Zilver PTX G38480Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002384801), received between Jun 21, 2016 and Jan 23, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-MAR-26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159708 ↗
• InjurySep 15, 2023Collapse; Adverse Event Without Identified Device or Use Problem; Collapse; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER, "PROCEDURE WAS YESTERDAY 17AUG2023, PHYSICIAN CALLED THIS AFTERNOON STATING THE STENT HAD SHUT DOWN AND THAT THERE WAS GOING TO BE ANOTHER SURGERY TODAY TO SEE WHAT WAS GOING ON. THE STENT DEPLOYED SUCCESSFULLY DURING THE 1ST PROCEDURE; POST STENT ANGIOGRAM LOOKED SUCCESSFUL. WILL FIND OUT TODAY IF THE STENT FAILED OR SOMETHING ELSE MIGHT HAVE CAUSED THE OCCURRENCE." THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON 18AUG2023. SG: 18AUG2023. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? YES POSSIBLY, WAITING FOR CONFIRMATION, HAVING A PROCEDURE @ 4PM (B)(6) 2023. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES POSSIBLY, WAITING FOR CONFIRMATION, HAVING A PROCEDURE @ 4PM (B)(6) 2023. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES POSSIBLY, WAITING FOR CONFIRMATION, HAVING A PROCEDURE @ 4PM (B)(6) 2023. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 17754557 ↗
• InjurySep 13, 2023Collapse; Collapse

  ACCORDING TO THE INITIAL REPORTER, "PROCEDURE WAS YESTERDAY (B)(6) 2023, PHYSICIAN CALLED THIS AFTERNOON STATING THE STENT HAD SHUT DOWN AND THAT THERE WAS GOING TO BE ANOTHER SURGERY TODAY TO SEE WHAT WAS GOING ON. THE STENT DEPLOYED SUCCESSFULLY DURING THE 1ST PROCEDURE; POST STENT ANGIOGRAM LOOKED SUCCESSFUL. WILL FIND OUT TODAY IF THE STENT FAILED OR SOMETHING ELSE MIGHT HAVE CAUSED THE OCCURRENCE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 17737854 ↗
• MalfunctionApr 13, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731762 ↗
• MalfunctionApr 13, 2023Improper or Incorrect Procedure or Method; Structural Problem; Improper or Incorrect Procedure or Method; Structural Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A STENTING OF THE SFA PROCEDURE IN WHICH THE ZILVER PTX 35 DRUG-ELUTING STENT, G38480, WAS TO BE USED. WHILE THE DEVICE WAS ON THE BACK TABLE THE PHYSICIAN FLUSHED THE DEVICE AS PER THE IFU (DISTRICT MANAGER CONFIRMED IT WAS DONE CORRECTLY AS THEY WERE PRESENT DURING THE CASE). THEN WHEN PHYSICIAN TRIED TO PLACE THE WIRE DOWN THE CATHETER THE WIRE WOULD NOT GO THROUGH. THE PHYSICIAN NOTED A KINK ABOUT HALF WAY UP THE CATHETER. THE PHYSICIAN NOTED THERE WAS NO DAMAGE TO THE MARKETING BOX NOR THE DEVICE PACKAGING. ANOTHER ZILVER WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. 3.60 ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? NO 3.61 WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? YES 3.62 WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? NO, JUST THE WIRE THAT WOULD NOT GO THROUGH. 3.63 DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE,LENGTH)? 7FR X 45CM ANSEL 3.64 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? DID NOT GET THIS FAR. THE REMAINING QUESTIONS NOT APPLICABLE AS THIS OCCURRED PRIOR TO PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731738 ↗
• MalfunctionJun 4, 2021Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  FINAL MDR CANCELLATION REPORT BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6)2021 AND REASSESSMENT OF FILE TO BE NO LONGER REPORTABLE AS THIS 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)¿.

