Evolution G48025Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002480251), received between Jul 18, 2017 and Dec 10, 2025 — classified as 4 injuries, 10 malfunctions.

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

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Break; Activation Failure; Break; Activation Failure

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 26-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767057 ↗
• MalfunctionJul 5, 2021Retraction Problem; Premature Separation; Retraction Problem; Premature Separation

  THE STENT OPENED AND WOULDN'T CLOSE BACK EVEN THOUGH THE RELEASE SYSTEM HAD NOT REACHED THE "NON RETURN" MARK "AS PER CC FORM": DURING STENT RELEASE, WHEN THE STENT WAS PARTIALLY OPENED BUT SMALL ADJUSTMENTS IN THE ENDOSCOPE POSITION WERE MADE TO OBTAIN A BETTER ENDOSCOPIC VIEW, ALTHOUGH THE "POINT-OF-NO-RETURN" HAD NOT BEEN REACHED NEITHER IN THE SHOOTING "GUN" NOR RADIOLOGICALLY, THE STENT RELEASED COMPLETELY. ATTEMPT TO RECLOSE THE STENT WERE FUTILE, RESULTING IN STENT FOLDING. THE STENT WAS THEREFORE REMOVED. ADDITIONAL INFO RECEIVED 18-JUN-21: "IT WAS REMOVED PARTIALLY DEPLOYED"." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A NEW STENT WAS PLACED ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE QUESTIONS IN ADDITION: - WAS THE STENT REMOVED FROM THE PATIENT PARTIALLY DEPLOYED? OR IS THE DEVICE PLACED IN AN UNINTENDED LOCATION IN THE PATIENT? IT WAS REMOVED PARTIALLY DEPLOYED - WERE ANY KINKS/BREAKS NOTED ON THE DELIVERY SYSTEM AFTER THIS INCIDENT OCCURRED? NO . AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116387 ↗
• MalfunctionApr 28, 2021Break; Activation Failure; Break; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737552 ↗
• InjuryOct 8, 2020Partial Blockage; Fracture; Off-Label Use; Partial Blockage; Fracture; Off-Label Use

  SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED DUE TO AMENDMENT TO THE LOT NUMBER DOCUMENTED WITHIN SECTION D4 OF PREVIOUSLY SUBMITTED REPORT.

  Patient problems: Obstruction/Occlusion; Occlusion

  MAUDE report 10651177 ↗
• InjurySep 1, 2020Fracture; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Fracture; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  IMPLANT DATE UPDATED (B)(6) 2020.

  Patient problems: No Known Impact Or Consequence To Patient; Obstruction/Occlusion

  MAUDE report 10480015 ↗
• InjuryJun 17, 2020Break; Fracture; Improper or Incorrect Procedure or Method; Break; Fracture; Improper or Incorrect Procedure or Method

  THIS FOLLOW UP IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION. "AS PER COMPLAINT FORM": STENT IMPLANTED THE (B)(6) 2019 WITHOUT PROBLEM. PATIENT CAME BACK TO HOSPITAL ON (B)(6) 20 WITH DIGESTIVE BLEEDING. PATIENT ADMITTED IN REANIMATION SERVICE AND TREATED WITH CLIP AND HEMOSPRAY. BLEEDING CAUSED BY CROWN OF DUODENAL STENT BROKEN. DOCTOR PREFERRED KEEPING STENT IN PLACE TO AVOID STRONGER BLEEDING. NO MORE INFO FROM PATIENT. PATIENT COME BACK TO HOSPITAL 9 MONTHS LATER ((B)(6) 2020) WITH DIGESTIVE BLEEDING. PATIENT ADMITTED IN REANIMATION SERVICE AND TREATED WITH CLIP AND HEMOSPRAY (HEMOSPRAY BECAUSE CUSTOMER DOESN¿T WANT RETURN HIS STOCK) BLEEDING CAUSED BY CROWN OF DUODENAL STENT BROKEN. DR PREFERRED KEEPING STENT IN PLACE TO AVOID STRONGER BLEEDING. NO MORE INFORMATION FROM PATIENT. COPIED FROM ATTACHED MAIL - '1ST REQUEST (B)(4) COMPLAINTS (B)(4) PRODUCT COMPLAINT FROM BICETRE HOSPITAL' THE OTHER CONCERNS A DUODENAL PROSTHESIS REF EVO-22-27-6D LOT C1633329, IMPLANTED WITHOUT PROBLEM ON (B)(6) 2019, IN A PATIENT SUFFERING FROM A TUMOR OF THE TAIL OF THE PANCREAS WITH RETRO-GASTRIC PERITONEAL CARCINOSIS. THE PATIENT HAD TO BE ADMITTED URGENTLY ON BICÊTRE FOR A DIGES

