Zilver PTX G38481Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10827002384818), received between Aug 8, 2016 and Apr 3, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Improper or Incorrect Procedure or Method

  THE SHAFT WAS KINKED AND THEY WERE NOT ABLE TO ADVANCE A .018 WIRE TO EXIT THE TIP. THEY HAD TO USE ANOTHER G38481 TO FINISH THE PROCEDURE. IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? DID NOT GET INTO THE PATIENT, TRIED TO LOAD THE .018¿ WIRE THROUGH THE ZILVER PTX 6 MM X 100 MM OUTSIDE OF BODY WOULDN'T ADVANCE, THERE WAS A KINK IN SHAFT THE DRS. TRIED TO STRAIGHTEN IT OUT WITH FORCEPS. WHAT WAS THE ACCESS SITE CHOSEN? COMMON FEMORAL. DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? RAABE 6 FR X 55 CM. WHAT APPROACH WAS USED TO ACCESS THE TARGET SITE? CONTRALATERAL, NO. WHAT WAS THE TARGET LOCATION FOR THE STENT? SFA, STENT DID NOT ENTER VASCULAR. WHAT ARTERY WAS THE STENT PLACED IN? PROXIMAL SFA TO PROXIMAL POPLITEAL. ANOTHER ZILVER PTX 6 MM X 100 MM WAS PLACED NOT THE KINKED SHAFT ONE. IT WAS ALSO FROM THE SAME LOT NUMBER. WHAT DISEASE PATHOLOGY WAS BEING TREATED? MIXED PLAQUE. DID THE STENT DELIVERY SYSTEM CROSS THE TARGET LOCATION? NO, USED ANOTHER ZILVER PTX STENT- 6 MM X 100 MM THAT CROSSED USING THE SAME .018¿ WIRE WHAT WAS THE ACCESS SITE CHOSEN? COMMON FEMORAL HAD NO BARING ON THE WIRE INITIALING NOT PASSING THROUGH THE WIRE LUMEN OF STENT. WAS THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774894 ↗
• MalfunctionJul 18, 2022Improper or Incorrect Procedure or Method; Positioning Problem; Improper or Incorrect Procedure or Method; Positioning Problem

  AFTER THE DEPLOYMENT OF THE STENT, THEY RETRACTED THE STENT DEPLOYMENT DELIVERY SYSTEM. THEY WERE THEN GOING TO PUT A BALLOON UP TO POST DILATE AND THEY NOTICED THAT THE STENT WAS TILTED. 6.3.1.1 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NO ¿ IF YES, PLEASE DESCRIBE. NO. 6.3.1.2 WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. 6.3.1.3 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. ¿ IF YES, PLEASE DESCRIBE. 6.3.1.4 DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. ¿ IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 6.3.1.5 HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6.3.1.6 HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. ¿ PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PREFIX ZIV6-PTX/ZISV6-PTX 3.60 ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO- YES I CAN PASS ALONG POST INITIAL DEPLOYMENT PICTURE AND PRE POST DILATION ANGIOPLASTY 3.61 WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041804 ↗
• MalfunctionJun 29, 2021Off-Label Use; Off-Label Use