  Patient problems: Insufficient Information

  MAUDE report 11937736 ↗
• MalfunctionFeb 10, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 12-APR-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11307833 ↗
• MalfunctionApr 17, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  PER REP - YESTERDAY WHILE IN A CASE I HAD A DR PLACE A 6X80 ZILVER PTX STENT, I WATCHED THE TECH FLUSH THE STENT PROPERLY AND THEY DEPLOYED IT CORRECTLY. THE STENT SEEM TO BE MOVING AS THEY WERE DEPLOYING AND ONCE THE STENT WAS FULLY DEPLOYED WE PLACED A 6X80 MEDTRONIC EVERCROSS BALLOON, THE STENT SEEM TO BE SIGNIFICANTLY SHORTER THAN THE BALLOON. THE DOCTOR ALSO HAD GLOW TAPE WITH MEASUREMENTS ON THE PATIENTS LEG, SO YOU CAN SEE THE SIZING. I TRIPLE CHECKED THE STENT BOX AND INSIDE PACKAGING THAT IS WAS A 6X80 STENT AND THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522938 ↗
• InjuryMar 14, 2019Material Deformation; Material Deformation

  PER EMAIL: "DR. (B)(6) FROM (B)(6) HOSPITAL ((B)(4)) TOLD ME THAT THE STENT JUMPED UPON DEPLOYMENT AND BECAME ¿CRIMPED¿ IN THE SFA. THIS DELAYED THE PROCEDURE AND IT BECAME NECESSARY TO IMPLANT ANOTHER STENT INSIDE THE ZPTX TO REOPEN IT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8420991 ↗
• InjurySep 12, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS COMPLAINT IS IN RELATION TO THE FOURTH STENT (G38480, LOT# C1480754) THAT COMPRESSED. REFERENCE REPORT # 3001845648-2018-00423 FOR THE REMAINING 3 STENTS. AS REPORTED TO CUSTOMER RELATIONS: "UPON DELIVERY OF THE STENT, THE DISTAL TIP FRACTURED AND CAME COMPLETELY APART. NOTHING LEFT IN PATIENT. PROCEDURE INVOLVED PLACING TWO 6X140S AND ONE 6X80--ANOTHER DEVICE WAS OPENED FOR THE COMPLAINT DEVICE, AND THESE THREE WORKED SUCCESSFULLY. ADDITIONAL INFORMATION PROVIDED TO DM BY CUSTOMER ON 14AUG2018: "THE COMPLAINT FROM DR. (B)(6)¿S CASE IS CONSIDERED A REPORTABLE EVENT AND THE INVESTIGATION TEAM HAS SOME ADDITIONAL QUESTIONS. IT HAS BEEN A LITTLE WHILE AGO, SO I WANTED TO REACH OUT TO CONFIRM THE DETAILS PRIOR TO RESPONDING TO THEIR REQUEST. COULD YOU CONFIRM IF THE PTX (G38483, LOT # C1463524) WAS IMPLANTED IN DR. (B)(6)¿S PATIENT ON (B)(6)? WERE ANY OF THE DEVICES STUCK ON THE WIRE GUIDE DURING THE PROCEDURE? IF SO, DID IT RESULT IN ANY OF THE PRODUCTS NOT BEING ABLE TO BE DEPLOYED. ADDITIONALLY, COULD YOU PROVIDE PRODUCT G# AND LOT# FOR THE OTHER PRODUCTS THAT WERE IMPLANTED ON (B)(6)? YES, PTX G38483, LOT# C1463524 WAS IMPLANTED. IN FACT, 3 OF THE SAME SIZE AND LOT# WERE IMPLA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7868960 ↗
• MalfunctionMay 23, 2018Difficult to Remove; Difficult to Remove

