Zilver 635Recalls & reported problems across all models
Cook Ireland Ltd · 55 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 296
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls
- 0
We found 55 models of Zilver 635 by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 296 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2016 and Jun 2, 2026 — classified as 47 injuries, 249 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (66 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Zilver 635 problems
Device problems
- Activation, Positioning or Separation Problem66
- Break53
- Improper or Incorrect Procedure or Method51
- Off-Label Use41
- Fracture29
- Premature Activation25
- Delivery System Failure22
- Activation Failure19
Patient problems
- No Clinical Signs, Symptoms or Conditions134
- No Consequences Or Impact To Patient85
- No Known Impact Or Consequence To Patient81
- Foreign Body In Patient11
- Obstruction/Occlusion4
- Unintended Radiation Exposure4
- Abdominal Pain3
- Itching Sensation3
Zilver 635 models
55 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zilver 635 G50624CATHETER, BILIARY, DIAGNOSTIC70 reports
- Zilver 635 G50621CATHETER, BILIARY, DIAGNOSTIC35 reports
- Zilver 635 G50623CATHETER, BILIARY, DIAGNOSTIC33 reports
- Zilver 635 G50620CATHETER, BILIARY, DIAGNOSTIC15 reports
- Zilver 635 G50622CATHETER, BILIARY, DIAGNOSTIC14 reports
- Zilver 635 G23813Stents, drains and dilators for the biliary ducts7 reports
- Zilver 635 G23814Stents, drains and dilators for the biliary ducts6 reports
- Zilver 635 G23815Stents, drains and dilators for the biliary ducts6 reports
- Zilver 635 G43823STENT, ILIAC6 reports
- Zilver 635 G23816Stents, drains and dilators for the biliary ducts5 reports
- Zilver 635 G43826STENT, ILIAC5 reports
- Zilver 635 G43858STENT, ILIAC5 reports
- Zilver 635 G43867STENT, ILIAC5 reports
- Zilver 635 G43868STENT, ILIAC5 reports
- Zilver 635 G50618CATHETER, BILIARY, DIAGNOSTIC5 reports
- Zilver 635 G23812Stents, drains and dilators for the biliary ducts4 reports
- Zilver 635 G36013Stents, drains and dilators for the biliary ducts4 reports
- Zilver 635 G50619CATHETER, BILIARY, DIAGNOSTIC4 reports
- Zilver 635 G36229CATHETER, BILIARY, DIAGNOSTIC3 reports
- Zilver 635 G36246CATHETER, BILIARY, DIAGNOSTIC3 reports
- Zilver 635 G43832STENT, ILIAC3 reports
- Zilver 635 G43833STENT, ILIAC3 reports
- Zilver 635 G43843STENT, ILIAC3 reports
- Zilver 635 G43861STENT, ILIAC3 reports
- Zilver 635 G50617CATHETER, BILIARY, DIAGNOSTIC3 reports
- Zilver 635 G31486Stents, drains and dilators for the biliary ducts2 reports
- Zilver 635 G32006Stents, drains and dilators for the biliary ducts2 reports
- Zilver 635 G36009Stents, drains and dilators for the biliary ducts2 reports
- Zilver 635 G36239CATHETER, BILIARY, DIAGNOSTIC2 reports
- Zilver 635 G36245CATHETER, BILIARY, DIAGNOSTIC2 reports
- Zilver 635 G43821STENT, ILIAC2 reports
- Zilver 635 G43841STENT, ILIAC2 reports
- Zilver 635 G43851STENT, ILIAC2 reports
- Zilver 635 G43856STENT, ILIAC2 reports
- Zilver 635 G43857STENT, ILIAC2 reports
- Zilver 635 G43866STENT, ILIAC2 reports
- Zilver 635 G23811Stents, drains and dilators for the biliary ducts1 report
- Zilver 635 G32032CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G32033CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G36021CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G36230CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G36235CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G36236CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G36238CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G36240CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G36241CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G36244CATHETER, BILIARY, DIAGNOSTIC1 report
- Zilver 635 G43827STENT, ILIAC1 report
- Zilver 635 G43828STENT, ILIAC1 report
- Zilver 635 G43831STENT, ILIAC1 report
- Zilver 635 G43848STENT, ILIAC1 report
- Zilver 635 G43850STENT, ILIAC1 report
- Zilver 635 G43862STENT, ILIAC1 report
- Zilver 635 G43863STENT, ILIAC1 report
- Zilver 635 G50616CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Zilver 635 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Premature Activation
