Zilver PTX G38516Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002385167), received between May 19, 2017 and Aug 27, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER REP - (B)(6) 2025 - THEY HAD ACCESS ON RIGHT SIDE OF THE PATIENT AND WERE OVER THE BIFURCATION ATTEMPTING TO STENT THE LEFT LEG. DURING DEPLOYMENT, ROUGHLY TWO THIRDS OF THE STENT DEPLOYED AND ONE THIRD WAS STUCK IN THE DEPLOYMENT SYSTEM. THEY ENDED UP BREAKING OPEN THE HANDLE OF THE PTX AND ATTEMPTING TO DEPLOY THE REST OF STENT. THEY WERE ABLE TO GET THE PROXIMAL ONE THIRD OF THE STENT DEPLOYED BUT IT WAS INSIDE OF THE INTRODUCER SHEATH THAT WAS OVER THE BIFURCATION. THE CASE IS STILL GOING ON. THEY ARE PRESENTLY ATTEMPTING TO EXTRACT THE REST OF THE STENT FROM THE SHEATH. UPDATE FROM REP - (B)(6) 2025 - FROM THE PHYSICIAN THE DEVICE FAILED TO FULLY DEPLOY, AND AS THEY WERE TRYING TO BACK IT OUT, WHILE PARTIALLY DEPLOYED, IT GOT STUCK ON THE AORTIC BIFURCATION AND THEN BECAME DETACHED FROM THE DELIVERY SYSTEM COMPLETELY. THEY ENDED UP HAVE TO USED 3 MORE DEVICES TO ANCHOR IT IN PLACE. PT IS DOING FINE. OUTSIDE OF A SOMEWHERE STEEP AORTIC BI-FUR, NOTHING WAS OUT OF THE ORDINARY. I HAVE THE FAILED DEVICE IN QUESTION, AS I STOPPED BY TO PICK IT UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904252 ↗
• InjuryJul 8, 2025Off-Label Use; Activation, Positioning or Separation Problem; Off-Label Use; Activation, Positioning or Separation Problem

  PER REP - 10JUN2025 - THEY HAD ACCESS ON RIGHT SIDE OF THE PATIENT AND WERE OVER THE BIFURCATION ATTEMPTING TO STENT THE LEFT LEG. DURING DEPLOYMENT, ROUGHLY TWO THIRDS OF THE STENT DEPLOYED AND ONE THIRD WAS STUCK IN THE DEPLOYMENT SYSTEM. THEY ENDED UP BREAKING OPEN THE HANDLE OF THE PTX AND ATTEMPTING TO DEPLOY THE REST OF STENT. THEY WERE ABLE TO GET THE PROXIMAL ONE THIRD OF THE STENT DEPLOYED BUT IT WAS INSIDE OF THE INTRODUCER SHEATH THAT WAS OVER THE BIFURCATION. THE CASE IS STILL GOING ON. THEY ARE PRESENTLY ATTEMPTING TO EXTRACT THE REST OF THE STENT FROM THE SHEATH. UPDATE FROM REP - 16JUN2025 - FROM THE PHYSICIAN THE DEVICE FAILED TO FULLY DEPLOY, AND AS THEY WERE TRYING TO BACK IT OUT, WHILE PARTIALLY DEPLOYED, IT GOT STUCK ON THE AORTIC BIFURCATION, AND THEN BECAME DETACHED FROM THE DELIVERY SYSTEM COMPLETELY. THEY ENDED UP HAVE TO USED 3 MORE DEVICES TO ANCHOR IT IN PLACE. PT IS DOING FINE. OUTSIDE OF A SOMEWHERE STEEP AORTIC BI-FUR, NOTHING WAS OUT OF THE ORDINARY. I HAVE THE FAILED DEVICE IN QUESTION, AS I STOPPED BY TO PICK IT UP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22453444 ↗
