Intracath 384902Recalls & reported problems
Argon Medical Devices, Inc. · Intracath 22ga x 8" I.V. Catheter/Needle Unit w/ Wire Stylet (19ga x 2" Needle) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333210121), received between Dec 20, 2021 and May 3, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Migration or Expulsion of Device1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2024Break; Break
HELLO, WE RECENTLY HAD AN INTRACATH FAILURE WHERE THAT CATHETER BROKE OFF WHILE PLACED IN A PATIENT. I WAS WONDERING IF YOU HAVE HAD ANY DEFECTS REPORTED WITH YOUR 22G X8" INTRACATHS (REF#384902). I WOULD APPRECIATE THE OPPORTUNITY TO DISCUSS THIS WITH A QUALITY ASSURANCE REPRESENTATIVE. EMAIL IS THE BEST METHOD OF CONTACT. ADDITIONAL INFORMATION RECEIVED INDICATING REMAINING PORTION MIGRATED TO THE PATIENT'S LUNG TISSUE. TRANSFERRED PATIENT TO ANOTHER FACILITY. UNSURE OF OUTCOME AT THIS POINT. A NEW INTRACATH WAS NOT PLACED. LOT NUMBER: 11552911 (PACKAGING NOT AVAILABLE AT TIME OF INCIDENT BUT THIS IS THE ONLY LOT NUMBER WE HAVE CURRENTLY IN THE HOSPITAL.
Patient problems: Foreign Body In Patient
MAUDE report 19244139 ↗InjuryDec 20, 2021Break; Migration or Expulsion of Device
WE HAVE BEEN USING THE INTRACATH 22G X 8'' CATHETER/NEEDLE UNIT WITH WIRE STYLET (19GA X 2'' NEEDLE). WE USE THESE ROUTINELY AND MANY PATIENTS (DOGS AND CATS) HAVE THESE PLACED DURING HOSPITALIZATION. OUR TECHNICAL STAFF IS VERY FAMILIAR PLACING THEM. WE HAVE HAD 3 OF THESE CATHETERS IN THE PAST FEW MONTHS BREAK OFF WHILE IN PATIENTS. IT SEEMS THEY ARE BEING PLACED USING PROPER TECHNIQUE, AND ARE NOT BEING REMOVED WITH EXCESSIVE FORCE. MOST RECENTLY, WE HAD A CAT WITH ONE IN WHICH HALF OF THE CATHETER BROKE OFF AND A LARGE PIECE TRAVELED TO THE HEART REQUIRING REFERRAL FOR REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 13043163 ↗
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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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