Zilver 635 G50620Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10827002506203), received between Apr 12, 2016 and Mar 30, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Dent in Material

  AFTER THE NURSE OPENED THE PACKAGE AND FLUSHED THE SYSTEM WITH STERILE WATER, THE ZILBS-635-8-6 STENT DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDEWIRE THROUGH THE DUODENOSCOPE AND POSITIONED IN THE COMMON BILE DUCT. WHEN THE OPERATOR ATTEMPTED TO DEPLOY THE STENT, THE PUSHER COULD NOT BE ADVANCED AND THE STENT WOULD NOT RELEASE. THE ASSEMBLY WAS WITHDRAWN FROM THE SCOPE, AND A KINK WAS OBSERVED AT THE DISTAL (LEADING) TIP. A NEW DEVICE OF THE SAME RPN WAS INTRODUCED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." WHAT ENDOSCOPE CHANNEL SIZE WAS USED? 3.7. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? METII-35-480. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHOJEJUNOSTOMY). NO. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? (IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715287 ↗
• MalfunctionFeb 5, 2026Premature Activation

  IT DEPLOYED PREMATURELY, PRIOR TO HANDLE BEING UNLOCKED. UPDATED AS PER COMPLAINT FORM RECEIVED ON 15/1/2026: THE STENT WAS VISUALIZED AS PARTIALLY DEPLOYED UPON EXITING SCOPE AND PRIOR TO INSERTION INTO CBD. THE STENT LOCK WAS STILL IN PLACE. STAFF WERE HIGHLY EXPERIENCED AND FAMILIAR WITH THIS PRODUCT. ADDITIONAL QUESTIONS RECEIVED ON 15-JAN-2026. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? DUODENOSCOPE 4.6MM. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A. NO ZIP PORT ON A ZILBS-635. WHAT WAS THE TARGET LOCATION OF THE STENT? BILE DUCT. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? AWG2-35-450. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHOJEJUNOSTOMY)) WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED) IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A IN THIS CASE. WAS THE RED SAFETY LOCK REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270284 ↗
• MalfunctionNov 17, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 10-JUN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158787 ↗
• MalfunctionMar 23, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED 13-APR-2023 AND THE COMPLETION OF THE INVESTIGATION ON THE 18-APR-2023. ADDITIONAL INFORMATION RECEIVED 13-APR-2023: ADDITIONAL QUESTIONS ANSWERED 'DEVICES WERE PLACED SIDE BY SIDE' USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596152 ↗
• MalfunctionDec 21, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13050614 ↗
• MalfunctionNov 29, 2021Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE DEVICE EVALUATED ON 10-DEC-21: "SHEATH KINKED. STENT PARTIALLY DEPLOYED WITH RED SAFETY LOCK IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882995 ↗
• MalfunctionOct 22, 2020Premature Activation; Premature Activation

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE HAVING BEEN CARRIED OUT. 05OCT2020 (B)(6) UPDATED. THE COMPLAINED DEVICE WAS DELIVERED TO THE PORTA HEPATIS BUT THE USER WAS UNABLE TO ADVANCE THE DEVICE FURTHER MORE DUE TO STRONG STRICTURE. DURING SOME ATTEMPTS TO ADVANCE THE DEVICE IN THE STRICTURE, THE TIP OF THE STENT(1 CM) WAS DEPLOYED UNINTENTIONALLY EVEN THOUGH THE SAFETY LOCK WAS NOT UNLOCKED. THE USER WAS UNABLE TO RETRIEVE THE STENT INTO THE SHEATH, SO HE HAD TO FULLY DEPLOY THE STENT IN A UNINTENTDED PLACE. ANOTHER STENT WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. PATIENT/EVENT INFO - NOTES: 06OCT2020 (B)(6) UPDATED. [USER'S COMMENT]. IT WAS DIFFICULT TO ADVANCE THE DELIVERY SYSTEM DUE TO STRONG STRICTURE. I DID NOT UNLOCK THE SAFETY LOCK BUT THE STENT WAS DEPLOYED, SO THE DEVICE MAY HAVE A PROBLEM. 02OCT2020 (B)(6) . QUESTIONS BEING ASKED TO THE REP: 1.WAS THE STENT DEPLOYED COMPLETELY OR PARTIALLY? PARTIALLY. 2.HOW WERE THE STENT AND THE DELIVERY SYSTEM REMOVED FROM THE BODY? PLEASE DESCRIBE IN MORE DETAIL AFTER THE STENT WAS DEPLOYED. SEE THE DESCRIPTION OF EVEN

