Evolution G48030Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10827002480305), received between Feb 22, 2016 and Apr 14, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Activation Failure; Physical Resistance/Sticking

  ECHEC DE POSE TO BE CONFIRMED. CUSTOMER DID NOT ANSWER THE EMAILS FROM SSC AND SBU.BUT THEY TOLD THE SBU THAT THIS DEVICE WAS USED IN DECEMBER 202526-MAR-26: PROBLEM FOR THE STAFF WHO WERE UNABLE TO REMOVE THE PIN (GOUPILLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875043 ↗
• MalfunctionDec 3, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 18-DEC-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703652 ↗
• InjuryMay 21, 2025Break; Migration; Break; Migration

  REPOSITIONING SUTURE CAME UNDONE OR BROKE. DR WANTED TO REPOSITION THE STENT AFTER PLACEMENT AS IT HAD SLIPPED AND HE USED STENT GRABBERS AND THE SUTURE BECAME DISCONNECTED FROM THE STENT. HE DECIDED TO REMOVE THE STENT WITH A SNARE WHICH WAS SUCCESSFUL AND PLACED A NEW STENT. THE SUTURE WAS NOT RETRIEVED. ARE IMAGES OF THE PROCEDURE AVAILABLE? NO PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. OESOPHAGUS WHAT INTERVENTION (IF ANY) WAS REQUIRED? STENT WAS SNARED TO REMOVE WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY SAME DAY A SECOND STENT PLACED.

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

  MAUDE report 22059972 ↗
• MalfunctionApr 15, 2025Component Misassembled; Separation Problem; Component Misassembled; Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-AUG-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21839728 ↗
• InjuryAug 9, 2023Adverse 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 30-NOV-2023.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17486562 ↗
• InjuryJul 28, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE REQUIREMENT (B)(4): STENT OBSTRUCTION AND SAFETY WIRE BREAKAGE RESULTING IN PAIN AND NAUSEA. ON (B)(6) 2022, A STENT WAS PLACED IN THE PATIENT'S ESOPHAGUS DUE TO DYSPHAGIA. ON (B)(6) 2022, A MONTH LATER, IT TURNED OUT THAT THE MUCOSA OF THE ESOPHAGUS WAS OVERGROWN WITH A STENT FROM BOTH ENDS. AND THE SAFETY WIRE IS BROKEN. IT BECAME IMPOSSIBLE TO REMOVE A STENT. PET-CT SHOWED THAT THE LUMEN OF THE STENT WAS OBSTRUCTED, SO ON (B)(6) 2022, THE STENT WAS LIFTED A LITTLE HIGHER BY GASTROSCOPY. THE PATIENT HAD PERSISTENT SEVERE PAIN AND NAUSEA AS A RESULT OF STENT PLACEMENT. (B)(4) USER ERROR - AFTER STENT PLACEMENT ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY SHOULD NOT BE ADMINISTERED. ON (B)(6) 2022, THE PATIENT BEGAN A WEEKLY COURSE OF CHEMOTHERAPY WITH PACLITAXEL AND CARBOPLATIN. IN ABOUT 10 DAYS AFTER THE START OF CHEMOTHERAPY, THE PRESSURE/PAIN AND NAUSEA WENT AWAY, BUT FOR THE LAST 10 DAYS THE PATIENT STARTED TO FEEL PAIN AND DIFFICULTY AT SWALLOWING, SO A CHEST CT WAS DONE, WHICH SHOWED THAT THE ONCOLOGICAL NODULES HAD SHRUNK AND PRESSURE ON THE ESOPHAGUS HAS BEEN LIFTED, ALTHOUGH IT TURNED OUT THAT THE MUCOSA OF THE ESOPHAGUS WAS OVERGROWN WITH A STENT FROM BOTH E

