Soehendra Tannenbaum G21438Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002214385), received between Mar 28, 2019 and Mar 28, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

Recent adverse event reports

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

• MalfunctionMar 28, 2019Material Deformation; Material Deformation

  (B)(6) TRIED TO INSERT A PLASTIC STENT, BUT THE STRICTURE WAS TOO TIGHT. SO THE STENT WAS KINKED. (B)(6) USED SBDC AND HURRICANE BALLOON FOR DILATION. AFTER THAT, THE PLASTIC STENT WAS INSERTED AGAIN. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8459163 ↗
• MalfunctionMar 28, 2019Material Deformation; Material Deformation

  (B)(6) TRIED TO INSERT A PLASTIC STENT, BUT THE STRICTURE WAS TOO TIGHT. SO THE STENT WAS KINKED. (B)(6) USED SBDC AND HURRICANE BALLOON FOR DILATION. AFTER THAT, THE PLASTIC STENT WAS INSERTED AGAIN. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8459102 ↗