AFTER INSERTING THE ZILVER STENT DELIVERY SYSTEM INSIDE THE CBD , WHILE ASSESING THE LENGTH OF THE STRICTURE AND STENT , IT WAS FOUND THE THERE IS NEED OF 8CM STENT INSTEAD OF 6CM.WHILE REMOVING THE ZILVER 6CM STENT, IT GOT AUTOMATICALLY DEPLOYED TILL HALF POINT WITHOUT EVEN REMOVING THE SAFETY LOCK. PATIENT/EVENT INFO - NOTES DO THEY KNOW WHY THE STENT GOT PREMATURELY DEPLOYED DURING RETRACTION? NO. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? OLYMPUS 150 SERIES ERCP SCOPE ACCESORY CHANNEL SIZE 4.2MM. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? VISIGLIDE .35. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? NO. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? NO. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? 8CM ZILVER DEPLOYED AT SAME TIME IN SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360790 ↗MalfunctionJun 2, 2026Dent in Material
THROUGH THE ENDOSCOPIC CHANNEL, THE STENT WAS GUIDED ALONG THE ACRO WIRE GUIDE TO THE COMMON BILE DUCT. AFTER A LONG EFFORT, IT WAS UNABLE TO CROSS THE STENOSIS AREA. USER RETRACTED THE DEVICE FROM PATIENT, IT WAS FOUND THAT THE TIP OF THE STENT WAS BENT AND UNUSABLE. DURING THE CLEANING PROCESS, THE STENT WAS ACCIDENTALLY RELEASED, AND THE KINK INSIDE THE STENT WERE CLEARLY VISIBLE. SUCCESSFULLY COMPLETED THE PROCEDURE BY CHANGING TO ANOTHER SAME RPN DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25358719 ↗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 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 ↗MalfunctionMar 30, 2026Fracture
DURING THE DEPLOYMENT OF ZILVER STENT BROKEN. ZILVER METAL STENT'S PART REMAIN INSIDE OF THE PATIENT. (B)(6) 2026 (SAME TIME) BILIARY PLASTIC STENT DEPLOYED. 1. PLEASE PROVIDE THE TRACKING INFORMATION FOR THE RETURNED DEVICE. ANS: YET NOT COURIER. 2. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? ANS: 4.2MM 3. WHAT WAS THE TARGET LOCATION OF THE STENT? ANS: CBD 4. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? ANS: VISIGLIDE WIRE 0.025 5. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLEDOCHOJEJUNOSTOMY)) ANS: CHOLEDOCHOJEJUNOSTOMY ANATOMY. 6. 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) ANS: NOT NOTICED. 7. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? ANS: SAME PROCEDURE. 8. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? (IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED?) ANS
Patient problems: Foreign Body In Patient
MAUDE report 24714225 ↗MalfunctionMar 24, 2026Improper or Incorrect Procedure or Method
THE ZILBS-635-10-10 WAS ADVANCED VIA THE PAPILLA TOWARD THE HILAR BILE DUCT; HOWEVER, IT WAS UNABLE TO CROSS THE STRICTURE. A NON-COOK STENT WAS PLACED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON 26FEB2026: WAS THERE ANY EVIDENCE THAT THE SHEATH/CATHETER BEING KINKED WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT? NO. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? 3.7MM (OLYMPUS, JF-260V). DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? ALREADY PROVIDED IN OTHER NON-COOK PRODUCTS (FIELDER 025, 025INCH GW). DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? NO. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? NO. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY OR AROUND A TIGHT ANGLE IN AN ENDOSCOPE? NONE OTHER THAN THE REPORTED STRICTURE. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO RESISTANCE WAS ENCOUNTERED UNTIL THE REPORTED STRICTURE. IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED? NA. WHAT WAS THE POSITION OF THE ELEVATOR DURING ADVANCEMENT? IT WAS SET TO OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673192 ↗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 ↗InjuryJan 12, 2026Off-Label Use
IT WAS REPORTED THAT AFTER THE STENT WAS DEPLOYED DURING A VENOUS STENT PLACEMENT, A PIECE OF THE INNER CATHETER BROKE OFF. THEY USED A SNARE TO PULL OUT THE PIECE OF THE BROKEN CATHETER. THERE WAS NO DELAY OR ADDITIONAL PROCEDURE. NO REPORTED ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24034674 ↗InjuryJan 9, 2026Off-Label Use
