Guidewire A395231Recalls & reported problems
Argon Medical Devices, Inc. · Guidewire 35/150/FC/PTFE/ST · Class 2
Data updated Oct 18, 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 00886333216215), received between Oct 11, 2023 and Oct 25, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Too Rigid or Stiff2
- Device Misassembled During Manufacturing /Shipping1
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.
MalfunctionOct 25, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff
DURING PROCEDURE, A PHYSICIAN STOPPED USING THE GUIDEWIRE AS THE GUIDEWIRE SOFT TIP(DISTAL TIP) WAS ABNORMALLY STIFFER THAN USUAL. THE PROCEDURE WAS COMPLETED BY USING AN ADDITIONALLY OPENED REPLACEMENT (A395231).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18003495 ↗MalfunctionOct 11, 2023Material Too Rigid or Stiff; Device Misassembled During Manufacturing /Shipping; Material Too Rigid or Stiff; Device Misassembled During Manufacturing /Shipping
DURING PROCEDURE, A PHYSICIAN STOPPED USING THE GUIDEWIRE AS THE GUIDEWIRE SOFT TIP(DISTAL TIP) WAS ABNORMALLY STIFFER THAN USUAL. A PHYSICIAN IS VERY CONCERN ABOUT THE ABNORMALLY STIFF TIP(DISTAL TIP) WHICH WAS SIMILAR STIFFNESS TO THE PROXIMAL STIFF TIP. -THE ABNORMALLY STIFF TIP(DISTAL TIP) CAN CAUSE SERIOUS INCIDENT SUCH AS CARDIAC PERFORATION ON CLINICAL USE. THE PROCEDURE WAS COMPLETED BY USING AN ADDITIONALLY OPENED REPLACEMENT((B)(6)).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17915064 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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