Zilver PTX G38495Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002384955), received between Mar 6, 2019 and Nov 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• MalfunctionNov 17, 2022Off-Label Use; Difficult or Delayed Activation; Off-Label Use; Difficult or Delayed Activation

  PER EMAIL FROM DM: PRODUCT MALFUNCTION AFTER THE STENT WAS DEPLOYED IN THE LEFT BRACHIAL ARTERY, THE DEPLOYMENT MECHANISM WOULD COME OFF THE WIRE. THE DEVICE GOT STUCK AND (B)(6) HAD TO TAKE OUT THE WIRE AND DEPLOYMENT MECHANISM TOGETHER. (B)(6) INSERTED A 180CM GUIDEWIRE TO COMPLETE THE CASE. THERE WERE NO ADVERSE EVENTS AND THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814207 ↗
• MalfunctionMar 6, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING DEVICE EVALUATION. THERE ARE THREE FILES RELATED TO THIS INCIDENT, THIS FILE WAS CREATED TO CAPTURE THE THIRD DEVICE. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿. AS REPORTED TO CUSTOMER RELATIONS, "PRODUCTS FAILED TO DEPLOY CORRECTLY. DEPLOYMENT ISSUE. COAXIAL SYSTEM DID NOT MOVED SEEM VERY TIGHT WHILE SCROLLING BACK. WHILE PULLING FIRST SYSTEM OUT STENT STARTED COMING OUT OF CATHETER. PATIENT WAS OK. A STENT WAS FRACTURE AND BROKE AND LEFT IN PATIENT, DOCTOR ANGIOPLASTIED STENT TO WALL IN COMMON FEMORAL. NO ADVERSE EFFECTS. THE SECOND AND THIRD DEVICE FELT TIGHTNESS UPON SCROLLING BACK, DECIDED TO REMOVE DEVICE COMPLETELY. SAFELY REMOVED DEVICE, PATIENT FINE, NO ADDITIONAL PRODUCTS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8395048 ↗