Zilver 635 G43868Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002438689), received between Dec 2, 2020 and Apr 10, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (2 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 18, 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.

• MalfunctionApr 10, 2025Premature Activation; Deformation Due to Compressive Stress; Premature Activation; Deformation Due to Compressive Stress

  WHEN THE PHYSICIAN STARTED TO INSERT THE DELIVERY SYSTEM ALONG THE GW OUTSIDE THE PATIENT'S BODY, THE STENT BECAME EXPOSED (EXPANDED) EVEN THOUGH THE SAFETY LOCK WAS ENGAGED. HE COMPLETED THE PROCEDURE WITH ANOTHER MANUFACTURER'S DEICE (DETAIL UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21812537 ↗
• MalfunctionApr 3, 2025Off-Label Use; Failure to Deflate; Off-Label Use; Failure to Deflate

  SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED TO UPDATE ANNEX CODING FOR OFF-LABEL USE BASED ON THE CONFIRMATION RECEIVED FROM CLINICAL ON (B)(6) 2025. CLINICAL INPUT STATED: "THE USE OF THE ZIV STENT IN THE COMMON BILE DUCT IS ABNORMAL USE/OFF-LABEL USE. THIS ABNORMAL USE HAVE LIKELY LED TO THE STENT FRACTURE AS PER THE IMAGING REVIEW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762246 ↗
• InjuryApr 1, 2025Failure to Deflate; Failure to Deflate

  AS REPORTED PER THE DISTRICT MANAGER: I RECEIVED A CALL TODAY FROM THIS ACCOUNT ABOUT A STENT THAT FRACTURED. I AM STILL GATHERING THE INFORMATION ABOUT THE OCCURRENCE. THE FOLLOWING INFORMATION WAS RECEIVED VIA EMAIL ON 25MAR2025. "THE PATIENT WAS 68 Y/O FEMALE WITH PANCREATIC ADENOCARCINOMA. SHE WAS 5¿2¿ AND 110 LBS. PATIENT HAD PLACEMENT OF INTERNAL/EXTERNAL BILIARY DRAINAGE. ON (B)(6)2025 THE STENT WAS INTERNALIZED WITH A ZILVER STENT GPN-G43868, LOT # C2138632. AN INTERNAL/EXTERNAL BILIARY DRAIN WAS LEFT THROUGH THE ZILVER STENT. PATIENT WAS BROUGHT BACK ON (B)(6)2025 FOR INJECTION AND REMOVAL OF BILIARY DRAIN. THE STENT APPEARED TO BE INTACT THEN. PATIENT RETURNED TO ENDOSCOPY (B)(6)2025 FOR REPEAT SCOPE. IT WAS NOTED THEN THAT THE STENT WAS FRACTURED. PATIENT RETURNED TO IR FOR PERCUTANEOUS BILIARY DRAINAGE ON (B)(6)2025. DOCTOR WAS UNABLE TO GAIN ACCESS INN THE BILIARY TREE AS THE PATIENTS¿ DUCTS WERE NOT DILATED. INTERNAL STENT WAS DRAINING AND NOT OCCLUDED. THERE WAS NO ADVERSE EFFECTS AT THIS TIME AS THE STENT WAS STILL DRAINING DUCTS." A FORMAL COMPLAINT WAS NOT FILED OR REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741297 ↗
• MalfunctionDec 22, 2020Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 01-APR-2021.

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

  MAUDE report 11055662 ↗
• MalfunctionDec 2, 2020Fracture; Fracture

  THIS IS A COMPLETE REPORT. THE INVESTIGATION WAS COMPLETED ON 26-MAR-21 AND THE RESULTS AND CONCLUSIONS ARE OUTLINED IN SECTION H OF THIS REPORT. UPON POST PLACEMENT DILATION, RESISTANCE WAS MET WHEN REMOVING THE BALLOON. THE BALLOON WAS REMOVED AND A FRACTURED PORTION OF THE STENT CAME OUT WITH THE BALLOON. THE STENT WAS LEFT IN PLACE AND THE PROCEDURE WAS CONSIDERED COMPLETE AND SUCCESSFUL PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NA.

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

  MAUDE report 10936226 ↗