BIG60™ TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450860373), received between Aug 14, 2026 and Aug 14, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “No Device Output” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026No Device Output; No Pressure

  Customer reported that the pressure monitoring gauge did not register any pressure reading during balloon inflation. Subsequently, the patient sustained an esophageal perforation, described as a moderate focal full-thickness tear measuring approximately 2 cm in diameter at approximately 22 cm from the incisors. Following the perforation, the patient developed a pneumothorax and required chest tube placement for management.

  Patient problems: Perforation of Esophagus; Pneumothorax

  MAUDE report 50256388 ↗