Deltec 21-2714-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586015786), received between Apr 23, 2021 and Apr 27, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PORT NEEDLE BROKE OFF (SNAPPED OFF) THE HANDLE PART LEAVING THE NEEDLE LEFT IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON MARCH 4, 2022 INDICATED THE NEEDLE WAS ABLE TO BE REMOVED WITHOUT HARM OR DISTRESS TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16827107 ↗
• MalfunctionSep 12, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN INSERTING THE NEEDLE INTO THE PORT-A-CATH THE NEEDLE BENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403339 ↗
• MalfunctionSep 12, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE SEEMED SOFT AND SLIGHTLY BENT AT THE SIDE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402911 ↗
• InjuryApr 23, 2021Separation Failure; Separation Failure

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC GRIPPER NEEDLE SEPARATED AND EMBEDDED UNDER THE SKIN INSIDE PORT. THE NURSE WENT TO ACCESS PORTACATH AND NOTICED CHILD WAS SCRATCHING SITE, SWAB OBTAINED AND REDRESSED. ON FLUSHING THE PORTACATH IT WAS NOTICED IT WAS LEAKING. NURSE ASKED ANOTHER MEMBER OF STAFF TO REVIEW. SHE TRIED TO REPLACE THE PORT NEEDLE, HOWEVER THE NEEDLE HAD NOT CAME OFF WITH THE GRIPPER AND WAS LEFT INSIDE SKIN. THE PLASTIC GRIPPER SECTION WAS REPORTED TO COMA AWAY. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL TO HAVE THE NEEDLE REMOVED UNDER GENERAL ANESTHETIC. NEEDLE WAS SUCCESSFULLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11720564 ↗

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;