Deltec 21-2734-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586015854), received between Mar 22, 2019 and May 21, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 16, 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.

• MalfunctionMay 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PORT NEEDLE WAS NOT BENT WHEN INSERTED, BUT WHEN CHANGING IT AFTER 7 DAYS, THE TIP OF THE NEEDLE WAS BENT. THIS OCCURRED WITH 2 NEEDLES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19362482 ↗
• MalfunctionSep 1, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE NEEDLE OBSTRUCTION DOES NOT ALLOW LIQUID THROUGH. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334483 ↗
• MalfunctionApr 26, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS BREAKAGE OF DELIVERY. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207339 ↗
• InjuryMar 22, 2019Structural Problem; Sharp Edges; Structural Problem; Sharp Edges

  IT WAS REPORTED THAT WHILE A SMITHS MEDICAL GRIPPER NEEDLE WAS IN USE, IT HAD BEEN BENT. UPON REMOVAL OF THE NEEDLE, THE PATIENT WAS LEFT WITH A CUT. IT WAS REPORTED TO HAVE TAKEN 45 MINUTES TO STOP THE BLEEDING AS THE USE OF APPLIED PRESSURE AND COOLPACK HAD NO EFFECT. TRANEXAMIC ACID WAS USED TO END THE BLEEDING. IT WAS ALSO REPORTED THAT A HEMATOMA HAD FORMED. PATIENT WAS SUPPLIED WITH PAIN KILLERS.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 8446372 ↗

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