Wallstent H965180011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729203070), received between May 29, 2022 and Feb 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Peeled/Delaminated; Peeled/Delaminated

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: GUIDEWIRE WAS PLACED IN PATIENT HOWEVER WHEN LOADING DILATION BALLOON ONTO IT, THE WIRE COATING STRIPPED FROM THE INNER WIRE WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: GUIDEWIRE REMOVED AND NEW GUIDEWIRE WAS PLACED WHAT IS THE NEXT COURSE OF ACTION?: GUIDEWIRE REMOVED AND NEW GUIDEWIRE WAS PLACED PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS TIME OF THE EVENT: DURING PROCEDURE WHAT WAS THE OUTCOME OF THE PROCEDURE? PROCEDURE COMPLETED USING AN ALTERNATE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404762 ↗
• MalfunctionMay 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  EVENT DESCRIPTION: PLEASE PROVIDE A BRIEF SUMMARY OF THE EVENT THAT INCLUDES ANY ADDITIONAL DETAILS THAT YOU HAVE NOT ALREADY PROVIDED: NULL. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. REASON FOR UNSUCCESSFUL PROCEDURE: PATIENT HAD BOTH AN ESOPHAGEAL STRICTURE AND PYLORIC STRICTURE. ESOPHAGUS WAS DILATED BUT THERE WAS NOT ENOUGH FOR AN XP SCOPE OR DELIVERY CATHETER TO FIT. AXIOS WAS ADVANCED OTW AND IT STRIPED THE JACKET OFF THE GUIDEWIRE HALFWAY DOWN GETTING JAMMED. WAS THE PATIENT SEDATED WHEN THE PROCEDURE WAS CANCELLED?: YES. DEVICE 2 OF 2. EVENT DATE: (B)(6) 2022. (B)(4). ADDITIONAL INFORMATION - 18-MAY-2022: COULD YOU PLEASE PROVIDE ME A DHR REVIEW AND RISK REVIEW FOR THIS COMPLAINT? LOT NUMBERS ARE: 6713592, 6713583, 6560921. ADDITIONAL INFORMATION - 24-MAY-2022: WAS THERE ANY DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE? NO DAMAGE NOTED. WAS THERE ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING? NO. WAS THE PRODUCT INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL? YES. WILL THE DEVICE BE RETURNED FOR ANALYSIS? THE ACCOUNT THREW OUT THE WIRES. WHAT IS THE LOT# FOR THE DEVICE? WORKING WITH ACCOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14539066 ↗