First PICC™ D/L Peripherally Inserted Central Catheter 384159Recalls & reported problems
Argon Medical Devices, Inc. · First PICC™ D/L Peripherally Inserted Central Catheter 16ga (5F) 1.75mm x 65cm · Class 2 · Implant
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 00886333209705), received between Nov 17, 2020 and Feb 10, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Perforation1
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.
MalfunctionFeb 10, 2021Material Perforation
"THE PICC 5FR CATHETER WAS PASSED, BUT AT THE END OF INSERTION IT WAS OBSERVED THAT THE EXTENSION NEAR THE OVAL DISC WAS PERFORATED "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11310620 ↗MalfunctionNov 17, 2020Fluid/Blood Leak
PICC CATHETER PRESENTED LEAKAGE AT THE 9CM LENGTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10852829 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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