Zimmon G21460Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002214606), received between Aug 24, 2018 and Mar 21, 2019 — classified as 2 malfunctions.

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

• MalfunctionMar 21, 2019Break; Break

  AFTER TAKING STONE THEN PUT ERBD, IT WAS FOUND THE SIDE PORT OF THE STENT WAS CRACKED 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" AND "STENT FRACTURE". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8440330 ↗
• MalfunctionAug 24, 2018Human-Device Interface Problem; Human-Device Interface Problem

  KINKING AT THE LEVEL OF ONE OF THE EXTREMITY OF THE DEVICE, PREVENTING THE SLIPPING ON OF THE WIRE, NEED TO USE ANOTHER STENT. INCIDENT NOT DECLARED TO THE ANSM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812132 ↗