  PER CUSTOMER - (B)(6) 202 - DR (B)(6) DID A LEG CASE TODAY TO FIX AN OSTIAL SFA AND A PROX ANT TIBIAL. AFTER PRE DILATING MULTIPLE TIMES W A 4X120 PTA BALLOON, A ZILVER PTX 6X140 WAS SUCCESSFULLY DEPLOYED, BUT THE 2ND STENT A 6X100 DID NOT CROSS AFTER 3 ATTEMPTS AND MORE PRE DILATIONS TO THAT AREA. THE AT WAS SUCCESSFULLY STENTED W SMALLER DES. ACCESS WAS FROM THE FOOT (AT) THRU A 6FR SHEATH AND A .035 GLIDEWIRE ADVANTAGE WAS THE INITIAL WIRE FOR THE .035 STENTS. USER ERROR - ATTEMPTING TO CROSS LESION 3 TIMES ALTHOUGH RESISTANCE WAS FELT. PATIENT/EVENT INFO NOTES: ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE,LENGTH)? DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? WHAT APPROACH WAS USED TO ACCESS THE TARGET SITE? CONTRALATERAL, IPSILATERAL, ANTEGRADE, RETROGRADE, OTHER ¿ PLEASE SPECIFY FOR OTHER: ¿ IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, YES, NO WHAT WAS THE TARGET LOCATION FOR THE STENT? WHAT ARTERY WAS THE STENT PLACED I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084283 ↗
• MalfunctionJul 8, 2020Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  DEVICE EVALUATED ON (B)(6) 2020: "STENT PARTIALLY DEPLOYED AND FRACTURED. RETRACTION WIRE SEPARATED FROM SRS." ADDING PRECEDENCE'S FOR 'STENT FRACTURE' AND 'RETRACTION WIRE SEPARATES FROM STENT RETRACTION SHEATH'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10248261 ↗
• MalfunctionSep 5, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "AFTER THE STENT FULLY DEPLOYED, PHYSICIAN COULD NOT REMOVE THE DELIVERY SYSTEM OVER THE WIRE. AT THAT POINT, PHYSICIAN DELIBERATELY LOST WIRE ACCESS SO HE COULD REMOVE WIRE AND DELIVERY SYSTEM. STENT REMAINS IN PATIENT AS INTENDED." FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DELIVERY SYSTEM CANNOT BE WITHDRAWN¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964483 ↗
• MalfunctionJul 22, 2019Fracture; Fracture

  "THE DELIVERY SYSTEM EVIDENTLY DID NOT TRACK WELL DOWN THE VESSEL (WHICH WAS PRE-DILATED) AND THE STENT WOULD NOT DEPLOY. AFTER THE PROBLEM, THEY BALLOONED THE VESSEL. AFTER BALLOONING, THEY DECIDED A STENT WAS NOT NECESSARY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811617 ↗
• MalfunctionJun 20, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "WHEN THEY WENT TO DEPLOY THE STENT THE THUMBWHEEL DEPLOYED ABOUT 1-2CM AND THEN THE THUMBWHEEL BEGAN TO TURN FREELY WITHOUT DEPLOYING. A PIECE OF WIRE IS ALSO STICKING OUT OF THE THUMBWHEEL; IT IS NOT KNOWN AT WHAT POINT THE WIRE CAME OUT, BUT THE WIRE SEEMED TO BE TURNING WITH THE WHEEL. DEVICE WAS REMOVED AND ANOTHER OF THE SAME GPN WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY." 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¿ AND "STENT RETRACTION WIRE SEPARATES". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8715405 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 AN ARTERIOGRAM OF THE LOWER LEG WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT WAS PERFORMED AND 5 COOK STENTS WERE PLACED. NO FLOW WAS NOTED, AND THE PHYSICIAN INDICATED THEY DID NOT BELIEVE IT WAS DUE TO THE DEVICES. ON (B)(6) 2019 THE DM FOLLOWED UP TO CHECK ON THE PATIENT, AND THE PHYSICIAN INFORMED THE DM THAT THE PATIENT HAD TO HAVE AMPUTATION (UNKNOWN LOCATION). PATIENT IS STABLE AND HEALING WELL.

  Patient problems: Disability; Hypovolemia

  MAUDE report 8339344 ↗
• MalfunctionJul 5, 2018Stretched; Delivery System Failure; Activation, Positioning or Separation Problem; Stretched; Delivery System Failure; Activation, Positioning or Separation Problem

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT", ¿DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT¿ AND "STENT ELONGATION". AS REPORTED TO CUSTOMER RELATIONS: "PROCEDURE WAS AN ARTERIOGRAM. VERY CALCIFIED SFA. THE 6X100 PTX CROSSED BUT THE THUMBWHEEL BROKE. PHYSICIAN PULLED THE SYSTEM BACK WHICH RELEASED THE STENT BUT STRETCHED TO DOUBLE THE LENGTH. THEY THEN PUT A COVER STENT IN. NO ADVERSE EVENT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663588 ↗
• MalfunctionJul 5, 2018Fracture; Delivery System Failure; Fracture; Delivery System Failure

