NAJA 9A-03110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506060985), received between Feb 11, 2026 and Sep 23, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• InjurySep 23, 2026Difficult to Advance; Positioning Problem

  Patient problems: Perforation

  MAUDE report 50874511 ↗
• InjuryFeb 11, 2026Use of Device Problem; Deformation Due to Compressive Stress; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A NAJA GASTROINTESTINAL BALLOON CATHETER WAS USED DURING AN ENDOSCOPIC ULTRASOUND GUIDED GASTROJEJUNOSTOMY (EUS-GJ) ON (B)(6) 2026. DURING REMOVAL OF NAJA BALLOON CATHETER, THE DISTAL BALLOON WOULD NOT DEFLATE. THE CATHETER WAS CUT WITH A WIRE CUTTER, AND THE PHYSICIAN LET THE AIR GRADUALLY COME OUT. ADDITIONALLY, THERE WAS A KINK IN THE CATHETER NEAR THE HUB. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316050 ↗