Zimmon G21781Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002217812), received between Jun 19, 2019 and Jun 19, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 16, 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.

• MalfunctionJun 19, 2019Material Deformation; Material Deformation

  DRAINAGE OF A PANCREATIC PSEUDOCYST, SETTING UP A ZEBD-10-4 STENT BUT NO PIGTAIL RECTIFIER IN THE PACKAGE. PIGTAIL PUT RIGHT BY THE NURSE BUT THE STENT IS PLICATION SETTING UP ANOTHER STENT. 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 8711755 ↗