Zilver PTX G38488Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002384887), received between Dec 21, 2016 and Mar 3, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Improper or Incorrect Procedure or Method

  AS REPORTED VIA EMAIL: "ONE OF MY PHYSICIANS USED ZILVER PTX DURING A PROCEDURE LAST WEEK, AND THE STENT MOVED DURING DEPLOYMENT. THE PHYSICIAN IS A VASCULAR SURGEON WHO IS NOT VERY EXPERIENCED WITH ENDOVASCULAR PROCEDURES. IT WAS HIS FIRST TIME USING ZILVER PTX. AN INTEGRATED ACCESS APPROACH WAS DONE. THE PATIENT WAS ELDERLY AND HAD SEVERE PERIPHERAL ARTERIAL DISEASE. CROSSING THE LESION WAS CHALLENGING, AS THE VESSEL WAS HIGHLY STENOTIC AND CALCIFIED. BECAUSE THE ACCESS WAS INTEGRATED AND POSITIONED ON THE OPPOSITE SIDE OF THE TABLE, THE DR WAS WORKING IN AN UP-AND-OVER POSITION BUT OUTSIDE OF THE PATIENT. AT THE TIME OF STENT DEPLOYMENT, THE SYSTEM WASN¿T STABILIZED PROPERLY AND THE STENT MOVED. AFTER DISCUSSION WITH COLLEAGUES, IT SEEMS THAT IT IS A USER ERROR." WHAT WAS THE DATE OF THE OCCURRENCE? FEBRUARY 2ND. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO. USAGE OF PRODUCT: INITIAL USE OF DEVICE. IS THE DEVICE AVAILABLE FOR RETURN? NO DID THE PATIENT REQUIRE ANY ADDITIONAL INTERVENTIONS/PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT? NO WERE BOTH OF THOSE DEVICES USED IN THE SAME PATIENT? YES WHAT WAS THE ACCESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495519 ↗
• InjuryOct 7, 2024Off-Label Use; Off-Label Use

  PHYSICIAN WAS ATTEMPTING TO PLACE A 7MM/80MM ZILVER PTX IN A PATIENT¿S TRANSVERSE SINUS (OFF OF IFU). WHEN SCROLLING THE THUMB WHEEL BACK TO DEPLOY THE STENT THE WHEEL STOPPED TURNING LEAVING HALF OF THE STENT DEPLOYED AND HALF OF THE STENT UNDEPLOYED. I WAS CALLED AND WITH THE SITUATION DESCRIBED I INSTRUCTED THEM TO TAKE APART THE HANDLE AND PULL ON THE WIRE INSIDE TO FINISH DEPLOYING THE STENT. AFTER THAT DID NOT WORK, THEY FACETIMED ME AND I SAW THAT THE SHEATH LOOKED TO BE SEVERED. THAT WAS UNKNOWN BEFORE I INSTRUCTED THEM TO PULL THE WIRE INSIDE OF THE HANDLE. THEY ASKED ME TO COME IN TO TRY TO HELP. WHILE THIRTY MINUTES OUT FROM THE HOSPITAL I ASKED FOR AN UPDATE, AND THEY SAID VASCULAR SURGERY CAME BY AND PULLED IT OUT. THE SHEATH CAME OUT WITH ALL THE PIECES ATTACHED BUT BROKE THE STENT. HALF OF THE STENT IS RETAINED IN THE PATIENT WITH NO ISSUE AS OF THIS MOMENT. WHEN I LOOKED AT THE DEVICE, THE OUTER SHEATH WAS BROKEN, THE INNER PIECE THAT RETRACTS WAS BROKEN AND UNWOUND, AND THE NOSE CONE WAS STILL ATTACHED WITH PIECES OF THE BROKEN STENT. THEY HAVE THE DEVICE TO SEND BACK BUT I WAS TOLD THE HOSPITAL MUST LOOK AT THE DEVICE FIRST BEFORE IT¿S TURNED OVER TO ME. I SAID IT

