Bard® Blakemore Esophageal-Nasogastric Tube 0092300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741076831), received between Jun 30, 2023 and Jan 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 17, 2025Class IOpen, Classified

   Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

   Z-1758-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PROCEDURE, THE ITEM WAS ALLEGEDLY FOUND TO HAVE A PERFORATION IN THE TUBING OF THE BLAKEMORE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167144 ↗
• MalfunctionJan 12, 2024Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE BALLOON HAD RUPTURED WHILE ON USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503756 ↗
• MalfunctionJun 30, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO (2) OF THE BLAKEMORE SPECIALTY TUBES DID NOT INFLATE PRIOR TO BEING INSERTED IN A PATIENT IN THE INTENSIVE CARE UNIT (ICU). IT WAS NOTED THAT THE SPECIALTY TUBES WERE NOT EXPIRED. THE CUSTOMER ADDITIONALLY NOTICED THAT THERE WAS DISCOLORATION WITH THE TWO (2) FAILED TUBES. EACH TUBE WAS A DIFFERENT LOT# AND EXPIRATION DATE. AS PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 12-JUNE-2023, THE CLINICAL EDUCATION SPECIALIST REPORTED THAT THE PATIENT WAS DECEASED. THE PATIENT WAS BEING CODED WHEN THE ENDOSCOPY TEAM ARRIVED TO SET UP THE TUBE, AND THE CODE WAS ANNOUNCED WHILE THE ENDOSCOPY TEAM WAS SETTING UP. THE TEAM HAD THE BLAKEMORE KIT SET UP, AND THEY ATTEMPTED TO TEST THE BALLOONS BEFORE USE. THE BALLOONS IN THE KIT WOULD NOT STAY INFLATED, ANOTHER KIT OBTAINED FROM THE ICU, BUT THE BALLOONS WOULD NOT STAY INFLATED. IT WAS ALSO NOTED THAT BOTH OF THESE FAILED DEVICES WERE DISCOLORED. AN ADDITIONAL TUBE WAS OBTAINED FROM THE OPERATING ROOM (OR). THERE WAS NO DISCOLORATION NOTED AND THE BALLOONS WERE ABLE TO REMAIN INFLATED. THE CLINICAL EDUCATION SPECIALIST STATED THAT THE ISSUES ENCOUNTERED WITH THE BLAKEMORE TUBES DID NOT DELAY NOR IMPACT THE OUTCOME. PE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237765 ↗