Deltec 21-2733-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10610586015847), received between Mar 30, 2017 and Nov 4, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K870866); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PATIENT RECEIVED PHYSIOLOGICAL SALINE THROUGH THE IMPLANTED VENOUS ACCESS SYSTEM TO FLUSH THE INFUSION PORT AND PREVENT BLOCKAGE. WHEN THE NURSE WAS PREPARING THE MATERIALS AND USING SALINE TO PRE-FLUSH THE IMPLANTED VENOUS INFUSION SYSTEM, THEY FOUND THAT THE SALINE COULD NOT BE INJECTED, AND NO FLUID CAME OUT OF THE NEEDLE. THE NURSE REPLACED THE IMPLANTED INTRAVENOUS INFUSION SYSTEM AND CONTINUED TO CARE FOR THE PATIENT'S INFUSION PORT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465485 ↗
• MalfunctionApr 1, 2025Failure to Deliver; Failure to Deliver

  IT WAS STATED REPORTED THAT THE DRUG SOLUTION WON'T FLOW. THE EVENT OCCURRED IN THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748456 ↗
• MalfunctionJul 18, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE NEEDLE WAS DISCONNECTED FROM THE HUB. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778784 ↗
• MalfunctionSep 9, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE LINE WOULD NOT PRIME PAST THE TOP OF THE LINE/NEEDLE AS IF THERE IS A BLOCKAGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397419 ↗
• InjurySep 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL IMPLANTABLE PORT WAS IN USE, FLUID BUILT AROUND THE PORT A CATH. PATIENT WAS ADMITTED TO THE HOSPITAL FOR REMOVAL OF THE PORT A CATH AND THE PATIENT BECAME IN A COMATOSE STATE. NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Coma

  MAUDE report 9101004 ↗
• InjurySep 20, 2019Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL IMPLANTABLE PORT WAS IN USE, IT HAD TO BE REPLACED WITH ANOTHER. IT WAS REPORTED THAT THE CATHETER WOULD NOT FIT INTO THE PORT. NO PATIENT INJURY OCCURRED AS A RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9101003 ↗
• InjuryMar 30, 2017Break; Break

  IT WAS REPORTED THAT A DELTEC® GRIPPER® NEEDLE WAS USED WITH A PORT-A-CATH AND KEPT IN SITU WHEN IT WAS OBSERVED THAT THE NEEDLE HAD BROKEN OFF FROM THE REST OF THE DEVICE AND THE NEEDLE REMAINED INSIDE THE PORT WITH THE END EXPOSED OUTSIDE OF THE PATIENT'S SKIN. THE DEVICE HAD BEEN IN USE FOR FIVE DAYS FOR DAILY INTRAVENOUS TREATMENT THE ISSUE WAS OBSERVED BY THE PATIENT'S PARENTS WHEN IT WAS DISCOVERED THAT THE GAUZE DRESSING THAT PROTECTED THE NEEDLE WAS STAINED WITH BLOOD. THE BROKEN NEEDLE WAS REVIEWED BY A DOCTOR AND SUCCESSFULLY REMOVED. THE PATIENT'S PORT HAD TO BE ACCESSED MORE FREQUENTLY FOR TREATMENT DUE TO THE DEVICE ISSUE. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00782.

  Patient problems: Blood Loss

  MAUDE report 6446564 ↗
• InjuryMar 30, 2017Break; Break

  IT WAS REPORTED THAT A DELTEC® GRIPPER® NEEDLE WAS USED WITH A PORT-A-CATH AND KEPT IN SITU WHEN IT WAS OBSERVED THAT THE NEEDLE HAD BROKEN OFF FROM THE REST OF THE DEVICE AND THE NEEDLE REMAINED INSIDE THE PORT WITH THE END EXPOSED OUTSIDE OF THE PATIENT'S SKIN. THE DEVICE HAD BEEN IN USE FOR FIVE DAYS FOR DAILY INTRAVENOUS TREATMENT THE ISSUE WAS OBSERVED BY THE PATIENT'S PARENTS WHEN IT WAS DISCOVERED THAT THE GAUZE DRESSING THAT PROTECTED THE NEEDLE WAS STAINED WITH BLOOD. THE BROKEN NEEDLE WAS REVIEWED BY A DOCTOR AND SUCCESSFULLY REMOVED. THE PATIENT'S PORT HAD TO BE ACCESSED MORE FREQUENTLY FOR TREATMENT DUE TO THE DEVICE ISSUE. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00824.

  Patient problems: Blood Loss

  MAUDE report 6446560 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K870866. One submission often covers many models, so check the product and lot details in each record.

• Z-0189-2020 · Jul 8, 2019 · Terminated
  GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL