALFUNCTIONED. THE REPORT INDICATED DURING ACCESSING PORT FOR CHEMO TREATMENT THE DEVICE FLUSHED WELL PRIOR TO INSERTION. UPON INSERTION LOUD "CLICK" HEARD AND NEEDLE BENT TO APPROX. 45 DEGREES. DEVICE IMMEDIATELY REMOVED AND REPORTED WAS IN INTACT. PORT RE-ACCESSED WITH ANOTHER GRIPPER AND HAD NO ISSUE. NO ADVERSE PATIENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845105 ↗
• MalfunctionJul 21, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE STICK PREVENTION MECHANISM OF A DELTEC® GRIPPER PLUS® SAFETY NEEDLE DID NOT WORK, AND THE NEEDLE COULD NOT BE STOWED IN THE PRODUCT. ANOTHER NEEDLE WAS USED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6732395 ↗
• MalfunctionJul 20, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE STICK PREVENTION MECHANISM OF A DELTEC® GRIPPER PLUS® SAFETY NEEDLE DID NOT WORK, AND THE NEEDLE COULD NOT BE STOWED IN THE PRODUCT. ANOTHER NEEDLE WAS USED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6729427 ↗

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