Zilver PTX G38491Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002384917), received between Feb 14, 2019 and Jan 23, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Fracture; Improper or Incorrect Procedure or Method

  A SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE ON (B)(6) 2026 TO CAPTURE THE INVESTIGATION CONCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159857 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 03-JUL-2025. ADDITIONAL INFORMATION RECEIVED ON 03APR2025. IS AN ACKNOWLEDGMENT LETTER (FORMAL NOTIFICATION OF THE COMPLAINT BEING RECEIVED) REQUIRED? NO. IS ANY ACCOUNT ACTION NEEDED (CREDIT, NO CHARGE REPLACEMENT, NO ACTION, INVESTIGATION RESULTS, ETC.)? NO. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO. LOT: G38483 LOT C2214890, G38491 LOT C2194082, G38491 LOT C2194082 & G38487 LOT C2248788 IS THE DEVICE AVAILABLE FOR RETURN? NO, THEY WERE DEPLOYED IN THE PATIENT CAN YOU PROVIDE ANY PATIENT INFORMATION (AGE, WEIGHT, GENDER, PRE-EXISTING CONDITIONS)? HYPOTENSION, OVERWEIGHT (UNSURE OF LBS) & FEMALE. THESE 3 RELATED COMPLAINTS HAVE THE SAME COMMENT EXPRESSED BY THE USER AT THE END OF THE DESCRIPTION OF EVENT (SEE BELOW). HAS THIS ISSUE ACTUALLY OCCURRED BEFORE FOR HER WHERE SHE EXPERIENCED THE STENTS JUMPING DUE TO THE THUMBWHEEL DEPLOYMENT MECHANISM OR, IS SHE MERELY EXPRESSING AN OPINION ON WHAT SHE FEELS COULD HAPPEN IN THE FUTURE? SHE IS MERELY EXPRESSING OPINION ON WHAT SHE FEELS COULD HAPPEN IN THE FUTURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21702179 ↗
• MalfunctionFeb 13, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED TO CUSTOMER RELATIONS: THE SHAFT OF THE STENT DELIVERY SYSTEM BROKE WHILE ADVANCING IN THROUGH PEDAL ACCESS. I DO NOT HAVE THE PRODUCT AVAILABLE TO SEND BACK. THE PRODUCT MADE PATIENT CONTACT, BUT NO PATIENT WAS HARMED, AND THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT WAS HARMED, AND THE CASE WAS SUCCESSFULLY COMPLETED. PER THE CLINICAL SPECIALIST: MY ANSWERS ARE BELOW IN RED. I ANSWERED THESE THE BEST I COULD AFTER SPEAKING WITH STAFF. SOUNDS LIKE IT WAS DIFFICULT TO CROSS AND QUITE A BIT OF FORCE MIGHT¿VE BEEN USED TO TRY AND PUT THE DELIVERY UP. 1. CONTACT AT FACILITY AND CONTACT INFO: NA 2. WHAT WAS THE DATE OF THE OCCURRENCE? (B)(6) 2025. 3. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO. 4. IS AN ACKNOWLEDGMENT LETTER (FORMAL NOTIFICATION OF THE COMPLAINT BEING RECEIVED) REQUIRED? NO. 5. IS ANY ACCOUNT ACTION NEEDED (CREDIT, NO CHARGE REPLACEMENT, NO ACTION, INVESTIGATION RESULTS, ETC.¿)? NO. 6. LOT: C2216599. 7. GPN: G38491. 8. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? ANGIOGRAM. 9. CAN YOU PROVIDE ANY PATIENT INFORMATION (AGE, WEIGHT, GENDER, PREEXISTING CONDITIONS)? 10. ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376078 ↗
• MalfunctionApr 6, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  WHEN ATTEMPTING TO DEPLOY THE STENT THE PHYSICIAN STARTED TO THE THUMB WHEEL ROTATION WITH INITIAL RETRACTION OF THE RETRACTION SHEATH. BEFORE THE STENT WAS EXPOSED THE RETRACTION SHEATH STOPPED MOVING EVEN THOUGH THE PHYSICIAN WAS CONTINUING TO ROTATE THE THUMB WHEEL. THE PHYSICIAN DECIDED TO REMOVE THE DEPLOYMENT SYSTEM BUT THE SYSTEM WOULD NOT GO BACK INTO THE 6FR SHEATH. THE PHYSICIAN REMOVED THE WHOLE SYSTEM AND SHEATH WIRE. ONCE THE SYSTEM WAS REMOVED IT WAS NOTICED THAT THE WHITE NOSE CONE CAME DETACHED FROM THE DELIVERY SYSTEM AND LEFT IN THE POPLITEAL ARTERY. THE NOSE CONE WAS SNARED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH TWO OTHER G38491/LOT #C2001290. 7FR X 55CM RAABE ACCESS SHEATH USED ON REPLACEMENT DEVICE. COMPLAINT OPENED TO CAPTURE THE USE OF A WRONG SIZE ACCESS SHEATH. RELATED FILE: PR385391. PATIENT OUTCOME: NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688798 ↗
• InjuryFeb 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED BASED ON THE IMAGE REVIEW ON 15-FEB-2023 AND THE COMPLETION OF THE LAB EVALUATION ON 28-FEB-2023 AND 08-MAR-2023 IMPRESSION: 1. THE COMPLAINT OF DELIVERY SYSTEM TIP FRACTURE AND DISTAL EMBOLIZATION IS CONFIRMED. RETRACTION SHEATH PIN WHEEL SEPARATION THAT PREVENTED STENT IMPLANTATION CANNOT BE CONFIRMED AS IMAGING OF THE EVENT WAS NOT PROVIDED. 2. THE PROVIDED IMAGE DEMONSTRATES A KINKED WIRE SIGNIFICANTLY SMALLER THAN AN .035 WIRE ADJACENT THE DELIVERY SYSTEM FRAGMENT. THIS MOST LIKELY WAS THE VIPER WIRE AND IS INCONSISTENT WITH THE COMPLAINT REPORT¿S WIRE SEQUENCE. ACCORDING TO THE REPORT THE WIRE SHOULD HAVE BEEN THE .035 SUPRACORE WIRE. 3. IF THE GUIDEWIRE KINK HAD BEEN INSIDE THE DELIVERY SYSTEM, IT WOULD PROVIDE A PLAUSIBLE MECHANISM FOR RETRACTION SHEATH/PIN WHEEL SEPARATION AND DELIVERY SYSTEM TIP SEPARATION WITH DISTAL EMBOLIZATION. IF THE KINK WAS INSIDE THE DISTAL DELIVERY SYSTEM DURING ATTEMPTED DEPLOYMENT, THE KINK COULD HAVE DISTORTED THE DISTAL INNER CATHETER ENOUGH TO BIND THE RETRACTION SHEATH. PINWHEEL ROTATION COULD HAVE SEPARATED THE PINWHEEL MECHANISM. THE KINK COULD HAVE ALSO COULD HAVE PREVENTED THE DELIVERY SYSTEM¿S REM

