Zilver 635 G23814Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002238142), received between Feb 26, 2020 and Apr 10, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Premature Activation

  THE STENT SLIPPED OUT OF ITS SHEATH JUST AS THE SURGEON WAS ATTEMPTING TO POSITION IT IN THE BILE DUCT WITHOUT HAVING REMOVED THE SMALL RED STOPPER. FROM THE STENT CLINICAL CONSEQUENCES OBSERVED: EXTREME DIFFICULTY IN REMOVING THE STENT FROM THE ENDOSCOPE. REPLACEMENT WITH A NEW STENT. INCREASED RISKS AND COMPLICATIONS ASSOCIATED WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838731 ↗
• MalfunctionMar 1, 2023Off-Label Use; Off-Label Use

  AFTER GASTRECTOMY, THE USER INSERTED ZILBS-635-8-12 FROM A ACCESSORY CHANNEL OF FUJIFILM/SHORT DOUBLE BALLOON ENDOSCOPE EI-580BT, AND PERFORMED ERCP FOR THE POSTOPERATIVE RECONSTRUCTION OF INTESTINAL TRACT. THERE WAS ALSO A TORTUOSITY OF ENDOSCOPE, HE FELT A RESISTANCE BUT COULD ADVANCE ZILBS-635-8-12 TO A TARGET SITE OF INTRAHEPATIC BILE DUCT. HE PULLED THE SHEATH TO DEPLOY THE STENT BUT THE SHEATH SEVERED. HE SELECTED ZILBS-635-8-10 INSTEAD TO COMPLETE PLACEMENT PROCEDURE. NO HEALTH HAZARD. GENERAL QUESTIONS FOR ALL COMPLAINTS: (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)WAS THE PACKAGE DAMAGED? NO. (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)HOW WAS THE DEVICE STORED? N/A. WAS A SPHINCTEROTOMY OR BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? UNKNOWN. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? NO. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? FUJIFILM/EI-580BT. WHAT WAS THE TARGET LOCATION FOR THE COMPLAINT DEVICE? LEFT INTRAHEPATIC BILE DUCT. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC?) PIOLAX/WRANGLER GUIDE WIRE MESA-3545M 0.035INCH H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458599 ↗
• InjuryAug 25, 2022Off-Label Use; Difficult to Remove; Activation, Positioning or Separation Problem; Off-Label Use; Difficult to Remove; Activation, Positioning or Separation Problem

  ZILVER BILIARY STENT WAS BEING DEPLOYED INSIDE A BOSTON SCIENTIFIC WALLFLEX STENT AND THE ZILVER STENT CONCERTINAED- SCRUNCHED UP AND THE GUIDEWIRE WAS INITIALLY STUCK. THE STENT REMAINED INSIDE THE PATIENT AND THEY PLACED A BOSTON SCIENTIFIC STENT INSIDE OF THE ZILVER. UPDATED AS PER COMPLAINT FORM RECEIVED FROM THE REP ON 29/7/2022 (B)(6): NOTES FRO NUM: WIRE BROKE OFF AFTER/DURING DEPLOYMENT, STENT DID NOT DEPLOY PROPERLY, SHORTENED IN LENGTH TO APPROX. 4 CM, BITS TORE. THE ZILVER REMAINED IN THE CBD AND PART OF THE OLYMPUS WIRE ALSO REMAINED. UPDATED COMPLAINT FORM RECEIVED FROM THE REP ON 4/8/2022 (B)(6): THE ZILVER STENT WAS TO BE PLACED IN THE HILAR REGION AND PLACED THROUGH AND ABOVE THE EXISTING UNCOVERED WALLFLEX STENT. THE ZILVER DEPLOYED WITHOUT ANY ISSUES AND DR WAS HAPPY WITH THE POSITION. ONCE REMOVING THE STENT CATHETER AND WIRE GUIDE THE WIRE GUIDE DRAGGED THE STENT DOWN AND THE RADIOPAQUE PART OF THE WIRE BROKE OFF AND REMAINED IN THE PATIENT. DR DID NOTE POSSIBLE THE WIREGUIDE WAS LOOPED ABOVE THE ZILVER PRIOR TO DEPLOYMENT. THE ZILVER STENT IS NOW IN AN UNDESIRED POSITION AND CONERTINAED. DR ATTEMPTED TO REMOVE THE ZILVER BUT IT SEEM TO FRACTURE. HE THEN PLACED