• InjuryJun 27, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ACCORDING TO THE INITIAL REPORTER, FROM THE PHYSICIAN THE DEVICE FAILED TO FULLY DEPLOY, AND AS THEY WERE TRYING TO BACK IT OUT, WHILE PARTIALLY DEPLOYED, IT GOT STUCK ON THE AORTIC BIFURCATION AND THEN BECAME DETACHED FROM THE DELIVERY SYSTEM COMPLETELY. THEY ENDED UP HAVE TO USED 3 MORE DEVICES TO ANCHOR IT IN PLACE. PT IS DOING FINE. OUTSIDE OF A SOMEWHERE STEEP AORTIC BI-FUR, NOTHING WAS OUT OF THE ORDINARY. I HAVE THE FAILED DEVICE IN QUESTION, AS I STOPPED BY TO PICK IT UP. FURTHER INFORMATION PROVIDED - THEY HAD ACCESS ON RIGHT SIDE OF THE PATIENT AND WERE OVER THE BIFURCATION ATTEMPTING TO STENT THE LEFT LEG. DURING DEPLOYMENT, ROUGHLY TWO THIRDS OF THE STENT DEPLOYED AND ONE THIRD WAS STUCK IN THE DEPLOYMENT SYSTEM. THEY ENDED UP BREAKING OPEN THE HANDLE OF THE PTX AND ATTEMPTING TO DEPLOY THE REST OF STENT. THEY WERE ABLE TO GET THE PROXIMAL ONE THIRD OF THE STENT DEPLOYED BUT IT WAS INSIDE OF THE INTRODUCER SHEATH THAT WAS OVER THE BIFURCATION. THE CASE IS STILL GOING ON. THEY ARE PRESENTLY ATTEMPTING TO EXTRACT THE REST OF THE STENT FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345588 ↗
• MalfunctionDec 12, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS REPORT WAS SUBMITTED CONSERVATIVELY BASED ON LIMITED INFORMATION AND ASSUMPTION THAT THE 'THUMBWHEEL MALFUNCTIONED DURING DEPLOYMENT.' EVENT WAS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'THUMBWHEEL MALFUNCTIONS". HOWEVER, THE COMPLAINT DEVICE WAS EVALUATED ON 14-DEC-17 AND NO ISSUES WITH THE THUMBWHEEL WERE NOTED IN THE LABORATORY.. STENT WAS DEPLOYED ONCE TRIGGER WAS DEPRESSED, NO ISSUES. IT WAS CONFIRMED IT WAS THE FLLA THAT WAS SPINNING FREELY AND ROOT CAUSE WAS USER OVER TORQUED SYRINGE. THIS FAILURE MODE RECORDED IS NOT A REPORTABLE MALFUNCTION AND AS SUCH THIS REPORT IS RE-ASSESSED AND DOES NOT MEET THE REPORTING CRITERIA OF A MALFUNCTION. INITIAL REPORT DETAILS: THE WIRE WENT THROUGH THE INITIAL END HOLE, BUT IT WOULD NOT COME OUT THE BACK END HOLE OF THE CATHETER OF THE ZILVER STENT. THE FACILITY INDICATED THEY REPEATEDLY FLUSHED THE SYSTEM, TRIED TO PUT THE WIRE BACK IN, BUT THEY HEARD A AUDIBLE CRACK. ALSO, THE THUMBWHEEL ASSEMBLY STARTED TO SPIN AROUND THE CATHETER SYSTEM. AT THIS POINT , THE FACILITY STOPPED TRYING TO PREP THE DEVICE AND THAT'S WHEN THEY OPENED UP A NEW ONE TO COMPLETE THIS PROC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7107744 ↗
• InjuryMay 19, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ACCESS WAS THROUGH BRACHIAL ARTERY. DURING ADVANCEMENT TO THE SFA, THE STENT BEGAN TO DEPLOY BEFORE RELEASING THE SAFETY; DEVICE DEPLOYED IN AORTA. PATIENT WAS SENT TO SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 6577797 ↗