Approach G50790Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002507906), received between Oct 25, 2016 and Aug 19, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 8, 2024Open, Classified

   Affected device lots have labels that state the incorrect expiration dates.

   Z-0346-2025 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF OCCLUDED LEFT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES INVOLVING AN (B)(6) YEAR-OLD FEMALE, A "BURR" WAS FOUND ON AN APPROACH CTO MICROWIRE WIRE GUIDE. THE PHYSICIAN REPORTEDLY INSERTED THE WIRE THROUGH ANOTHER MANUFACTURER'S SIX FRENCH SLENDER SHEATH. AS THE WIRE WAS REMOVED AND WIPED DOWN, A BURR WAS FELT AT THE AREA OF TRANSITION BETWEEN THE TIP AND THE "STIFFER" PART OF THE WIRE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S GUIDE WIRE FOR COMPLETION OF THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906777 ↗
• MalfunctionApr 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PIECE OF WHITE THREAD WAS FOUND INSIDE THE UNOPENED APPROACH CTO MICROWIRE WIRE GUIDE PACKAGING. THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7426986 ↗
• MalfunctionOct 25, 2016Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERIPHERAL INTERVENTION OF THE LEFT SFA. DURING THE PROCEDURE THE WIRE GUIDE SNAPPED IN TWO, WHILE IN THE PATIENT. THUS, THE PHYSICIAN REMOVED THE PRODUCT. THERE WAS NOT ANY HARM TO THE PATIENT AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6054582 ↗