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292783 ↗
• MalfunctionFeb 26, 2020Off-Label Use; Off-Label Use

  THIS IS A CANCELLATION MDR AS OFF-LABEL USE OF THE DEVICE (SIDE-BY-SIDE) IS NOT LICENCED IN JAPAN ONLY. THE SIDE-BY-SIDE STENTING IS NOT OFF-LABEL WITHIN THE US.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9755853 ↗
• MalfunctionFeb 26, 2020Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  THE CUSTOMER PLANNED TO PLACE A 8MM-12CM STENT IN EACH OF THE RIGHT B5, B6 AND THE LEFT B3 TO THE HEPATIC PORTAL REGION. FIRSTLY, HE REMOVED AN ENBD CATHETER THAT HAD BEEN PLACED IN THE RIGHT B5 AND A ERBD CATHETER THAT HAD BEEN PLACED IN THE LEFT B3. THEN HE CHECKED THE LENGTH OF STENOSED SITE BY ANGIOGRAPHY. THEN HE PLACED GUIDE WIRES IN B5, B6 AND B3. HE THEN PLACED A STENT IN B5 AND B3 SUCCESSFULLY USING SBS TECHNIQUE. HE THEN ADVANCED A WIRE GUIDE TO B6 THROUGH THE MESH OF THE STENT THAT WAS PLACED IN B5 AND ADVANCED THE DELIVERY SYSTEM OF ZILBS-635-8-12(LOT# C1600624) OVER THE WIRE GUIDE. HOWEVER THE DELIVERY SYSTEM WOULD NOT GO THROUGH THE MESH, SO HE REMOVED THE DELIVERY SYSTEM FROM THE ENDOSCOPE TO DILATE THE MESH. HE THOUGHT WHOLE DELIVERY SYSTEM WAS REMOVED BUT FOUND THE TIP WAS SEPARATED FROM THE DELIVERY SYSTEM AND LEFT IN THE ENDOSCOPE TIP. HE REMOVED THE TIP USING GRASPING FORCEPS SUCCESSFULLY. ANOTHER ZILBS-635-8-12(LOT# UNKNOWN) WAS USED INSTEAD AND THE STENT WAS PLACED IN B6 TO COMPLETE THE PROCEDURE. ADDITIONAL EXPLANATION FOR THE DEVICES USED FOR THIS PROCEDURE: ASUKA HAMADA@CJ 06/FEB/2020. ZILBS-635-8-12 (C1519479) WAS PLACED IN B5 USING SBS TECHNIQUE WITH ZILB

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9755824 ↗
• MalfunctionFeb 26, 2020Failure to Advance; Failure to Advance

  THE CUSTOMER PLANNED TO PLACE A 8MM-12CM STENT IN EACH OF THE RIGHT B5, B6 AND THE LEFT B3 TO THE HEPATIC PORTAL REGION. FIRSTLY, HE REMOVED AN ENBD CATHETER THAT HAD BEEN PLACED IN THE RIGHT B5 AND A ERBD CATHETER THAT HAD BEEN PLACED IN THE LEFT B3. THEN HE CHECKED THE LENGTH OF STENOSED SITE BY ANGIOGRAPHY. THEN HE PLACED GUIDE WIRES IN B5, B6 AND B3. HE THEN PLACED A STENT IN B5 AND B3 SUCCESSFULLY USING SBS TECHNIQUE. HE THEN ADVANCED A WIRE GUIDE TO B6 THROUGH THE MESH OF THE STENT THAT WAS PLACED IN B5 AND ADVANCED THE DELIVERY SYSTEM OF ZILBS-635-8-12(LOT# C1600624) OVER THE WIRE GUIDE. HOWEVER THE DELIVERY SYSTEM WOULD NOT GO THROUGH THE MESH, SO HE REMOVED THE DELIVERY SYSTEM FROM THE ENDOSCOPE TO DILATE THE MESH. HE THOUGHT WHOLE DELIVERY SYSTEM WAS REMOVED BUT FOUND THE TIP WAS SEPARATED FROM THE DELIVERY SYSTEM AND LEFT IN THE ENDOSCOPE TIP. HE REMOVED THE TIP USING GRASPING FORCEPS SUCCESSFULLY. ANOTHER ZILBS-635-8-12(LOT# UNKNOWN) WAS USED INSTEAD AND THE STENT WAS PLACED IN B6 TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9755661 ↗