  Patient problems: Foreign Body In Patient

  MAUDE report 20392816 ↗
• InjuryOct 3, 2024Off-Label Use; Off-Label Use

  ACCORDING TO THE INITIAL REPORTER, THE PHYSICIAN WAS ATTEMPTING TO PLACE A 7MM/80MM ZILVER PTX IN A PATIENT¿S TRANSVERSE SINUS (OFF OF IFU). WHEN SCROLLING THE THUMB WHEEL BACK TO DEPLOY THE STENT THE WHEEL STOPPED TURNING LEAVING HALF OF THE STENT DEPLOYED AND HALF OF THE STENT UNDEPLOYED. I WAS CALLED AND WITH THE SITUATION DESCRIBED I INSTRUCTED THEM TO TAKE APART THE HANDLE AND PULL ON THE WIRE INSIDE TO FINISH DEPLOYING THE STENT. AFTER THAT DID NOT WORK, THEY FACETIMED ME AND I SAW THAT THE SHEATH LOOKED TO BE SEVERED. THAT WAS UNKNOWN BEFORE I INSTRUCTED THEM TO PULL THE WIRE INSIDE OF THE HANDLE. THEY ASKED ME TO COME IN TO TRY TO HELP. WHILE THIRTY MINUTES OUT FROM THE HOSPITAL I ASKED FOR AN UPDATE, AND THEY SAID VASCULAR SURGERY CAME BY AND PULLED IT OUT. THE SHEATH CAME OUT WITH ALL THE PIECES ATTACHED BUT BROKE THE STENT. HALF OF THE STENT IS RETAINED IN THE PATIENT WITH NO ISSUE AS OF THIS MOMENT. WHEN I LOOKED AT THE DEVICE, THE OUTER SHEATH WAS BROKEN, THE INNER PIECE THAT RETRACTS WAS BROKEN AND UNWOUND, AND THE NOSE CONE WAS STILL ATTACHED WITH PIECES OF THE BROKEN STENT. THEY HAVE THE DEVICE TO SEND BACK BUT I WAS TOLD THE HOSPITAL MUST LOOK AT THE DEVICE FIRST B

  Patient problems: Foreign Body In Patient

  MAUDE report 20358219 ↗
• MalfunctionJun 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER MEDWATCH FORM: PATIENT UNDERWENT DIAGNOSTIC ARTERIOGRAM AND TRANSCATHETER INTERVENTION; FIRST STENT WAS DEPLOYED (PR 396544 LOT C1741457), AND MD REQUESTED AN ADDITIONAL STENT. PRIOR TO PLACEMENT, IT WAS DISCOVERED THE DATE ON THE STENT PACKAGING WAS EXPIRED (B)(6)2022. (PR (B)(6) LOT C1769805) DATE OF IMPLANT: (B)(6)2022. PATIENT OUTCOME: N/A - OCCURRENCE WAS DISCOVERED PRIOR TO PATIENT CONTACT. SG (B)(6)2023. PATIENT/EVENT INFO - NOTES: PLEASE PROVIDE THE ORIGINATOR A LIST OF ANY ADDITIONAL MANUFACTURER QUESTIONS REQUIRED FOR INVESTIGATION. SG (B)(6)2023 THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON (B)(6)2023. SG (B)(6)2023 IN THE SECTION ¿DESCRIBE EVENT¿ THE STATEMENT ¿FIRST STENT WAS DEPLOYED, AND MD REQUESTED AN ADDITIONAL STENT. PRIOR TO PLACEMENT, IT WAS DISCOVERED THE DATE ON THE STENT PACKAGING WAS EXPIRED (B)(6)2022.¿ WAS G38489 ¿ LOT C1741457 THE 1ST STENT PLACED? IF SO WAS IT REMOVED DUE TO THE EXPIRATION DATE, OR WAS IT JUST A STENT THAT YOU HAD ON HAND AND NOT USED? ALSO PLEASE CONFIRM THAT THE SECOND EXPIRED STENT WAS NOT USED ON THE PATIENT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049716 ↗
• MalfunctionJul 8, 2021Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 07-APR-2023

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133733 ↗
• InjuryJun 30, 2021Material Deformation; Material Deformation