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿'DELIVERY SYSTEM CANNOT BE WITHDRAWN". AS REPORTED TO CUSTOMER RELATIONS, "AFTER THEY WENT UP AND OVER THE BIFURCATION, THEY COULD NOT ADVANCE THE STENT. THEY TRIED TO DILATE BY PUTTING A BALLOON OVER THE WIRE; HOWEVER, IT WOULD NOT ADVANCE AND THE STENT GOT STUCK ON THE WIRE. IT WAS NOT OPENED IN THE BODY AND THE STENT WAS OUTSIDE OF THE SHEATH. THE STENT AND WIRE WERE THEN REMOVED FROM THE PATIENT SAFELY. THEY CONTINUED THE PROCEDURE AND USED 3 OTHER PTX STENTS IN THE PATIENT AND USED AN AMPLATZ ULTRASTIFF WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY." 6 FR UP AND OVER SHEATH (UNKNOWN MAKE)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7536718 ↗
• MalfunctionAug 23, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY. AFTER CROSSING THE SFA CTO, PHYSICIAN EXCHANGED FOR A COOK AMPLATZ WIRE AND PRE-DILATED THE LESION WITH A 5MM BALLOON THEN DEPLOYED 2 ZILVER PTX STENTS WITHOUT ANY ISSUES, A 3RD ZILVER PTX 6MMX80MM STENT WAS NEEDED DISTAL TO THE ALREADY DEPLOYED ZILVER PTX STENTS. AFTER ADVANCING THE 6MMX80MM ZILVER PTX AND RIGHT BEFORE GETTING TO THE LESION TO BE STENTED, THE PHYSICIAN FELT A LOT OF RESISTANCE AND COULD NOT ADVANCE THE DELIVERY SYSTEM ANY FURTHER, HE REMOVED BOTH ZILVER PTX AND WIRE. ONCE REMOVED IT WAS NOTICED THAT THE WIRE WAS STUCK TO THE DELIVERY SYSTEM AT THE DISTAL END. PHYSICIAN PROCEEDED WITH A NEW WIRE (COOK ROSEN) AND A NEW 6X80 ZILVER PTX STENT AND COMPLETED THE PROCEDURE WITHOUT ANY ISSUES AND NO HARM/NO SIDE EFFECTS WAS CAUSED TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813266 ↗
• MalfunctionAug 23, 2017Difficult to Remove; Difficult to Remove

  THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY. INITIAL ANGIOGRAM REVEALED PATIENT HAD A PROXIMAL SFA OCCLUSION WHICH WAS BALLOONED AND THEN STENTED WITH A COOK PTX 6X100, G38481, OVER AN AMPLATZ ES WIRE AND THROUGH A 6F RAABE SHEATH THAT HAD BEEN PLACED UP AND OVER. STENT WAS POST-DILATED WITH .035 BALLOON. RUN OFF REVEALED AN ADDITIONAL LESION IN THE DISTAL SFA. PHYSICIAN INSERTED A 6X80 PTX OVER THE AMPLATZ WIRE BEYOND THE INITIAL STENT, INTENDING TO PRIMARY STENT. NEW STENT GOT STUCK ON THE WIRE. ENTIRE SYSTEM HAD TO BE REMOVED FROM THE SHEATH AND PATIENT IMMEDIATELY COMPLAINED OF 9/10 ABDOMINAL AND BACK PAIN. PHYSICIAN THEN INSERTED A FRESH AES WIRE AND DEPLOYED ANOTHER COOK 6X100 PTX G38481 IN DISTAL SFA WITHOUT INCIDENT, STENT WAS BALLOONED, PATIENT'S PAIN SUBSIDED, AND FINAL POST ANGIO WAS FINE. PATIENT NOW HAS GOOD RUNOFF. PHYSICIAN FEELS PATIENT'S COMPLAINT OF PAIN HAD NOTHING TO DO WITH THE COOK DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813165 ↗
• MalfunctionJun 21, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "THE STENT WAS NOT A 6X80 DEPLOYED BUT RATHER A 6X60. THE PHYSICIAN DEPLOYED A 2ND STENT TO MAKE IT LONG ENOUGH. NO HARM TO THE PATIENT AND IS DOING WELL. FDA MDR REPORT REQUIRED BASED ON THE REPORTING MALFUNCTION PRECEDENCE ESTABLISHED FOR THIS DEVICE FAMILY FOR THE ISSUE 'STENT SHORTENING ON DEPLOYMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5737754 ↗