  Patient problems: Fever; Intraoperative Pain; Obstruction/Occlusion

  MAUDE report 15121165 ↗
• InjuryJul 28, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  (B)(6): STENT OBSTRUCTION AND SAFETY WIRE BREAKAGE RESULTING IN PAIN AND NAUSEA + USER ERROR: STENT REPOSITIONING. ON (B)(6) 2022, A STENT WAS PLACED IN THE PATIENT'S ESOPHAGUS DUE TO DYSPHAGIA. ON (B)(6) A MONTH LATER, IT TURNED OUT THAT THE MUCOSA OF THE ESOPHAGUS WAS OVERGROWN WITH A STENT FROM BOTH ENDS. AND THE SAFETY WIRE IS BROKEN. IT BECAME IMPOSSIBLE TO REMOVE A STENT. PET-CT SHOWED THAT THE LUMEN OF THE STENT WAS OBSTRUCTED, SO ON MAY 25, THE STENT WAS LIFTED A LITTLE HIGHER BY GASTROSCOPY. THE PATIENT HAD PERSISTENT SEVERE PAIN AND NAUSEA AS A RESULT OF STENT PLACEMENT. (B)(6): USER ERROR: PATIENT TREATED WITH CHEMOTHERAPY (AS PER IFU: AFTER STENT PLACEMENT ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY SHOULD NOT BE ADMINISTERED). ON JUNE 2, 2022, THE PATIENT BEGAN A WEEKLY COURSE OF CHEMOTHERAPY WITH PACLITAXEL AND CARBOPLATIN. IN ABOUT 10 DAYS AFTER THE START OF CHEMOTHERAPY, THE PRESSURE/PAIN AND NAUSEA WENT AWAY, BUT FOR THE LAST 10 DAYS THE PATIENT STARTED TO FEEL PAIN AND DIFFICULTY AT SWALLOWING, SO A CHEST CT WAS DONE, WHICH SHOWED THAT THE ONCOLOGICAL NODULES HAD SHRUNK AND PRESSURE ON THE ESOPHAGUS HAS BEEN LIFTED, ALTHOUGH IT TURNED OUT THAT THE MUCOSA

  Patient problems: Nausea; Obstruction/Occlusion; Pain

  MAUDE report 15121139 ↗
• InjuryJul 28, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PR (B)(4): STENT OBSTRUCTION AND SAFETY WIRE BREAKAGE RESULTING IN PAIN AND NAUSEA. ON (B)(6) 2022, A STENT WAS PLACED IN THE PATIENT'S ESOPHAGUS DUE TO DYSPHAGIA ON (B)(6) A MONTH LATER, IT TURNED OUT THAT THE MUCOSA OF THE ESOPHAGUS WAS OVERGROWN WITH A STENT FROM BOTH ENDS. AND THE SAFETY WIRE IS BROKEN. IT BECAME IMPOSSIBLE TO REMOVE A STENT. PET-CT SHOWED THAT THE LUMEN OF THE STENT WAS OBSTRUCTED, SO ON (B)(6) THE STENT WAS LIFTED A LITTLE HIGHER BY GASTROSCOPY. THE PATIENT HAD PERSISTENT SEVERE PAIN AND NAUSEA AS A RESULT OF STENT PLACEMENT. PR (B)(4): USER ERROR - AFTER STENT PLACEMENT ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY SHOULD NOT BE ADMINISTERED. ON (B)(6) 2022, THE PATIENT BEGAN A WEEKLY COURSE OF CHEMOTHERAPY WITH PACLITAXEL AND CARBOPLATIN. IN ABOUT 10 DAYS AFTER THE START OF CHEMOTHERAPY, THE PRESSURE/PAIN AND NAUSEA WENT AWAY, BUT FOR THE LAST 10 DAYS THE PATIENT STARTED TO FEEL PAIN AND DIFFICULTY AT SWALLOWING, SO A CHEST CT WAS DONE, WHICH SHOWED THAT THE ONCOLOGICAL NODULES HAD SHRUNK AND PRESSURE ON THE ESOPHAGUS HAS BEEN LIFTED, ALTHOUGH IT TURNED OUT THAT THE MUCOSA OF THE ESOPHAGUS WAS OVERGROWN WITH A STENT FROM BOTH ENDS. PR (B)(4): USER E

  Patient problems: Nausea; Pain

  MAUDE report 15121138 ↗
• MalfunctionOct 28, 2021Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO DEVICE EVALUATION ON 09-DEC-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712436 ↗
• InjuryJul 13, 2020Positioning Failure; Deformation Due to Compressive Stress; Positioning Failure; Deformation Due to Compressive Stress

  THE INVESTIGATION WAS CONCLUDED ON THE 09-OCT-2020, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS WITHIN SECTION H10.

