OverTube Endoscopic Access System OVT-027-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10811955020701), received between Jan 10, 2020 and May 28, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Material Integrity Problem

  NOTE: THIS RECORD REPRESENTS THE THIRD OF THREE OVERTUBE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERTUBE WAS USED IN AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF OBESITY. DURING THE PROCEDURE, THE INFLATION CUFFS ON THREE OVERTUBE DEVICES WOULD NOT INFLATE. THE PROCEDURE WAS CANCELLED DUE TO PATIENT'S DISTORTED ANATOMY. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325163 ↗
• MalfunctionMay 28, 2026Material Integrity Problem

  NOTE: THIS RECORD REPRESENTS THE FIRST OF THREE OVERTUBE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERTUBE WAS USED IN AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF OBESITY. DURING THE PROCEDURE, THE INFLATION CUFFS ON THREE OVERTUBE DEVICES WOULD NOT INFLATE. THE PROCEDURE WAS CANCELLED DUE TO PATIENT'S DISTORTED ANATOMY. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325161 ↗
• MalfunctionMay 28, 2026Material Integrity Problem

  NOTE: THIS RECORD REPRESENTS THE SECOND OF THREE OVERTUBE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERTUBE WAS USED IN AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF OBESITY. DURING THE PROCEDURE, THE INFLATION CUFFS ON THREE OVERTUBE DEVICES WOULD NOT INFLATE. THE PROCEDURE WAS CANCELLED DUE TO PATIENT'S DISTORTED ANATOMY. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325160 ↗
• MalfunctionMay 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON (B)(6) 2024 THAT THE OVERTUBE AND NXT SYSTEM WOULD NOT FIT TOGETHER. ON (B)(6) 2024 THE PHYSICIAN REPORT WHEN TRYING TO INTUBATE WITH THE SCOPE AFTER RE-TAPING THE DEVICE TO THE SCOPE AND ADDING ADDITIONAL LUBRICATION, THAT THE SCOPE AND NXT WOULD NOT FIT THROUGH THE OVERTUBE. THE PHYSICIAN TRIED MULTIPLE ATTEMPTS. THE PHYSICIAN REMOVED THE OVERTUBE AND THE PROCEDURE WAS COMPLETED WITH THE NXT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281823 ↗
• MalfunctionMay 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON APRIL 16, 2024 THAT THE OVERTUBE AND NXT SYSTEM WOULD NOT FIT TOGETHER. ON (B)(6) 2024 THE PHYSICIAN REPORT WHEN TRYING TO INTUBATE WITH THE SCOPE AFTER RE-TAPING THE DEVICE TO THE SCOPE AND ADDING ADDITIONAL LUBRICATION, THAT THE SCOPE AND NXT WOULD NOT FIT THROUGH THE OVERTUBE. THE PHYSICIAN TRIED MULTIPLE ATTEMPTS. THE PHYSICIAN REMOVED THE OVERTUBE AND THE PROCEDURE WAS COMPLETED WITH THE NXT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268093 ↗
• MalfunctionMar 22, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURING REPORT NUMBER 3005099803-2024-01049 FOR THE OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM AND 3005099803-2024-01220 FOR THE OVERTUBE ENDOSCOPIC ACCESS SYSTEM. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED IN A TRANSORAL OUTLET REDUCTION (TORE) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS SOME RESISTANCE WHEN MANEUVERING THE OVERSTITCH THROUGH THE OVERTUBE AND IT WAS NOTED THAT THE OVERTUBE WAS TORN. IT WAS REPORTED THAT THERE WAS LESS INFLATION THAN THEY WANTED. IN THE PHYSICIAN'S ASSESSMENT THE RESISTANCE AND MANEUVERING MAY HAVE CAUSED THE TEAR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THESE DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959055 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 31/MAR/2021 RECEIVED UF/IMPORTER REPORT # (B)(4). REPORTED: DURING THE INSERTION OF THE OR'S SCOPE INTO THE OVERTUBE DEVICE, AN ESOPHAGEAL PERFORATION WAS NOTED JUST DISTAL TO THE OVERTUBE. THE DEVICE WAS IMMEDIATELY REMOVED AND ENDOSCOPIC CLIPS WERE PLACED TO CLOSE THE PERFORATION.

  Patient problems: Perforation of Esophagus

  MAUDE report 11756200 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE REVIEW REPORTED: THERE WAS ONE CASE OF SUPERFICIAL ESOPHAGEAL TEAR FROM USING THE OVERTUBE WITH THE OVERSTITCH DEVICE WHICH WAS CONTROLLED ENDOSCOPICALLY WITHOUT NEED FOR REPEAT PROCEDURE.

  Patient problems: Perforation of Esophagus

  MAUDE report 10987184 ↗
• MalfunctionJan 10, 2020Crack; Inflation Problem; Device Slipped

  THE INSIDE OF THE TUBE WAS CRACKED, CAUSING THE DEVICE TO NOT INFLATE AND THEREFORE, COULD NOT HOLD TUBE IN PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9574572 ↗