Approach G50787Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002507876), received between Jul 26, 2016 and May 13, 2019 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1776-2026 · Root cause: Incorrect or no expiration date · Recall details · 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 · Recall details · FDA record ↗

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 13, 2019Material Separation; Material Separation

  IT WAS REPORTED, A PATIENT OF UNKNOWN GENDER OR AGE, WAS UNDERGOING A PERIPHERAL ARTERY DISEASE (PAD) ANGIOPLASTY LEG PROCEDURE. TWO APPROACH CTO MICROWIRE WIRE GUIDES FROM DIFFERENT LOTS WERE USED AND BOTH TIPS STARTED TO UNRAVEL DURING ENTRY AND MANIPULATION THROUGH A .014 CXI CROSSING CATHETER. THE TIPS WERE STILL INTACT BUT PARTIALLY SEPARATED. RIGHT LEG FEMORAL WAS THE ACCESS POINT WHERE THE DEVICES WERE INTRODUCED . HEAVY CALCIFICATION WAS PRESENT IN VESSEL TO BE TREATED. A THIRD CTO WIRE WAS USED WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED WITH NO PATIENT ADVERSE EFFECT OR ADDITIONAL PROCEDURES REQUIRED. PLEASE SEE REPORT REFERENCE NUMBER 1820334-2019-01135 FOR THE OTHER DEVICE MENTIONED HERE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8604610 ↗
• MalfunctionJul 26, 2016Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING A PERIPHERAL PROCEDURE WHEN THE PHYSICIAN ADVANCED THE MICROWIRE WIRE GUIDE WITH THE SUPPORT CATHETER AND TORQUE DEVICE THROUGH THE SUPERFICIAL FEMORAL ARTERY HE ENCOUNTERED RESISTANCE. THIS OCCURRED WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE. ONCE THE WIRE WAS REMOVED, THE PHYSICIAN NOTICED THAT THE COATING HAD COME OFF OF THE WIRE. HOWEVER, IT DID NOT COME OFF INSIDE THE PATIENT, BUT INSIDE THE CATHETER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5821893 ↗