Zimmon G24591Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002245914), received between Jun 13, 2019 and Jun 13, 2019 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2019Break; Break

  AS REPORTED TO CUSTOMER RELATIONS, "DEVICE WAS DEFECTIVE OUT OF PACKAGE. PLASTIC STENT WAS BROKEN UPON OPENING AND MISSING INTERNAL FLANGE (PICTURED). THE DEVICE DID NOT MAKE PATIENT CONTACT AND DID NOT CAUSE ANY HARM TO THE PATIENT. THE NURSE OPENED A NEW DEVICE TO USE INSTEAD OF THE DEFECTIVE DEVICE, AND COMPLETED THE PROCEDURE.". 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 FRACTURE'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8694574 ↗