EndoMAXX® 00884450147627Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450147627), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE STENT WAS INITIALLY PLACED (B)(6) 2019. PATIENT DID NOT ATTEND ANY FOLLOW UPS AFTER PLACEMENT DUE TO ALLEGED INCARCERATION. PATIENT WAS SEEN IN (B)(6) 2020 FOR POSSIBLE STENT REMOVAL AS THE STENT HAD MIGRATED TO THE STOMACH. THERE IS NO KNOWLEDGE OF WHEN THE STENT MIGRATED. DR. GOODMAN WENT INTO RETRIEVE THE STENT PULLING THE PROXIMAL LOOP AND IT HAD BROKEN OFF AS HE WAS PULLING IT THROUGH THE LES. THE PHYSICIAN STATED THAT HE WAS ABLE TO TAKE OUT ABOUT AN INCH OF THE STENT. AT THIS POINT THE MSL WAS CONFERENCED IN TO ASSIST. THE REMAINDER OF THE STENT HAD TO BE PIECE-MEALED THROUGH AN OVER-TUBE UNTIL HE WAS FINALLY ABLE TO GRAB THE DISTAL LOOP SUTURE AND PULL OUT THE REST OF THE STENT INTO THE OVER-TUBE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10456610 ↗
Other PROSTHESIS, ESOPHAGEAL devices
- WallFlex™ Esophageal M00516730Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall29 reports
- WallFlex™ Esophageal M00516740Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death22 reports
- WallFlex™ Esophageal M00516750Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death19 reports
- WallFlex™ Esophageal M00516700Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall18 reports
- WallFlex™ Esophageal M00516910Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall15 reports
- WallFlex™ Esophageal M00516930Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall14 reports
- WallFlex™ Esophageal M00516710Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall13 reports
- WallFlex™ Esophageal M00516940Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page