  Patient problems: Foreign Body In Patient

  MAUDE report 16349374 ↗
• InjuryFeb 3, 2023

  REPORTED BY THE DM ON BEHALF OF THE CUSTOMER VIA EMAIL - WHEN ATTEMPTING TO DEPLOY THE STENT THE PHYSICIAN STARTED TO THE THUMB WHEEL ROTATION WITH INITIAL RETRACTION OF THE RETRACTION SHEATH. BEFORE THE STENT WAS EXPOSED THE RETRACTION SHEATH STOPPED MOVING EVEN THOUGH THE PHYSICIAN WAS CONTINUING TO ROTATE THE THUMB WHEEL. THE PHYSICIAN DECIDED TO REMOVE THE DEPLOYMENT SYSTEM BUT THE SYSTEM WOULD NOT GO BACK INTO THE 6FR SHEATH. THE PHYSICIAN REMOVED THE WHOLE SYSTEM AND SHEATH WIRE. ONCE THE SYSTEM WAS REMOVED IT WAS NOTICED THAT THE WHITE NOSE CONE CAME DETACHED FROM THE DELIVERY SYSTEM AND LEFT IN THE POPLITEAL ARTERY. THE NOSE CONE WAS SNARED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH TWO OTHER G38491/LOT #C2001290. PATIENT OUTCOME: THE FOLLOWING HAS BEEN ANSWERED- JM 16JAN2023. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? IF YES, PLEASE DESCRIBE. YES! THE WHITE NOSE CONE OF THE DELIVERY SYSTEM BROKE OFF AND TRAVELED DOWN INTO THE RT TP TRUNK. 2. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES! 3. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? IF YES, PLEASE SPECIFY

