OBALON® 7410-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859810006234), received between Mar 11, 2020 and Apr 9, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN EARLY ENDOSCOPIC REMOVAL ON (B)(6) 2020, AN UNINFLATED BALLOON AND SEVERE ESOPHAGITIS WITH NO BLEEDING WERE FOUND IN THE LOWER THIRD OF THE ESOPHAGUS. THERE WAS CIRCUMFERENTIAL ULCERATION AND THE BALLOON WAS SUCCESSFULLY REMOVED BY ENDOSCOPY. THE REMOVED BALLOON WAS DISCARDED AND NOT RETURNED TO OBALON FOR INVESTIGATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ONGOING CARE AND DISCHARGED THE NEXT DAY. THE PATIENT HAD THIS FIRST AND ONLY BALLOON ADMINISTERED ON (B)(6) 2020 USING THE NAVIGATION AND TOUCH DISPENSER SYSTEM AND REPORTED SYMPTOMS OF HICCUPS AND DYSPEPSIA TO THE PRESCRIBING PHYSICIAN AFTER THE BALLOON ADMINISTRATION. THE TOUCH DISPENSER USED DURING THE ADMINISTRATION AND NAVIGATION RECORDING OF THE ADMINISTRATION WERE PROVIDED TO OBALON FOR INVESTIGATION. THE ADMINISTRATION RECORD FROM THE SITE DOCUMENTED THE FINAL BALLOON PRESSURE WELL BELOW THE LABELED FINAL BALLOON PRESSURE PER THE INSTRUCTIONS FOR USE. DURING THE INVESTIGATION, THE TOUCH DISPENSER WAS RETURNED FOR EVALUATION AND THE USE CASE DATA WAS DOWNLOADED. THE RECORDED DATA SHOWED THAT ESOPHAGEAL PRESSURE CHECK HIGH ERROR WAS DISPLAYED FOUR TIMES AND THEN THE CASE WAS ENDED. EVACUATION WITH THE 60

  Patient problems: Hiccups

  MAUDE report 9947486 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH ONE BALLOON ADMINISTERED ON (B)(6) 2020 HAD THE BALLOON REMOVED LESS THAN TWO WEEKS AFTER ADMINISTRATION DUE TO GASTRIC OUTLET OBSTRUCTION. THE PATIENT BEGAN EXPERIENCING SYMPTOMS OF ABDOMINAL PAIN, NAUSEA, AND VOMITING AND PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2020 AND A CT SCAN SHOWED A GASTRIC OUTLET OBSTRUCTION. THE INFLATED BALLOON IN THE STOMACH WAS REMOVED ENDOSCOPICALLY ON (B)(6) 2020. THE PATIENT WAS HOSPITALIZED ONE DAY AND WAS STABLE AFTER DISCHARGE. THE BALLOON WAS RETURNED TO OBALON FOR INVESTIGATION.

  Patient problems: Abdominal Pain; Nausea; Vomiting

  MAUDE report 9821774 ↗