Ultraflex™ Esophageal NG M00513800Recalls & reported problems
Boston Scientific Corporation · Proximal Release Stent System · Class 2 · Implant
All models of Ultraflex Esophageal NG (15)
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 08714729716174), received between Jan 28, 2020 and Jan 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2020Activation Failure; Activation Failure
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 06, 2020 THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE UNCOVERED STENT WAS IMPLANTED IN THE OESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, IT WAS FELT THAT THE STENT DID NOT STAY FULLY OPEN. THE PATIENT WAS RE-SCOPED AND IT WAS CONFIRMED THAT THE STENT FAILED TO EXPAND AND WAS NOT FULLY OPEN. THE PHYSICIAN TRIED TO EXPAND THE STENT USING A DILATATION BALLOON CATHETER AND THEN IT OPENED WITH THE USE OF RAT TOOTH FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.
Patient problems: No Code Available
MAUDE report 9639729 ↗
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.
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