  ACCORDING TO THE INITIAL REPORTER: "DEVICE BUNCHED UP IN THE CENTER DURING DEPLOYMENT. USER WAS ABLE TO FULLY DEPLOY IT AND DIDN'T NOTICE ISSUE UNTIL AFTER DEPLOYMENT. THEY WERE ABLE TO BALLOON IT TO RE-EXPAND IT (IN DIAMETER), BUT MAY HAVE TO BRING PATIENT BACK TO CHECK IT AND POSSIBLY EXTEND IT AS IT IS STILL SHORTENED (LOOKS LIKE ABOUT A 60 INSTEAD OF AN 80). LONG OCCLUSION OF THE SFA. PICTURES AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091596 ↗
• MalfunctionApr 23, 2020Expiration Date Error; Expiration Date Error

  AS REPORTED TO CUSTOMER RELATIONS PER VERBAL DISCUSSION WITH THE DISTRICT MANAGER: PATIENT UNDERWENT A PROCEDURE IN WHICH THE ZILVER PTX 35 DRUG-ELUTING STENT, G38488, WAS USED. THE DEVICE WAS IMPLANTED AS EXPECTED WITH NO DIFFICULTIES. THE MEDICAL STAFF NOTED AFTER PROCEDURE WAS COMPLETE THAT THE DEVICE WAS EXPIRED BY 8 DAYS. DUE TO THIS THE FACILITY WANTED TO REPORT IT TO THE MANUFACTURE FOR AWARENESS. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. 2. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. 3. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 4. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 5. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9991394 ↗
• MalfunctionOct 25, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  REPORTED BY THE DM VIA PHONE CALL- DURING THE PROCEDURE BOTH STENTS DID NOT DEPLOY EVENLY. THEY DEPLOYED FULLY, BUT WERE CRUNCHED UP. BOTH STENTS ARE IMPLANTED IN THE PATIENT. 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 SHORTENING OR COMPRESSION DURING DEPLOYMENT' . NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9237227 ↗
• MalfunctionOct 8, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  REPORTED BY PHONE CALL FROM THE DM- WHEN ATTEMPTING TO PLACE THE FIRST STENT, THE STENT WOULD NOT GO THROUGH THE LESION BUT THE SECOND STENT WENT PAST THE LESION AND WAS ABLE TO CROSS. IT IS BELIEVED SOMETHING IS WRONG WITH THE DELIVERY SYSTEM OF THE FIRST STENT. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. FROM THE INITIAL INFORMATION RECEIVED, THIS EVENT WAS CAUTIOUSLY MADE REPORTABLE BASED ON THE PRECEDENCE IN PLACE FOR THIS DEVICE OF 'THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿. HOWEVER, WHEN THE RETURNED DEVICE WAS RECEIVED IT WAS CONFIRMED DURING THE LAB EVALUATION THAT THIS MALFUNCTION DID NOT OCCUR. THE FOLLOWING FAILURE HAS BEEN CONFIRMED: "RETRACTION SHEATH CANNOT REACH TARGET SITE". OVERALL RISK ASSESSED AS CATEGORY IIA (LOW). NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9165125 ↗
• MalfunctionJul 25, 2018Material Deformation; Material Deformation

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT. THIS FILE ADDRESSES THE FIRST STENT IMPLANTED WHICH WAS DAMAGED BY THE SECOND STENT: AS REPORTED TO CUSTOMER RELATIONS: "CAUGHT PROXIMAL EDGE WITH A SUBSEQUENT STENT AND FOLDED THE 6X140 IN ON ITSELF. HAD TO REMOVE THE SUBSEQUENT SYSTEM AND HAD TROUBLE GETTING CATHETER PAST OVERLAPPED SEGMENT TO RETRIEVE AN EMBOLIC FILTER. EVENTUALLY ABLE TO RETRIEVE FILTER AND BALLOONED THE FOLDED IN SEGMENT OF THE INITIAL PTX. AT THAT POINT, PLACED LONGER, SUBSEQUENT STENT THROUGH THAT END WITH GOOD ANGIOGRAPHIC RESULTS." DM BELIEVES THIS MIGHT BE A WIRE-GUIDE COMPATIBILITY ISSUE--WORKING ON .014 WIRE WITH .035 STENT, SO THE MISMATCH MIGHT BE THE PROBLEM. NOTHING AVAILABLE FOR RETURN (FIRST DEVICE REMAINS IN PATIENT, SECOND DEVICE DISCARDED)." ADDITIONAL INFORMATION PROVIDED BY DM ON 05JUL2018: "(CAN YOU CONFIRM IF THE STENT FRACTURED AT ALL WHEN IT CRUMPLED?) I CANNOT CONFIRM STENT FRACTURE. IT DID NOT APPEAR TO FRACTURE THOUGH."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7718490 ↗
• MalfunctionAug 22, 2017Difficult to Remove; Difficult to Remove

