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First PICC™ S/L Peripherally Inserted Central Catheter 384158Recalls & reported problems

Argon Medical Devices, Inc. · First PICC™ S/L Peripherally Inserted Central Catheter 16ga (5F) 1.70mm x 65cm · Class 2 · Implant

All models of First PICC S/L Peripherally Inserted Central Catheter (5)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333209699), received between Aug 18, 2022 and Sep 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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

Device problems

  • Difficult to Remove1
  • Fluid/Blood Leak1
  • Malposition of Device1
  • Material Rupture1
  • Material Twisted/Bent1
  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 12, 2022Difficult to Remove; Malposition of Device; Material Twisted/Bent; Physical Resistance/Sticking

    "WHEN REMOVING THE GUIDE WIRE, IT SHOWED RESISTANCE TO REMOVAL. AFTER SEVERAL MANEUVERS, THE WIRE WAS REMOVED IN ONE PIECE. WHEN VISUALIZING THE CATHETER, VIA X-RAY, IT WAS COILED. THE CATHETER HAD TO BE REMOVED DUE TO BAD POSITIONING. - CATHETER N. 5 FR - ARGON BRAND, IS PRESENTING RESISTANCE TO GUIDE WIRE REMOVAL. GUIDE WIRE WAS REMOVED IN ONE PIECE, AFTER SEVERAL MANEUVERS"

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15403261 ↗
  • MalfunctionAug 18, 2022Fluid/Blood Leak; Material Rupture

    HOSPITALIZED PATIENT, DIAGNOSED WITH CHF, PERFORMED PICC PASSAGE ON (B)(6), ON (B)(6) WHEN TAKING MEDICATION, IT WAS OBSERVED THAT THE CATHETER WAS LEAKING, IT WAS OBSERVED THAT THE CATHETER WAS RUPTURED IN THE DISTAL THIRD IN THE FIRST CM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15251977 ↗

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Sources and updates

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