Guidewire SGW-019-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841268100862), received between Mar 10, 2023 and May 27, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 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.

• MalfunctionMay 27, 2025Material Integrity Problem; Material Integrity Problem

  I WAS PLACING A PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE, AND I HAD GAINED ACCESS AND USED MY GUIDEWIRE TO MAINTAIN ACCESS IN THE VEIN. AFTER I INTRODUCED THE VEIN, I REMOVED MY GUIDEWIRE, AND I NOTICED THAT THE WIRE WAS NOT INTACT AT THE END. I WAS ABLE TO SEE THAT THE WIRE WAS BUNCHED BUT THE TIP WAS STILL HOLDING. WHEN I PLACED THE LINE, IT WAS COMPLETELY SMOOTH WITH NO THREADING ISSUES TO NOTE. THE LINE THREADED WITHOUT ISSUES, AND I INFORMED THE NP [NURSE PRACTITIONER] AND NOTHING WAS NOTED ON THE CHEST X-RAY. THE LINE WAS PLACED WITHOUT ISSUES, AND I SAVED THE WIRE AND THE PACKAGING OF THE WIRE BUT NOT THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092144 ↗
• MalfunctionMar 10, 2023Solder Joint Fracture; Solder Joint Fracture

  AS RECEIVED BY THE CUSTOMER FROM END USER (THIS PICC RN WAS PLACING A PICC LINE IN PATIENT'S RIGHT UPPER ARM (BRACHIAL VEIN). ACCESSED VESSEL WITH 24G ANGIOCATH, HAD BRISK BLOOD RETURN, PLACED AN .014 NITINOL GUIDEWIRE THROUGH ANGIOCATH INTO VESSEL. NITINOL GUIDEWIRE ADVANCED 10 CM WITHOUT ANY DIFFICULTY OR RESISTANCE. DILATOR WAS PLACED OVER THE GUIDEWIRE AND ADVANCED INTO THE VESSEL WITHOUT ANY DIFFICULTIES. PICC LINE WAS THEN PLACED OVER THE GUIDEWIRE THROUGH THE DILATOR. WAS ONLY ABLE TO ADVANCE PICC LINE ABOUT 8 CM AND THEN FELT RESISTANCE. OBTAINED CXR. SHOWED PICC LINE IN SUBCLAVIAN VEIN CURLED BACK ON ITSELF SLIGHTLY. COULD NOT STRAIGHTEN PICC OR GUIDEWIRE OUT. DECISION MADE TO REMOVE PICC AND GUIDEWIRE AND TO ATTEMPT 0.14 GUIDEWIRE INSTEAD. UPON REMOVING GUIDEWIRE, IT WAS NOTED THAT THE GUIDEWIRE WAS UNRAVELING).

  Patient problems: Vascular Dissection

  MAUDE report 16524841 ↗