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

  MAUDE report 10721828 ↗
• MalfunctionSep 9, 2019Fracture; Fracture

  USER FOUND OUT THE OUTER SHEATH WAS DETACHED NEAR HANDLE WHILE ADVANCING THE DEVICE THROUGH WIRE GUIDE. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR BREAKING (INCL. FLEXOR/HANDLE SEPARATION)¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8974191 ↗
• InjuryJul 16, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE STENT PREMATURELY RELEASED 0.5CM DURING ADVANCING THE DELIVERY SYSTEM IN BILE DUCT. THE DEVICE WAS LOCKED BEFORE ADVANCING ENDOSCOPY. USER IS AN EXPERIENCED OPERATOR OF COOK DEVICE. ADDITIONAL INFORMATION PROVIDED ON 12TH JULY 2019: PATIENT FELT UPPER RIGHT ABDOMEN DISCOMFORT AND XANTHOCHROMIA IN (B)(6) 2019 AND WENT TO HOSPITAL FOR EXAMINATION. THE RESULT OF EXAMINATION IS AS BELOW: THICKENED BOTTOM WALL OF GALLBLADDER, INCREASED METABOLISM, CONSIDERING PRIMARY MALIGNANT TUMOR OF GALLBLADDER, MULTIPLE HILAR AND RETROPERITONEAL LYMPH NODE ENLARGEMENT, ACCOMPANIED BY INCREASED METABOLISM, CONSIDERING LYMPH NODE METASTASIS, LEFT UPPER LOBE ROUND NODULES, INCREASED METABOLISM, CONSIDERING LUNG METASTASIS. THE HIGHEST BILIRUBIN WAS OVER 100, AND PTCD DRAINAGE WAS PERFORMED IN THE LOCAL HOSPITAL. MEANWHILE, PATHOLOGICAL EXAMINATION WAS COMPLETED TO SHOW MUCINOUS ADENOCARCINOMA.THE TOTAL BILIRUBIN WAS 70, DIRECT BILIRUBIN 49, AND TRANSAMINASE WAS NORMAL. ERCP WAS PERFORMED IN (B)(6) 2019, AND METAL BILIARY STENTS WERE IMPLANTED IN THE LEFT AND RIGHT HEPATIC DUCTS. THE COMPLAINT IS RELATED WITH (B)(4) WITH THE SAME PATIENT. (B)(4) IS THE FIRST STENT RELEASED WITH STENT PREMATURELY REL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793631 ↗
• MalfunctionDec 17, 2018Separation Problem; Separation Problem

  BILIARY STENT PLACEMENT WAS PERFORMED FOR THE PATIENT WHO HAS HEPATIC PORTAL REGION CANCER. THE SHEATH SEPARATED FROM THE HANDLE. THEREFORE, THE USER HELD AND PULLED THE SHEATH TO DEPLOY THE STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8168567 ↗
• MalfunctionAug 24, 2018Break; Break

  BILIARY STENT PLACEMENT FOR HEPATIC PORTAL REGION CANCER WAS CONDUCTED. DUE TO CANCER INVASION, THE POSITION OF THE ENDOSCOPE WAS UNSTABLE SINCE IT WAS UNABLE TO STRETCH THE SCOPE. THE CUSTOMER ADVANCED THE DELIVERY SYSTEM TO THE TARGET SITE AND ATTEMPT TO DEPLOY THE STENT BUT THE SHEATH SEPARATED FROM THE HANDLE RIGHT AFTER HE STARTED TO PULL THE SHEATH. HE COULD NOT CONFIRM IF THE STENT "PARTIALLY" CAME OUT OF THE SHEATH TIP BUT HE SUCCEEDED TO PULL THE DEVICE OUT FROM THE ENDOSCOPE. HE USED THE DIFFERENT DEVICE INSTEAD AND PLACED THE STENT SUCCESSFULLY AND COMPLETED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812140 ↗
• MalfunctionApr 23, 2018Delivery System Failure; Delivery System Failure

