Splittable Needle Introducer 28 GA (1.2F) x 20 mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333209590), received between Dec 9, 2020 and Aug 1, 2022 — classified as 2 malfunctions.

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

10 other recalls cover devices cleared under the same FDA submission (K920755); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Failure to Advance

  AN ATTEMPT WAS MADE TO INSERT A PICC. UPON ENTERING THE VEIN, THERE WAS BLOOD THAT CAME BACK FROM THE INTRODUCER (SO IT WAS IN THE VESSEL). THE PRACTITIONER THEN ATTEMPTED TO THREAD THE PICC LINE THROUGH AND THE CATHETER WOULD NOT PASS. THE PRACTITIONER HAD TO REMOVE THE INTRODUCER. SHE ATTEMPTED TO THREAD IT THROUGH THE INTRODUCER WHEN OUTSIDE OF THE PATIENT, BUT THE CATHETER WOULDN'T PASS.

  Patient problems: Insufficient Information

  MAUDE report 15138178 ↗
• MalfunctionDec 9, 2020Break; Difficult to Advance

  FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979694 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K920755. One submission often covers many models, so check the product and lot details in each record.

• Z-0285-06 · Mar 25, 2005 · Terminated
  16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
• Z-0287-06 · Mar 25, 2005 · Terminated
  16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing
• Z-0282-06 · Mar 25, 2005 · Terminated
  16 G / 5F Dual Lumen L-Cath catheter only.
• Z-0284-06 · Mar 25, 2005 · Terminated
  16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard
• Z-0288-06 · Mar 25, 2005 · Terminated
  16 G / 5F Dual Lumen L-Cath complete kit with U-Wing
• Z-0283-06 · Mar 25, 2005 · Terminated
  16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard
• Z-0286-06 · Mar 25, 2005 · Terminated
  16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte
• Z-0784-04 · Mar 9, 2004 · Terminated
  BD L-Cath EX (20ga x 15cm), L-Cath Catheter System
• Z-0783-04 · Mar 9, 2004 · Terminated
  BD L-Cath NN (24ga x 30cm), L-Cath Catheter System
• Z-0785-04 · Mar 9, 2004 · Terminated
  BD L-Cath EX (28ga x 20cm), L-Cath Catheter System