Evolution G23128Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10827002231280), received between Apr 7, 2016 and Aug 11, 2026 — classified as 30 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205892 ↗
• MalfunctionMay 18, 2026Deformation Due to Compressive Stress; Activation Failure

  UNABLE TO RETRIEVE THE PROSTHESIS FROM THE WEARER. PROBLEM ENCOUNTERED WHEN RELEASING THE PROSTHESIS; IMPOSSIBLE TO RELEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207387 ↗
• MalfunctionJan 7, 2026Material Twisted/Bent; Activation Failure

  AS REPORTED TO CUSTOMER RELATIONS. "IN AN ERCP PROCEDURE WITH PLACEMENT OF A PARTIALLY COVERED BILIARY STENT, IT DID NOT FIRE AT THE TIME OF ITS USE." NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986812 ↗
• MalfunctionOct 23, 2025Break; Break

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 14-NOV-2025. RECEIVED 28OCT2025. 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? · DURING STENT PLACEMENT. 2. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? - NO. 3. WERE ANY DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO. - NO. 4. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. STRICTURE INFORMATION: 1. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? - 3 CM. 2. WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THROUGH STRICTURE? N/A, YES, NO - NO. 3. WAS THERE RESISTANCE FELT PASSING THE EVOLUTION THROUGH STRICTURE? N/A, YES, NO - NO. 4. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? N/A YES, NO - NO. QUESTIONS RELATED TO DURING INSERTION INTO PATIENT: 1. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? N/A, YES, NO - NO. 2. WAS RESISTANCE FELT DURING INSERTION INTO PATIENT? N/A, YES, NO - NO. 3. IF YES, AT WHAT POINT? (B)(6) 2025. YES, THE INTRODUCER WAS CUT TO SAFELY REMOVE IT FROM THE ENDOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366373 ↗
• MalfunctionSep 25, 2025Device Damaged Prior to Receipt by User; Material Twisted/Bent; Device Damaged Prior to Receipt by User; Material Twisted/Bent

  WHEN THE PROSTHESIS WAS OPENED, IT WAS BROKEN. : THE OPENING WAS EMPTY AND THE GUN DID NOT ACTIVATE THE MECHANISM CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151808 ↗
• InjuryDec 11, 2024Off-Label Use; Off-Label Use

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 16-JAN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 20901929 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTAL CORRECTION REPORT BEING SUBMITTED ON 08-JAN-2025 TO UPDATE RPN AND LOT # TO UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20828478 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE TO UPDATE DEVICE AND LOT NUMBER TO UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20817996 ↗
• MalfunctionDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 09-JAN-2025.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20817857 ↗
• InjuryDec 2, 2024Adverse 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 (B)(6)2025.

  Patient problems: Abdominal Pain; Obstruction/Occlusion

  MAUDE report 20817834 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE (UPDATE DEVICE AND LOT NUMBER TO UNKNOWN) ON (B)(6)2025.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20817335 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2016 DATE OF FIRST IMPLANT PROCEDURE IN COMMON BILE DUCT. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. NOT DOCUMENTED IF FLUOROSCOPIC MONITORING WAS USED. FOR PANCREATIC CANCER. NO ADVERSE EVENTS RELATED TO PROCEDURE RE-CURRENT BILIARY OBSTRUCTIONS 03-NOV-2017. DUE TO CANCER AND STENOSIS. INTERVENTION PERFORMED 330 DAYS POST PROCEDURE. TREATMENT OF NEW STUDY STENT INSIDE STENT. THE SITE DETERMINED THE EVENT NOT TO BE RELATED TO THE STUDY DEVICE OR THE PROCEDURE. PATIENT DEATH (B)(6) 2018 UNKNOWN CAUSE OF DEATH. THE REINTERVENTION WAS NOTED TO BE SUCCESSFUL. ON (B)(6) 2018, THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20789658 ↗
• InjuryNov 26, 2024Adverse 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 02-DEC-24.

  Patient problems: Abdominal Pain; Obstruction/Occlusion

  MAUDE report 20787854 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 02-DEC-2024.

  Patient problems: Itching Sensation; Nausea; Obstruction/Occlusion

  MAUDE report 20785918 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2019 DATE OF FIRST IMPLANT PROCEDURE IN CBD. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. NOT DOCUMENTED IF FLUOROSCOPY WAS USED. CHEMOTHERAPY RECEIVED (B)(6) 2017 TO (B)(6) 2018. RE-CURRENT BILIARY OBSTRUCTIONS (B)(6) 2020. AT 11 DAYS POST-PROCEDURE. DUE TO FOOD IMPACTION. PATIENT PRESENTED WITH NAUSEA. TREATMENT ENDOSCOPIC INTERVENTION NEW STENT INSIDE STUDY STENT AND ANTIBIOTICS. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE OR PROCEDURE. PATIENT DEATH (B)(6) 2021. PATIENT OUTCOME: THE REINTERVENTION WAS NOTED TO BE SUCCESSFUL. ON (B)(6) 2021, THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN. DASH SPHINCTEROTOME USED.

