Forté® AXP Access Sheath B7296Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915113551), received between Oct 27, 2021 and Oct 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unraveled Material” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2021Unraveled Material; Unraveled Material

  EVENT DESCRIPTION PER CUSTOMER EXPERIENCE REPORT: "WHEN THE DEVICE WAS TO BE INSERTED OVER THE GUIDE WIRE, THE SHEATH BEGAN TO UNWIND IN A SPIRAL SHAPE." ADDITIONAL INFORMATION RECEIVED VIA EMAIL 21OCT2021 FROM [NAME], AMETECH REGULATORY AFFAIRS AND QUALITY ASSURANCE: PHOTO OF PRODUCT ATTACHED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL (B)(6) 2021 FROM [NAME], AMETECH REGULATORY AFFAIRS AND QUALITY ASSURANCE: IT IS UNKNOWN WHAT PROCEDURE WAS PERFORMED. IT IS UNKNOWN WHAT OTHER INSTRUMENTATION WAS USED IN THE PROCEDURE. THE PHYSICIAN COMPLETED THE CASE WITH ANOTHER SHEATH FROM ANOTHER MANUFACTURER. THE SURGEON WAS NOT ABLE TO FIX THE SPIRAL SHAPE. IF IS UNKNOWN HOW THE SURGEON REMOVED THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704477 ↗