Evolution G52227Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002522272), received between Mar 14, 2016 and Sep 21, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50846472 ↗
• MalfunctionJun 28, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  DESCRIPTION OF EVENT: THE TRIGGER WAS JAMMED & HENCE THE STENT COULD NOT BE DEPLOYED. PATIENT/EVENT INFO - NOTES: NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631394 ↗
• MalfunctionDec 5, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT (B)(4) STENT #2 - USER ERROR: PATIENT RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT. STENT #2: (B)(4) (B)(6) PROCEDURE: WERE ANY ADDITIONAL PROCEDURE (S) PERFORMED DURING THE STUDY PROCEDURE? NO. WERE ANY ADVERSE EVENTS DOCUMENTED DURING THE STENT PROCEDURE? YES. WERE ANY DEVICE DEFICIENCIES DOCUMENTED DURING THE PLACEMENT PROCEDURE? YES. WAS TUMOR-REDUCTION THERAPY DOCUMENTED DURING FOLLOW UP? CHEMOTHERAPY. USER ERROR: AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING. PATIENT OUTCOME: AT THE CONCLUSION OF FOLLOW-UP WHAT WAS THE STATUS OF THE STUDY STENT: STENT REMOVED ENDOSCOPICALLY. DAYS POST STENT PLACEMENT: 199. REASON FOR REMOVAL: OTHER (UNRELATED TO AE) NEW STENOSIS BECAUSE OF HYPERPLASTIC TUMOR TISSUE. PRIMARY REASON FOR STUDY EXIT : DEATH. CAUSE OF DEATH: TUMOR PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915312 ↗
• MalfunctionSep 20, 2022Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  CANCELLATION REPORT BEING SUBMITTED.THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016) ADDITIONAL INFORMATION RECEIVED ON 08-NOV-2022 - INCORRECT SIZE WIRE GUIDE USED. LAB EVALUATION ON (B)(6) 2022 VISUAL INSPECTION RED MARKER AT FIRST DIMPLE. PIGTAIL SAFETY WIRE STILL IN PLACE. FUNCTIONAL INSPECTION: HANDLE ACTUATING FINE FOR DEPLOYMENT AND RECAPTURE. STENT DEPLOYED WITH NO ISSUE. SAFETY WIRE REMOVED WITH NO ISSUE. STENT RELEASED AND INTACT. AS REPORTED TO CUSTOMER RELATIONS VIA EMAIL "WHEN DEPLOYING THE STENT, THE STENT WOULD NOT STAY IN PLACE." 1.DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? · IF YES, PLEASE DESCRIBE. NO 2.WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO 3.DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? · IF YES, PLEASE DESCRIBE. NO 4.DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? · IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. NO 5.HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE T

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455496 ↗
• InjuryApr 23, 2020Off-Label Use; Off-Label Use

  COMPLAINT CALLED IN BY DM ON (B)(6) 2020--DID (B)(6) 2020. AS REPORTED TO CUSTOMER RELATIONS: "WHILE PLACING ESOPHAGEAL STENT, THE WIRE WAS IN PLACE. WHEN THE PHYSICIAN WENT TO PLACE THE STENT OVER THE WIRE, THERE WAS VISIBLE RESISTANCE; DM, WATCHING UNDER FLUORO, SAW THAT STENT WAS NOT MOVING DOWN/ADVANCING OVER THE WIRE. PHYSICIAN WAS HAVING DIFFICULTY PUSHING STENT OVER WIRE IN THE PATIENT'S MOUTH. DM TOLD PHYSICIAN TO HOLD, AND POSSIBLY CHANGE PATIENT POSITION, SINCE STENT WAS NOT VISIBLE UNDER FLUORO. DM HAD THEM STOP AND PULL IT BACK OUT OF PATIENT'S MOUTH; PHYSICIAN DETERMINED THAT THE WIRE WAS THE ISSUE AT THIS POINT. PHYSICIAN PULLED STENT OUT, OFF OF THE WIRE, AND ALL COULD SEE THAT WIRE WAS BENT IN 3 PLACES ((B)(4)). PHYSICIAN ASKED FOR ANOTHER WIRE. PHYSICIAN PULLED ORIGINAL WIRE OUT, PUT SCOPE DOWN PATIENT, AND THEY COULD SEE BLEEDING THAT WAS NOT NOTICED BY DM PRIOR TO THE RESISTANCE EVENT. DM MENTIONED NOT NOTICING ANY STRICTURING, PHYSICIAN ADVANCED THE NEW WIRE THROUGH THE SCOPE, DM ASKED IF THEY COULD DO A COUPLE TRIGGER PULLS THEMSELVES, TO SIMULATE RECAPTURING TO MAKE SURE IT WORKED OKAY--IT DID DEPLOY AND RECAPTURE SMOOTHLY. HOWEVER, THE STENT WAS VISIBLY KINKE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Known Impact Or Consequence To Patient

  MAUDE report 9990931 ↗
• MalfunctionMar 14, 2016Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT. EVENT DESCRIPTION SUBMITTED AS FOLLOWS: AN EVOLUTION ESOPHAGAL STENT WAS USED ON A PATIENT WITH A STRICTURE - MIDWAY THROUGH THE PROCEDURE THE HCP NOTICED THE WHITE PLASTIC TIP ATTACHED TO THE END OF THE SYSTEM HAD FALLEN OFF AND DISAPPEARED INTO THE STOMACH. THE WHOLE DEVICE WAS REMOVED AS THE HCP WAS CONCERNED THE MECHANISM WOULD NOT WORK AND DELIVER THE STENT INTO THE APPROPRIATE POSITION. EVENT MEETS REPORTING CRITERIA BASED ON THE MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY FOR THE FAILURE 'TIP SEPARATION'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5496926 ↗