  Patient problems: Nausea; Obstruction/Occlusion

  MAUDE report 20785603 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2017 DATE OF FIRST IMPLANT PROCEDURE NOT DOCUMENTED WHERE. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. NOT DOCUMENTED IF FLOUROSCOPY WAS USED. CHEMOTHERAPY RECEIEVED (B)(6) 2017 TO (B)(6) 2018. RE-CURRENT BILIARY OBSTRUCTIONS (B)(6) 2017. AT 273 DAYS POST-PROCEDURE. DUE TO TISSUE OR TUMOR INGROWTH. NO SIGNS/SYMPTOMS. TREATMENT ENDOSCOPIC INTERVENTION NEW STENT INSIDE STUDY STENT AND ANTIBIOTICS. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE OR PROCEDURE. PATIENT DEATH (B)(6) 2018. THE REINTERVENTION WAS NOTED TO BE SUCCESSFUL. ON (B)(6) 2018, THE PATIENT DIED. THE CAUSE OF DEATH WAS PRIMARY DISEASE PROGRESSION. DASH SPHINCTEROTOME USED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20785081 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-DEC-2024.

  Patient problems: Abdominal Pain; Obstruction/Occlusion; Vomiting

  MAUDE report 20784859 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2019 DATE OF FIRST IMPLANT PROCEDURE IN COMMON BILE DUCT. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. NOT DOCUMENTED IF FLOUROSCOPY WAS USED. RE-CURRENT BILIARY OBSTRUCTIONS (B)(6) 2019. AT 37 DAYS POST-PROCEDURE. DUE TO TISSUE OR TUMOR INGROWTH. PATIENT PRESENTED WITH NAUSEA AND VOMITING. TREATMENT ENDOSCOPIC INTERVENTION NEW STENT INSIDE STUDY STENT AND ANTIBIOTICS. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE OR PROCEDURE. PATIENT DEATH (B)(6) 2020. THE REINTERVENTION FOR BILIARY OBSTRUCTION WAS NOTED TO BE SUCCESSFUL. ON (B)(6) 2020, THE PATIENT DIED. THE CAUSE OF DEATH WAS ANGIOCHOLITIS. DASH SPHINCTEROTOME USED.

  Patient problems: Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 20784520 ↗
• InjuryNov 26, 2024Adverse 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 06-DEC-2024.

  Patient problems: Abdominal Pain; Itching Sensation; Obstruction/Occlusion; Vomiting

  MAUDE report 20783646 ↗
• MalfunctionAug 16, 2024Material Twisted/Bent; Material Twisted/Bent

  THE STENT BEGAN TO RELEASE CORRECTLY AND WHEN IT HAD ONLY DEPLOYED ABOUT 10 MM IT COULD NOT BE OPENED FURTHER. THEY REMOVED THE ENTIRE SYSTEM, ALONG WITH THE STENT, AND THEY IMPLANTED ANOTHER STENT. 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. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? DUODENOSCOPE 4.2. WHAT WAS THE POSITION OF THE ELEVATOR? OPEN. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? JAGWIRE 0.035. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. BILE DUCT. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? 5 MINUTES, WHEN IT CAN NO LONGER BE RELEASED, IT RETREATS ENTIRELY. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997801 ↗
• MalfunctionMay 27, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DESCRIPTION OF EVENT: IMPOSSIBILITY TO RELEASE THE BILIARY PROST ONCE IN PLACE. AFTER REMOVAL OF THE DEVICE, WE FOUND THAT THE SHEATH IS DAMAGED, INSTALLATION OF ANOTHER PROTHESIS WITHOUT PROBLEM PATIENT OUTCOME: 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/EVENT INFO - NOTES: 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR, DURING STENT PLACEMENT. 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? NA. 3. WHAT WAS THE POSITION OF THE ELEVATOR? N/A. 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)?NA. 5. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A. 6. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? N/A, 7. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. 8. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? 9. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETED? N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400463 ↗
• MalfunctionOct 17, 2023Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  PER REP - 19SEP2023 - THE STENT WOULD NOT DEPLOY. IT MADE A POP SOUND WHEN TRYING TO DEPLOY IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BOSTON SCIENTIFIC STENT. 2.0 RPN PREFIX: EVO; 2.1 GENERAL QUESTIONS: 2.1.1 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? (WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL) -WHILE TRYING TO DEPLOY; 2.1.2 WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? -OLYMPUS Q190V, 4.2; 2.1.3 WHAT WAS THE POSITION OF THE ELEVATOR? N/A, OPEN, CLOSED -UNKR; 2.1.4 DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? -.035 JAG WIRE; 2.1.5 WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A, YES, NO -YES; 2.1.6 DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? N/A, YES, NO -NO; 2.1.7 PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. -COMMON BILE DUCT; 2.1.8 HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? -N/A; 2.1.9 FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17947801 ↗
• MalfunctionJun 20, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  CANCELLATION REPORT BEING SUBMITTED DUE TO THE LAB FINDINGS NO LONGER DEEMING THIS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161717 ↗
• InjuryJun 16, 2023Migration; Migration

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-JUL-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 17142392 ↗
• InjuryMay 24, 2023Complete Blockage; Adverse Event Without Identified Device or Use Problem; Complete Blockage; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTARY REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 12-JUL-2023.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16991781 ↗