Approach G50786Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002507869), received between May 21, 2021 and May 21, 2021 — classified as 1 injury.

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

2 FDA recall records name this device's identifier, 2 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. Mar 5, 2026Open, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1775-2026 · Root cause: Incorrect or no expiration date · FDA record ↗

2. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2021Material Separation; Material Separation

  AS REPORTED, DURING AN ENDOVASCULAR PROCEDURE IN THE LOWER EXTREMITY BELOW THE KNEE, A APPROACH CTO MICROWIRE WIRE GUIDE FRACTURED. ACCESS WAS GAINED THROUGH THE RIGHT GROIN. THE TIP OF THE WIRE FRACTURED AND WAS LEFT IN THE PATIENT AS A FOREIGN BODY. THE PATIENT DID NOT HAVE CALCIFIED OR TORTUOUS ANATOMY. THE WIRE WAS NOTED TO HAVE KINKED INSIDE OF THE PATIENT. THE PHYSICIAN WAS ABLE TO USED A SNARE TO RETRIEVED THE FRACTURED PORTION OF THE DEVICE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11863162 ↗