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION". AS REPORTED TO CUSTOMER RELATIONS, "ON THURSDAY (B)(6) AT APPROXIMATELY 6:30 PM TECH (B)(6) AND DR. (B)(6) WERE COMPLETING THE SECOND PLACEMENT OF A BI HILAR METAL STENT CASE. THE FIRST STENT WAS PLACED IN THE LEFT HEPATIC, THEN THE DOCTOR WENT IN WITH THE SECOND ZILVER 635. THE SECOND WAS PLACED INSIDE THE FIRST AND THROUGH THE A CELL UP INTO THE RIGHT HEPATIC. DURING DEPLOYMENT THE TECH HEARD A LOUD POP, SHE NOTICED THE CATHETER HAD BROKEN FREE FROM THE DEPLOYMENT DEVICE AND SHE COULD NO LONGER DEPLOY. THE DOCTOR GRABBED THE DEVICE AND SOMEHOW GOT THE STENT TO DEPLOY MANUALLY. THE STENT PLACEMENT WAS GREAT AND THERE WERE NO COMPLICATIONS TO THE PATIENT. I OBTAINED THE DEVICE AND WILL SEND FOR INVESTIGATION. THIS FACILITY HAS PLACED MANY ZILVER 635 IN THE PAST AND THE DOCTOR IS VERY SKILLED. TO DATE I'VE ONLY SPOKEN TO THE TECH, BUT WILL BE MEETING WITH THE DR. TOMORROW AND WILL ACQUIRE ANY FURTHER NEEDED INFORMATION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450699 ↗
• MalfunctionMar 8, 2018Delivery System Failure; Delivery System Failure

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)¿. TO PLACE A METALLIC STENT IN THE MALIGNANT STRICTURE OF HEPATIC PORTAL REGION, THE USER ADVANCED THE DELIVERY SYSTEM BUT IT WOULD NOT PASS THROUGH THE STENOSED LESION. SO HE DILATED THE STENOSED LESION USING AN EPBD BALLOON CATHETER AND A DILATOR AND TRIED AGAIN, BUT THE DELIVERY SYSTEM WOULD NOT PASS THROUGH THE STENOSED LESION. AFTER SEVERAL ATTEMPT, ONLY THE OUTER SHEATH ADVANCED FORWARD AS COVERING THE INNER CATHETER TIP, SO HE REMOVED AND REPLACED IT WITH ANOTHER ZILVER 635 BILIARY SELF EXPANDING METAL STENT TO COMPLETE THE PROCEDURE. THE USER COMMENTED THAT THE STENOSIS WAS SEVERE, BUT HE HAS NEVER EXPERIENCED THIS PHENOMENON BEFORE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322978 ↗
• InjuryAug 1, 2017Fracture; Fracture

  THE USER ADVANCED THE DEVICE TO DESIRED POSITION IN COMMON BILE DUCT AND DEPLOYED THE STENT. THEY USED GRASPING FORCEPS TO ADJUST THE LOCATION OF STENT. THEY SAID THAT THE STENT WAS DETACHED. THEY WITHDREW PART OF DEVICE, BUT DETACHED PART OF STENT WAS LEFT INSIDE PATIENT BODY. THEN THE USER ADVANCED ANOTHER DEVICE AND DEPLOYED THE STENT. UPDATED ON 25-JUL-2017: WHY WAS THE PHYSICIAN ATTEMPTING THE REPOSITION THE STENT? THE PATIENT HAS DUODENAL PAPILLARY STENOSIS. THE STENT WAS RETRACTION TO DUODENAL PAPILLA AFTER THE USER DEPLOYED THE STENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6756240 ↗
• InjuryApr 12, 2016Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2015 : ZILBS-635-8-6 (C1074459) WAS PLACED IN COMMON BILE DUCT. DATE UNKNOWN:RESTENOSIS WAS OBSERVED DUE TO STENT INGROWTH. ON (B)(6) 2016 : RE-INTERVENTION PERFORMED AGAINST STENT RESTENOSIS DUE TO STENT INGROWTH. AFTER IMAGING, THE USER PLANNED TO PLACE ANOTHER ZILBS-635-8-6 OVER THE PLACED STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5569894 ↗