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Forté® AxP Access Sheath B7016Recalls & reported problems

Applied Medical Resources Corporation · Ureteral Stent Placement Set · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915113148), received between Mar 15, 2022 and Mar 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (2 reports).

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

Device problems

  • Unraveled Material2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionMar 15, 2022Unraveled Material; Unraveled Material

    PROCEDURE PERFORMED: LASER FOR STONES. COMPLAINT 1 OF 2: (B)(4). COMPLAINT 2 OF 2: (B)(4). EVENT DESCRIPTION: BOTH THESE TWO AXH SHEATH WAS USED DURING A PROCEDURE. 1. OUTER PIECE SPIRRALE. 2 KINKED BELOW. ADDITIONAL INFORMATION PROVIDED 15FEB2022 VIA EMAIL FROM [NAME] NON-CONFORMANCE REPORT: PRODUCT KINKED, BROKEN, SPIRALLED. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: NI.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13772638 ↗
  • MalfunctionMar 15, 2022Unraveled Material; Unraveled Material

    PROCEDURE PERFORMED: LASER FOR STONES. COMPLAINT 1 OF 2:(B)(4) . COMPLAINT 2 OF 2: (B)(4)- MFR 2027111-2022-00468. EVENT DESCRIPTION: BOTH THESE TWO AXH SHEATH WAS USED DURING A PROCEDURE. 1. OUTER PIECE SPIRRALE. 2 KINKED BELOW. ADDITIONAL INFORMATION PROVIDED 15FEB2022 VIA EMAIL FROM [NAME] NON-CONFORMANCE REPORT: PRODUCT KINKED, BROKEN, SPIRALLED. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL ON 10-MAR-2022: NO PICTURES WERE TAKEN BEFORE THE DEVICES WERE SENT TO THE MANUFACTURER. BOTH ACCESS SHEATHS KINKED DURING REMOVAL AND ONE SPIRALLED OFF DURING THE PROCEDURE, AS YOU CAN SEE IN THE RETURNED PRODUCT. TWO OTHER ACCESS SHEATHS WERE USED AND WORKED PERFECTLY. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: TWO OTHER ACCESS SHEATHS WERE USED AND WORKED PERFECTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13772627 ↗

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Sources and updates

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