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10165185 ↗
• MalfunctionDec 10, 2019Difficult to Advance; Difficult to Advance

  THIS REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED BASED ON THE RECEIPT OF ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9443471 ↗
• InjuryJan 10, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING DEPLOYMENT, THE YELLOW MARKER WAS IN VIEW AND UPON 50% DEPLOYMENT, THE USER PULLED THE SAFETY WIRE BUT IT WAS EXTREMELY DIFFICULTY TO REMOVE. THE WIRE WAS REMOVED WITH FORCE, AND THE STENT DEPLOYED SIGNIFICANTLY PAST THE INTENDED TARGET SITE. ANOTHER STENT IS SCHEDULED TO BE PLACED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8235795 ↗
• MalfunctionApr 25, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. THE PHYSICIAN ATTEMPTED TO PLACE THE STENT TO TREAT THE STRICTURE OF THE HORIZONTAL PART OF DUODENUM, BUT A DISTAL SIDE OF THE STENT WAS NOT FULLY EXPAND DURING DEPLOYMENT. THEREFORE, HE RETRACTED THE STENT INTO THE SHEATH FOR THE SECOND TRY. HOWEVER BECAUSE THE SAME THING OCCURRED ALSO AT THE SECOND ATTEMPT OF DEPLOYMENT, ANOTHER EVO- (9CM) WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457322 ↗
• MalfunctionMar 30, 2018Fracture; Fracture

  STENT DISSOLVED/ BROKE APART. "AS PER COMPLAINT FORM": FIRST STENT 6 CM PLACED AT THE (B)(6) 2017. PROLONGATION WITH SECOND STENT 9 CM ON THE (B)(6) 2017. CONTROL (B)(6). SECOND CONTROL (B)(6). THIRD CONTROL (B)(6). EVERYTHING IS OKAY. FOURTH CONTROL (B)(6) 2018: STENT DISSOLVED. CUSTOMERS STATES THAT THE PATIENT SURVIVED LONG THEN EXPECTED PATIENT IS PRE-TERMINAL NOW SO NO FURTHER PROCEDURES PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384982 ↗
• MalfunctionDec 29, 2017Delivery System Failure; Delivery System Failure

  FOLLOW UP MDR SUBMITTED TO UPDATE INVESTIGATION DETAILS MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED". A PATIENT WHO HAD DUODENAL BULB STRICTURE UNDERWENT DEODENAL STENT PLACEMENT. THE ENDOSCOPE (OLYMPUS/GIF-2T240) WAS INSERTED, AND THE WIRE GUIDE (0.035 INCH) WAS PLACED. THEN, DELIVERY SYSTEM WAS INSERTED INTO THE DESIRED LESION. THE PHYSICIAN HELD THE ENDOSCOPE AND THE NURSE HELD THE DELIVERY SYSTEM AND ATTEMPTED TO DEPLOY THE STENT. WHEN THE NURSE ATTEMPTED TO DEPLOY THE STENT BY SQUEEZING THE HANDLE, THE STENT DID NOT START DEPLOYMENT. THEN, THE SHEATH GOT SEPARATED FROM THE HANDLE THEREFORE THE STENT WOULD NOT BE DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS REPLACED WITH ANOTHER DEVICE (9CM) TO COMPLETE THE PROCEDURE WITHOUT PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153787 ↗
• MalfunctionOct 6, 2017Delivery System Failure; Delivery System Failure

  FOLLOW UP MDR SUBMITTED DUE TO: DEVICE RETURN. THE DEPLOYMENT HANDLE BROKE DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6921420 ↗
• MalfunctionAug 17, 2017Delivery System Failure; Activation, Positioning or Separation Problem; Delivery System Failure; Activation, Positioning or Separation Problem

  THE USER ADVANCED DEVICE ALONG WIRE GUIDE UNDER ENDOSCOPE TO DESIRED POSITION. SQUEEZE THE TRIGGER UNTIL THE RED MARKER ON TOP OF INTRODUCER HAD PASSED THE POINT-OF-NO-RETURN INDICATOR ON HANDLE. BUT THE STENT STILL DIDN'T DEPLOY. WITHDRAW THE DEVICE AND REPLACE THE SAME MODULE STENT TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799831 ↗
• MalfunctionJul 18, 2017Delivery System Failure; Delivery System Failure

  THIS REPORT IS BEING SUBMITTED DUE CORRECTIONS THE STENT DID NOT EXPAND DURING THE MANIPULATION. STENT RELEASE PROCESS WAS FAILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6721125 ↗