Zilver PTX G38407Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002384078), received between Dec 20, 2023 and Dec 2, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Difficult or Delayed Activation; Defective Device; Difficult or Delayed Activation; Defective Device

  SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION ON 3 JUL 2025 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817539 ↗
• InjuryOct 10, 2024Structural Problem; Structural Problem

  PER REP - 04DEC2023 - THEY HAD ACCESS ON THE RIGHT GROIN. THE PATIENT ALREADY HAD A LEFT FEM POP BYPASS AND ALREADY HAD BILATERAL KISSING ILIAC ARTERY STENTS. THEY WENT UP AND OVER WITH A 6 FR 655 HIGH FLEX ANSEL SHEATH. THEY USED A SECOND HIGH FLEX ANSEL SHEATH BECAUSE THE FIRST ONE GOT CRINKLED (B)(4) BUT IT WORKED. THEY WENT TO USE THE SECOND AND IT GOT RIPPED IN HALF (B)(4). IT MAY HAVE GOTTEN SNAGGED ON ONE OF THE PRIOR PLACED STENTS. WHEN THEY WERE PULLING BACK ON THE SHEATH, THEY REALIZED IT WAS PULLED IN HALF. THE DISTAL MARKER ON THE STENT BROKE OFF (B)(4) ALONG WITH THE DISTAL PART OF THE HIGH FLEX ANSEL SHEATH. THEY CUT DOWN ON THE LEFT GROIN TO PULL OUT THE FOREIGN BODIES FROM THE SHEATH AND THE DISTAL MARKER OF THE STENT. THE REP CONFIRMED THAT FOREIGN BODIES FROM THE PRODUCTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THIS COMPLAINT CAPTURES THE DEVICE COMPLAINT OF ¿THE DISTAL MARKER BROKE OFF¿. WAS PATIENT HOSPITALIZED - ALREADY IN-PATIENT AND IT WAS AN ADD ON DELAY OR ADDITIONAL PROCEDURE - SURGERY TO REMOVE FOREIGN BODIES ADDTL PROCEDURE DUE TO PRODUCT - SURGERY TO REMOVE FOREIGN BODIES ADVERSE EFFECTS ON PATIENT -NONE OTHER THAN CUT DOWN ADV EFFECTS DUE TO PRODUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416457 ↗
• InjuryDec 21, 2023Off-Label Use; Off-Label Use

  PER REP - 04DEC2023 - THEY HAD ACCESS ON THE RIGHT GROIN. THE PATIENT ALREADY HAD A LEFT FEM POP BYPASS AND ALREADY HAD BILATERAL KISSING ILIAC ARTERY STENTS. THEY WENT UP AND OVER WITH A 6 FR 655 HIGH FLEX ANSEL SHEATH. THEY USED A SECOND HIGH FLEX ANSEL SHEATH BECAUSE THE FIRST ONE GOT CRINKLED (B)(4) BUT IT WORKED. THEY WENT TO USE THE SECOND AND IT GOT RIPPED IN HALF (B)(4). IT MAY HAVE GOTTEN SNAGGED ON ONE OF THE PRIOR PLACED STENTS. WHEN THEY WERE PULLING BACK ON THE SHEATH THEY REALIZED IT WAS PULLED IN HALF. THE DISTAL MARKER ON THE STENT BROKE OFF (B)(4) ALONG WITH THE DISTAL PART OF THE HIGH FLEX ANSEL SHEATH. THEY CUT DOWN ON THE LEFT GROIN TO PULL OUT THE FOREIGN BODIES FROM THE SHEATH AND THE DISTAL MARKER OF THE STENT. THE REP CONFIRMED THAT FOREIGN BODIES FROM THE PRODUCTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. WAS PATIENT HOSPITALIZED - ALREADY IN-PATIENT AND IT WAS AN ADD ON DELAY OR ADDITIONAL PROCEDURE - SURGERY TO REMOVE FOREIGN BODIES ADDTL PROCEDURE DUE TO PRODUCT - SURGERY TO REMOVE FOREIGN BODIES ADVERSE EFFECTS ON PATIENT -NONE OTHER THAN CUT DOWN ADV EFFECTS DUE TO PRODUCT -NONE OTHER THAN CUT DOWN PREFIX ZIV6-PTX/ZISV6-PTX 3.60 ARE IMAGES (E.G. ANGI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380568 ↗
• InjuryDec 20, 2023Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 26-JUL-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364437 ↗