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 17-FEB-2026. AFTER DEPLOYING THE STENT, A PIECE OF THE INNER CATHETER BROKE OFF. THEY USED A SNARE TO PULL OUT THE PIECE OF THE BROKEN CATHETER. 1. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6 FRENCH BUT NOT SURE OF THE EXACT NAME. 2. WHAT WAS THE TARGET LOCATION FOR THE STENT? NOT ANSWERED. 3. CAN YOU PLEASE CLARIFY WHAT PIECE OF THE INNER CATHETER BROKE OFF? IF YOU CAN SHARE A IMAGE, IT WILL BE VERY HELPFUL FOR INVESTIGATION. VENOUS SINUS. THE INNER WIRE CANNULA BROKE. 4. DID THE USER OBSERVE ANY ISSUE THAT MAY CAUSE THIS TO HAPPEN? NO. 5. WAS THE DEVICE USED PERCUTANEOUSLY? YES. 6. WHAT WAS THE ACCESS SITE CHOSEN? FEMORAL VEIN. 7. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? .035 BENTSON. 8. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. 9. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED, CALCIFIED, FIBRIOTIC)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE). VERY TORTUOUS. 10. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? N/A, ISPILATERAL, CONTRALATERAL (IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, YES, NO). N/A. 11. WERE A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027293 ↗MalfunctionJan 9, 2026Failure to Advance; Material Twisted/Bent
USER OPENED THE PACKAGE AND INJECTED WATER, THEN ADVANCED THE DELIVERY SYSTEM THROUGH WIRE GUIDE WHILE FOUND OUT THE WIRE GUIDE CANNOT BE PUT THROUGH DELIVERY SYSTEM. USER RETRACTED THE DEVICE AND CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE 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. CAN YOU PROVIDE THE TRACKING INFORMATION FOR THE RETURNED DEVICE? YES. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? 4.2. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? YES. WHAT WAS THE TARGET LOCATION OF THE STENT? LEFT HEPATIC DUCT DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? ACRO-35-450. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE (E.G., CHOLODOCHOJEJUNOSTOMY)) NO. 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)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016853 ↗MalfunctionJan 9, 2026Dent in Material; Activation Failure
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 04-FEB-26.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016833 ↗MalfunctionDec 24, 2025Premature Activation; Premature Activation
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 04-FEB-26.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23887660 ↗InjuryNov 14, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT THE STENT FRACTURED AND FELL INTO THE INTESTINAL LUMEN ONE YEAR AFTER PLACEMENT, CAUSING INTESTINAL OBSTRUCTION, NECESSITATING PARTIAL ILEAL RESECTION. ON (B)(6) 2025: SEPARATION OF ABDOMINAL ADHESIONS AND PARTIAL ILEAL RESECTION. COMMUNICATION WITH PRODUCT MANAGER WHO MENTIONED THE PATIENT AND FAMILY WANTS COMPENSATION DUE TO THIS EVENT (STENT BROKEN), NO OFFICIAL REQUEST SO FAR FROM DISTRIBUTOR/USER FACILITY. PROCEDURE DETAIL UPDATED ON (B)(6) 202056 FROM AN IMAGE FROM USER FACILITY COMPUTER SCREEN: DIAGNOSIS: 1. TERMINAL ILEAL ADHESION TORSION WITH SMALL BOWEL STENT FOREIGN BODY CAUSING ACUTE INTESTINAL OBSTRUCTION 2. HIGH LIKELIHOOD OF DISTAL COMMON BILE DUCT CARCINOMA 3. HYPOKALEMIA 4. STAGE 1 HYPERTENSION (MODERATE RISK) 5. MULTIPLE CYSTS IN LEFT HEPATIC LOBE 6. LEFT RENAL CYST? 7. HYPOPROTEINEMIA 8. BRADYCARDIA; 9. POSTOPERATIVE STATUS: BILIARY ASCARIASIS, CHOLECYSTECTOMY, HYSTERECTOMY, BILIARY STENT PLACEMENT, PANCREATIC DUCT STENT PLACEMENT; 10. MULTIPLE SMALL NODULES IN BOTH LUNGS; 11. LUMBAR SCOLIOSIS; 12. BILIARY DISTENSION SYNDROME - LIVER QI STAGNATION. PROCEDURE NAME: LAPAROSCOPIC PARTIAL ILEAL RESECTION + LAPAROSCOPIC ADHESIOLYSIS + LAPAROSCOPIC
Patient problems: Foreign Body In Patient
MAUDE report 23559695 ↗MalfunctionOct 28, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-NOV-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401775 ↗MalfunctionSep 30, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure
NURSE OPENED THE PACKAGE AND FLUSH WITH WATER, THEN ADVANCED THE STENT DELIVERY SYSTEM THROUGH WIRE GUIDE AND ENDOSCOPE TO BILE DUCT DESIRED POSITION, DURING STENT RELEASING USER DETECTED THE STENT CANNOT BE DEPLOYED. USER RETRACTED THE STENT DELIVERY SYSTEM FROM ENDOSCOPE AND FOUND OUT THERE IS WIRE LIKE MATERIAL OUT OF FROM THE TIP OF DELIVERY SYSTEM. USER CHANGED TO A NEW DEVICE WITH SAME RPN TO COMPLETE THE PROCEDURE. "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."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23178831 ↗
Other Cook Ireland Ltd products
All Cook Ireland Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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