Evolution G52226Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002522265), received between Jan 21, 2020 and Dec 5, 2022 — classified as 4 injuries, 1 malfunction.

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

• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: WAS THE STENT PLACED AT THE INTENDED LOCATION AT COMPLETION OF THE PROCEDURE? YES. WERE ANY ADDITIONAL PROCEDURE (S) PERFORMED DURING THE STUDY PROCEDURE? YES, DILATION. WERE ANY ADVERSE EVENTS DOCUMENTED DURING THE STENT PROCEDURE? NO. WERE ANY DEVICE DEFICIENCIES DOCUMENTED DURING THE PLACEMENT PROCEDURE? NO. ADVERSE EVENT: ESOPHAGUS PERFORATION. EVENT STATUS AT TIME OF STUDY EXIT: EVENT ONGOING. ADVERSE EVENT ONSET (DAYS POST STENT PLACEMENT): 75. EVENT TREATMENT: STUDY STENT REMOVED. VAC THERAPY BECAUSE OF ANASTOMSIS INSUFFICIENCY. WAS THE EVENT CONSIDERED TO BE RELATED TO THE STUDY DEVICE? RELATED. IF RELATED, PLEASE PROVIDE A DETAIL DESCRIPTION OF HOW STUDY DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT: PERFORATION OF THE ESOPHAGUS. WAS THE EVENT CONSIDERED TO BE RELATED TO THE STUDY PROCEDURE? RELATED. DID A PRE-EXISTING CONDITION, OR OTHER CONDITION OR CIRCUMSTANCE CAUSE OR CONTRIBUTE TO THIS EVENT? YES-PEC. AT THE CONCLUSION OF FOLLOW-UP WHAT WAS THE STATUS OF THE STUDY STENT: STENT REMOVED ENDOSCOPICALLY. DAYS POST STENT PLACEMENT: 86. REASON FOR REMOVAL: STENT NO LONGER NEEDED.

  Patient problems: Perforation

  MAUDE report 15915869 ↗
• InjuryDec 5, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  STENT #1: EVO-FC-20-25-10-E (C1440187). PROCEDURE: WERE ANY ADDITIONAL PROCEDURE (S) PERFORMED DURING THE STUDY PROCEDURE? YES DILATION. WERE ANY ADVERSE EVENTS DOCUMENTED DURING THE STENT PROCEDURE? NO. WERE ANY DEVICE DEFICIENCIES DOCUMENTED DURING THE PLACEMENT PROCEDURE? NO. 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. ADVERSE EVENT: STENT DISLOCATION + DYSPHAGIA ADVERSE EVENT ONSET (DAYS POST STENT PLACEMENT): 50 EVENT TREATMENT: STUDY STENT REPOSITIONED. WAS THE EVENT CONSIDERED TO BE RELATED TO. THE STUDY DEVICE? RELATED. IF RELATED, PLEASE PROVIDE A DETAIL DESCRIPTION OF HOW STUDY DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT: THERE WAS A DISLOCATION OF THE SECOND STENT. AFTER DILATATION TO 17MM THEY REPOSITIONED THE STENT AND DID A FIXATION WITH TWO RESOLUTION CLIPS. WAS THE EVENT CONSIDERED TO BE RELATED TO THE STUDY PROCEDURE? RELATED DID THE EVENT OCCUR DUE TO A DEVICE DEFICIENCY? YES-DISLOCATION OF THE STENT THIS FILE WILL CAPTURE USER ERROR

  Patient problems: Dysphagia/ Odynophagia; Obstruction/Occlusion

  MAUDE report 15914986 ↗
• MalfunctionFeb 17, 2020Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  REPORTED BY THE DM VIA PHONE CALL- THE PHYSICIAN STATED THE WIRE WOULD NOT DISENGAGE AND THE ONLY WAY TO GET THE WIRE OUT WAS TO PULL STENT OUT AS WELL. PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER STENT. NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED BY THE DM ON BEHALF OF THE CUSTOMER- IN SUMMARY. EVERYTHING WAS DONE PROPERLY. THE WIRE THAT IS SUPPOSED TO BE REMOVED AFTER THE STENT IS OUT AND NOT RECOVERABLE DID NOT COME OUT OF THE DEPLOYMENT SYSTEM. BECAUSE OF THIS, IT HAD TO BE REMOVED ALONG WITH THE DEPLOYMENT SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9716604 ↗
• InjuryFeb 3, 2020Off-Label Use; Activation, Positioning or Separation Problem; Off-Label Use; Activation, Positioning or Separation Problem

  COMPLAINT CALLED IN BY DM ON 06JAN2020--DID 07JAN2020. 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 KINKED INSI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Tears

  MAUDE report 9659973 ↗
• InjuryJan 21, 2020Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  ACCORDING TO THE INITIAL REPORTER: "WHILE PLACING ESOPHAGEAL STENT, THE WIRE WAS IN PLACE. WHEN THE PHYSICIAN WENT TO PLACE THE STENT OVER THE WIRE, THERE WAS VISIBLE RESISTANCE; (B)(6), 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. (B)(6) (COOK REPRESENTATIVE) TOLD PHYSICIAN TO HOLD, AND POSSIBLY CHANGE PATIENT POSITION, SINCE STENT WAS NOT VISIBLE UNDER FLUORO. (B)(6) 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 (ANOTHER MANUFACTURER). PHYSICIAN ASKED FOR ANOTHER WIRE. PHYSICIAN PULLED ORIGINAL WIRE OUT, PUT SCOPE DOWN PATIENT, AND THEY COULD SEE BLEEDING THAT WAS NOT NOTICED BY (B)(6) PRIOR TO THE RESISTANCE EVENT. (B)(6) MENTIONED NOT NOTICING ANY STRICTURING, PHYSICIAN ADVANCED THE NEW WIRE THROUGH THE SCOPE, (B)(6) 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 KINK

  Patient problems: Excessive Tear Production

  MAUDE report 9611387 ↗