  Patient problems: Failure of Implant; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10268205 ↗
• MalfunctionJul 10, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE STENT WAS EXPOSED DURING PROCEDURE AND THE APPLICATOR TO REMAIN IN PATIENT WAS PULLED OUT AS WELL. PRODUCT WONT BE RETURNED. CUSTOMER DISPOSED. HIGHLY CONTAMINATED. "AS PER COMPLAINT FORM": THE STENT WAS RELEASED BUT WAS WITH THE INTRODUCTION SYSTEM WITHDRAWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8775785 ↗
• InjuryJan 3, 2019Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  THE DEVICE HAD AN ISSUE WITH THE RELEASE SYSTEM. THUS THE PRODUCT COULD NOT BE IMPLANTED PROPERLY. EVERYTHING HAS BEEN REMOVED AND STERILIZED. "AS PER COMPLAINT FORM": DURING THE RELEASE OF THE PROSTHESIS THE SAME WAS MOVED PROXIMALLY, NOT OPENING THE DISTAL BELL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. REMOVAL OF THE STENT WITH A FOREIGN BODY FORCEPS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NOTHING. PUT OTHER STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211992 ↗
• InjurySep 27, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ESOPHAGUS STENT PLACEMENT WAS PERFORMED TO THE PATIENT WHO HAD CARDIAC PORTION OF THE ESOPHAGUS STENOSIS DUE TO STOMACH CANCER INVASION. AFTER STENT PLACEMENT, THE USER ATTEMPTED TO WITHDRAW THE DELIVERY SYSTEM FROM THE PATIENT'S BODY, HOWEVER THE TIP OF THE DELIVERY SYSTEM GOT STUCK AT DISTAL SIDE OF THE STENT, THEN, THE STENT MIGRATED AND PLACED MORE PROXIMAL SIDE WHERE HAS NOT BEEN COVERED STENOSED LESION. TO RETRIEVE THE STENT, ENDOSCOPY WAS INSERTED AND LASSO WAS GRABBED WITH SNARE. AFTER WITHDRAW THE STENT INTO ENDOSCOPY, STENT AND ENDOSCOPY WERE REMOVED TOGETHER. ANOTHER STENT OF THE SAME RPN WAS PLACED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7913807 ↗
• InjuryJul 4, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  REPORT IS BEING SUBMITTED UNDER REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM' . COMPLAINT: FINISHED DEPLOYING STENT, SAFETY WIRE WAS REMOVED. END OF STENT WAS STUCK IN INTRODUCER IT WOULD NOT FULLY DEPLOY. DR WAITED 10 MINS AND TRIED AGAIN BUT STENT STILL WOULD NOT DETACH FROM INTRODUCER. DR ENDED UP REMOVING THE INTRODUCER WITH STENT & HAD TO START PROCEDURE AGAIN WITH ANOTHER DEVICE. "AS PER COMPLAINT FORM: END OF STENT WAS STUCK IN INTRODUCER IT WOULD NOT FULLY DEPLOY DESPITE SAFETY WIRE BEING RELEASED.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7662430 ↗
• MalfunctionJun 12, 2018Kinked; Activation, Positioning or Separation Problem; Kinked; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER PUT DEVICE INTO THE PATIENT OVER A SAVARY WIRE AND THE DEVICE WOULD NOT DEPLOY. DEVICE PUMPED, BUT WOULDN'T DEPLOY OUT OF DELIVERY SYSTEM. IT WAS IN GEAR. CUSTOMER HEARD A POP SOUND, TOOK DEVICE OUT AND USED A NEW ONE SUCCESSFULLY." DM UNSURE REGARDING EVENT DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7591701 ↗
• MalfunctionFeb 22, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DR (B)(6) AND DR (B)(6) ENCOUNTERED DIFFICULTIES WITH THE SAFETY WIRE REMOVAL WHEN TRYING TO DEPLOY THE EVOLUTION STENT. THEY COULD NOT FULLY DEPLOY THE STENT. INCIDENT MEETS REPORTING CRITERIA BASED ON THE MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY FOR A DEPLOYMENT ISSUE RESULTING IN THE EXPOSED STENT BEING REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM. THE STENT POINT OF NO RETURN HAS BEEN PASSED WHEN THE USER IS INSTRUCTED TO REMOVE THE SAFETY WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5450444 ↗