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿STENT FRACTURE" AND "DEPLOYMENT ISSUE RESULTING IN EXPOSED STENT REMOVED FROM PATIENT WITH THE DELIVERY SYSTEM". AS REPORTED TO CUSTOMER RELATIONS, "THE STENT STOPPED DEPLOYING AND HALF OF THE STENT REMAINS INSIDE THE PATIENT. THE DEPLOYMENT SYSTEM WAS PULLED OUT".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663542 ↗
• MalfunctionJun 7, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT'. AS REPORTED TO CUSTOMER RELATIONS: "EITHER MID-DEPLOYMENT OR AFTER DEPLOYMENT, THE HANDLE BROKE APART. THEY DID NOT ULTIMATELY USE THE STENT, IT WAS REMOVED FROM PATIENT. EVERYTHING OF THE DEVICE MINUS THE STENT AVAILABLE FOR RETURN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577003 ↗
• MalfunctionSep 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: RELATED TO REPORT # 3001845648-2017-00302. THE IMAGE REVIEW FOR REPORT # 3001845648-2017-00302 OBSERVED STENT SHORTENING. AN ADDITIONAL COMPLAINT WAS OPENED TO RECORD THIS FAILURE MODE. (B)(4) COMPLAINT DETAILS: RIGHT LEG ANGIO GRAM FOR A CLAUDICATION. A G38482 FROM LOT NUMBER C1334468 WAS THE FIRST STENT DEPLOYED IN THE PATIENTS SFA. THEN THE FACILITY DEPLOYED A SECOND STENT, A G38481 FROM LOT NUMBER C1262496. WHILE ATTEMPTING TO WITHDRAWAL THE DEPLOYMENT SYSTEM; THE ZILVER PTX DEPLOYMENT SYSTEM GOT CAUGHT ON THE AMPLATZ. THSF-35-260-AES WIRE FROM LOT NUMBER 7455253 . TO MAINTAIN ACCESS, THE G11638 WAS PARKED AT THE UPPER END OF THE PROXIMAL STENT. THE PHYSICIAN HAD PULL THE DEPLOYMENT SYSTEM AND THE WIRE OUT TOGETHER AT THE SAME TIME. THEY INSERTED A NEW AMPLATZ WIRE. THEY POST DILATED THE STENT WITH A MUSTANG BALLOON AND THE RUN LOOKED GOOD. HOWEVER, A CLOT WAS REVEALED IN THE PROXIMAL STENT. THEY DE-THROMBOSED WITH TPA USING THE ANGIODYNAMICS UNIFUSE CATHETER SYSTEM. THEN, THE DOCTOR USED AN ANGIO JET MACHINE IN THE P

  Patient problems: Thrombus

  MAUDE report 6900261 ↗
• MalfunctionSep 19, 2017Device Expiration Issue; Device Expiration Issue

  THE SALES REP RECEIVED STENTS FROM TFORCE CRITICAL AND TOOK THEM TO THE FACILITY. WHEN HE WENT TO BILL THE FACILITY FOR THE DEVICE THEY USED, HE NOTICED THAT IT WAS EXPIRED. THE PROCEDURE WAS A SUCCESS AND NO ADVERSE EVENTS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6875010 ↗
• MalfunctionJul 25, 2017Delivery System Failure; Delivery System Failure

