Zimmon G21369Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002213692), received between Mar 21, 2019 and Jul 4, 2019 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2019Fracture; Material Deformation; Fracture; Material Deformation

  THE PIGTAIL CURVE BROKE OFF BUT IS STILL ATTACHED. "AS PER COMPLAINT FORM": THE PIGTAIL CURVE OF THE STENTS IS BROKEN BUT STILL ATTACHED. IN ONE CASE THEY REALIZED IT ALREADY OUTSIDE OF THE SCOPE IN THE OTHER CASE THEY REALIZED IT AFTER IMPLANTATION OF THE STENT AND DECIDED TO KEEP THE STENT IN PLACE. PLEASE NOT : NOTHING IS DETACHED IN THE BODY! 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'. AND '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 8762500 ↗
• InjuryJul 1, 2019Break; Break

  THE PIGTAIL CURVE BROKE OFF BUT IS STILL ATTACHED. "AS PER COMPLAINT FORM": THE PIGTAIL CURVE OF THE STENTS IS BROKEN BUT STILL ATTACHED. IN ONE CASE THEY REALIZED IT ALREADY OUTSIDE OF THE SCOPE IN THE OTHER CASE THEY REALIZED IT AFTER IMPLANTATION OF THE STENT AND DECIDED TO KEEP THE STENT IN PLACE. PLEASE NOTE : NOTHING IS DETACHED IN THE BODY! FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 BASED ON THE ASSUMPTION THAT AN ADDITIONAL PROCEDURE WILL BE REQUIRED TO REMOVE THE BROKEN STENT ALSO 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

  MAUDE report 8748503 ↗
• InjuryMar 21, 2019Difficult to Remove; Difficult to Remove

  THERE SEEM TO BE REPEATEDLY MECHANICALLY INDUCED MACERATION OF THE MUCOUS MEMBRANE OF THE STOMACH OR OESOPHAGUS. POSSIBLE CAUSE SEEMS TO BE THE RIGIDITY OF THE MATERIAL SPECIALLY OF THE 8 FR. DRAINAGE STENTS, AS THIS HAS NOT HAPPENED WITH OTHER SIZES FROM THE SORTIMENT. "AS PER COMPLAINT FORM": THE PROCEDURE IN QUESTION WAS THE REMOVAL OF A 8 F DOUBLE PIGTAIL STENT, THAT HAD BEEN PLACED IN THE BILIARY DUCT. ACCORDING TO THE CUSTOMER, THE STENT WAS SO RIGID AND INFLEXIBLE THAT WHILE WITHDRAWING IT CAUSED A SCRATCH IN THE ATRUM OF THE STOMACH WHICH CAUSED BLEEDING, AND FURTHERMORE LEFT A VISIBLE PATH ON THE MUCOSA IN STOMACH AND ESOPHAGUS ON ITS WAY OUT. THE BLEEDING IN THE ATRUM WAS STOPPED BY USING 4 INSTINCT CLIPS. FDA MDR REPORTING REQUIRED, REPORTING REQUIRED BASED ON THE REQUIREMENT FOR A SURGICAL INTERVENTION AS "THE DAMAGE IN THE STOMACH (ANTRIUM) HAD TO BE CLIPPED WITH 4 CLIPS". NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. THE RISK IS NOT CONSIDERED TO BE 'REMOTE'.

  Patient problems: Tissue Damage

  MAUDE report 8440062 ↗