  MAUDE report 16292873 ↗
• MalfunctionAug 20, 2021Difficult to Remove; Difficult or Delayed Activation; Difficult to Remove; Difficult or Delayed Activation

  "THE DEPLOYMENT SYSTEM, AFTER THE STENT WAS DEPLOYED, WOULD NOT COME OFF THE WIRE. THE USER ADVANCED THE DEPLOYMENT SYSTEM BEYOND THE STENT, WERE ABLE TO THEN REMOVE THE WIRE, BUT WERE NOT ABLE TO REINSERT A WIRE INTO THE LUMEN OF THE DEVICE (WOULDN'T EVEN GET PAST THE HANDLE). AT THAT POINT, DM RECOMMENDED CUTTING THE HANDLE AWAY WITH SHEARS AND TRYING TO REINSERT THE WIRE INTO THE LUMEN OF THE DEPLOYMENT DEVICE. USER WAS UNABLE TO ADVANCE THE WIRE AFTER SHEARING, USER REMOVED REMAINDER OF DEPLOYMENT SYSTEM FROM PATIENT, AND CONTINUED BY RECROSSING THE STENTS TO COMPLETE THE PROCEDURE. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12347344 ↗
• MalfunctionDec 23, 2019Material Deformation; Activation Failure; Material Deformation; Activation Failure

  PER COMPLAINT EMAIL: ANTEGRADE STICK TO THE LEFT LEG USING A 6FR 10CM SHEATH (COMPANY NOT SPECIFIED). FROM DISTAL TO PROXIMAL THE FOLLOWING STENTS WERE PLACED IN THE SFA: 6X100, 6X140, 7X140, 7X120, 7X60. THE THREE STENTS IN THE MIDDLE (6X140, 7X140, 7X120) ALL DID NOT DEPLOY CORRECTLY. IN THE IMAGE, THE STENTS LOOKED LIKE THEY WERE CRUNCHED UP AND NOT FULLY DEPLOYED. HOWEVER BOTH OF THE STENTS DISTAL AND PROXIMAL DEPLOYED JUST FINE. THERE WERE ALL DEPLOYED IN THE LEFT SFA. THE PATIENT DID NOT HAVE ANY FURTHER COMPLICATIONS OR ANY LONGER OF HOSPITAL STAY, THE OUTCOME LOOKED FINE EXCEPT HE HAD TO USE 5 STENTS INSTEAD OF 3. G38490 ¿ 7X120 LOT: C1547234 [PR286445]. G38483 ¿ 6X140 LOT: C1657393 [PR286450]. G38491 ¿ 7X140 LOT: C1577799 [PR286451].

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9509495 ↗
• InjurySep 5, 2019Stretched; Improper or Incorrect Procedure or Method; Stretched; Improper or Incorrect Procedure or Method

  AS REPORTED TO CUSTOMER RELATIONS, "WHEN ATTEMPTING TO DEPLOY THE STENT, ANTEGRADE AND IPSILATERAL. THE STENT ELONGATED ABOUT 90MM'S. DUE TO THE DELIVERY SYSTEM GETTING CAUGHT IN THE VALVE ON THE SHORT SHEATH. THEY BROUGHT THE PATIENT 2 HOURS LATER AS THE FACILITY DECIDED THEY NEEDED TO PUT ANOTHER STENT IN TO COVER THE ELONGATED ZILVER PTX." FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS SECONDARY INTERVENTION WAS REQUIRED. ALSO REPORTABLE BASED ON "STENT ELONGATION" PRECEDENCE.

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

  MAUDE report 8964943 ↗
• InjurySep 3, 2019Stretched; Stretched

  AS REPORTED BY THE INITIAL REPORTER, "WHEN ATTEMPTING TO DEPLOY THE STENT, ANTEGRADE AND IPSILATERAL. THE STENT ELONGATED ABOUT 90MM'S. DUE TO THE DELIVERY SYSTEM GETTING CAUGHT IN THE VALVE ON THE SHORT SHEATH. THEY BROUGHT THE PATIENT 2 HOURS LATER AS THE FACILITY DECIDED THEY NEEDED TO PUT ANOTHER STENT IN TO COVER THE ELONGATED ZILVER PTX."

  Patient problems: No Code Available

  MAUDE report 8957933 ↗
• 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 8339276 ↗