  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: RIGHT LEG ANGIOGRAM FOR A CLAUDICATION. A G38482 FROM LOT NUMBER C1334468 WAS THE FIRST STENT DEPLOYED IN THE PATIENTS SFA. THEN THE FACILITY DEPLOYED A SECOND STENT, A G38481 FROM LOT NUMBER C1262496. WHILE ATTEMPTING TO WITHDRAWAL THE DEPLOYMENT SYSTEM; THE ZILVER PTX DEPLOYMENT SYSTEM GOT CAUGHT ON THE AMPLATZ. THSF-35-260-AES WIRE FROM LOT NUMBER 7455253 . TO MAINTAIN ACCESS, THE G11638 WAS PARKED AT THE UPPER END OF THE PROXIMAL STENT. THE PHYSICIAN HAD PULL THE DEPLOYMENT SYSTEM AND THE WIRE OUT TOGETHER AT THE SAME TIME. THEY INSERTED A NEW AMPLATZ WIRE. THEY POST DILATED THE STENT WITH A MUSTANG BALLOON AND THE RUN LOOKED GOOD. HOWEVER, A CLOT WAS REVEALED IN THE PROXIMAL STENT. THEY DE-THROMBOSED WITH TPA USING THE ANGIODYNAMICS UNIFUSE CATHETER SYSTEM. THEN, THE DOCTOR USED AN ANGIO JET MACHINE IN THE PROXIMAL STENT. THEN THE DOCTOR DID ANOTHER RUN AND IT SHOWED THE PROXIMAL STENT WAS NOT CLEAR, BUT THE CLOT HAD MOVED DOWN THRU BOTH STENTS BEYOND THE END OF THE DISTAL STENT AND DOWN TO THE OF THE TRIFURCATION

  Patient problems: Thrombus

  MAUDE report 6739984 ↗
• InjuryAug 18, 2016Occlusion Within Device; Occlusion Within Device

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: PHYSICIAN PLACED 3 ZILVER PTX STENTS AND THEY OCCLUDED/THROMBOSED BEFORE PROCEDURE WAS COMPLETE. REFERENCE ALSO REPORTS # 3001845648-2016-00218 AND 3001845648-2016-00219.

  Patient problems: Reocclusion

  MAUDE report 5885612 ↗
• InjuryAug 8, 2016No Apparent Adverse Event; No Apparent Adverse Event

  THREE ZILVER GRAFTS WERE IMPLANTED IN THE PATIENTS LEFT LEG ON (B)(6) 2016. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT HAD GREAT BLOOD. ON (B)(6) 2016 THE PATIENT CALLED BACK INTO THE OFFICE AND SPOKE WITH THE PHYSICIAN INDICATING SHE HAD A RAISED RASH FROM HER KNEE DOWN TO HER FOOT. THE PHYSICIAN TOLD THE PATIENT TO COME BACK INTO THE OFFICE STRAIGHT AWAY FOR EXAMINATION. UPON EXAMINATION BY THE PHYSICIAN, THERE WERE NO OTHER NOTED ALLERGIC REACTIONS OR COMPLICATIONS. THE PHYSICIAN PERFORMED A BLOOD TEST ON THE PATIENT AND CONFIRMED THERE WAS NO INFECTION. AT THIS POINT, THE PHYSICIAN BELIEVED THE RASH WAS STRICTLY SECLUDED TO THE LEFT LEG DUE TO THE IMPLANTED STENTS. THE PHYSICIAN PRESCRIBED A STEROID DOSE PACK FOR THE PATIENT. UPON FOLLOW UP ON (B)(6) 2016, THE RASH HAS REDUCED APPROXIMATELY 25%; HOWEVER 75% PERCENT OF THE RASH REMAINS. THE PATIENTS FAMILY IS EXTREMELY CONCERNED BECAUSE THE PATIENT WAS PLACED ON A BLOOD THINNER (PLAVIX), WHICH KEEPS THE STENTS OPEN. THE FACILITY BELIEVES THE REACTION IS NOT DUE TO THE PLAVIX, HOWEVER SOLELY RELATED TO THE IMPLANTED STENTS. AS THREE ZILVER STENTS ARE SUSPECTED TO BE INVOLVED IN THIS EVENT, A SEPARATE REPORT HAS BEEN

  Patient problems: Rash

  MAUDE report 5853354 ↗