  THIS INITIAL REPORT IS BEING SUBMITTED DUE TO THE MALFUNCTION PRECEDENCE: "DELIVERY SYSTEM CANNOT BE WITHDRAWN". THIS REPORT FORMS PART OF RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY. STENT CATHETER WAS FLUSHED AND PREPPED ACCORDING TO IFU, STENT CATHETER TRACKED INTO THE BODY FINE WITH NO RESISTANCE. AFTER STENT WAS DEPLOYED, WITHOUT ERROR, STENT CATHETER BECAME "STUCK" ON THE WIRE. STENT CATHETER AND WIRE WERE THEN REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6810553 ↗
• MalfunctionJul 13, 2017Delivery System Failure; Delivery System Failure

  THIS FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE A ROOT CAUSE FOR THIS COMPLAINT ISSUE. INITIAL REPORT DETAILS: STENT CATHETER WAS FLUSHED AND PREPPED ACCORDING TO IFU, STENT CATHETER TRACKED INTO THE BODY FINE WITH NO RESISTANCE. AFTER STENT WAS DEPLOYED, WITHOUT ERROR, STENT CATHETER BECAME "STUCK" ON THE WIRE. STENT CATHETER AND WIRE WERE THEN REMOVED. ON EVALUATION OF THE COMPLAINT DEVICE ON 15-JUL-17 IT WAS OBSERVED THAT THE RETRACTION WIRE HAD SEPARATED FROM THE STENT RETRACTION SHEATH. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'RETRACTION WIRE SEPARATES FROM RETRACTION SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710717 ↗
• MalfunctionJun 1, 2017Stretched; Stretched

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: AS REPORTED TO CUSTOMER RELATIONS: "DURING THE PROCEDURE IT APPEARED THE STENT HAD ELONGATED. THE STENT SEEMS TO MEASURE 9.5MM INSTEAD OF 8MM. THE PHYSICIAN PUT AN 80 BALLOON IN AND CAME UP SHORT. THE STENT LANDED IN A GOOD SPOT AND THE PROCEDURE WENT WELL. PATIENT WAS RELEASED TO GO HOME."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6604121 ↗
• InjuryDec 21, 2016Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE UPDATE TO THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THE FACILITY PLACED A ZILVER PTX 7X120 WITH NO INCIDENT. THE FACILITY WENT TO OVERLAP WITH A SECOND ZILVER PTX 7X80 IN THE RIGHT SFA, DISTAL TO MID-LESION. APPROXIMATELY 40 MM'S OF THE STENT WAS DEPLOYED. AT THAT POINT THE THUMB WHEEL SYSTEM BROKE. THE PHYSICIAN ASKED FOR THE DM TO BE CALLED AND THE ZILVER PRODUCT MANAGER WAS CALLED. WHILE THEY WERE ON THE PHONE SPEAKING WITH OUR COOK REPRESENTATIVES, THE PHYSICIAN ATTEMPTED TO PULL THE ENTIRE DELIVERY SYSTEM (WITH THE STENT) OUT OF THE PATIENT. THE DOCTOR WAS ABLE TO REMOVE THE DELIVERY SYSTEM AND THE STENT, BUT APPROXIMATELY 20MM'S BROKE OFF AND WAS LEFT IN THE PATIENT'S COMMON ILIAC. THE BROKEN PORTION OF THE DEVICE IS STILL INSIDE THE PATIENT. THE PATIENT EMBOLIZED THE LOWER LEG AND WAS PLACED ON A TPA DRIP AND WILL BE BROUGHT BACK TO THE LAB IN THE AFTERNOON FOR RE-EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6192615 ↗