EsoFLIP ES-330 (UDI 05391530810043)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05391530810043), received between Jun 15, 2017 and Sep 8, 2021 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K132337); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THERE WAS AN ESOPHAGEAL PERFORATION DURING THE PROCEDURE. THE CATHETER LOST PROCEDURE, THEY DEFLATED THEN INFLATED, BUT DID NOT REACH 20 MILLILITER, DEFLATED AGAIN, AND THEY NOTICED THE PERFORATION.

  Patient problems: Perforation of Esophagus

  MAUDE report 12440915 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE CATHETER PASSED PRE-USE CHECK. WHEN THEY TOOK THE CATHETER OUT AND WHEN BACK IN WITH THE SCOPE, THEY SAW A PERFORATION. THE PATIENT HAD A TORTUROUS ESOPHAGUS. THEY PUT A STENT IN TO HELP WITH DRAINAGE. THE PATIENT HAS AN EXISTING CONDITION OF ACHALASIA. THE PATIENT WAS DOING FINE.

  Patient problems: Pain; Perforation of Esophagus

  MAUDE report 11912110 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN ESOPHAGEAL TEAR DUE TO DILATION WHICH REQUIRED SURGERY. THE PATIENT WAS ADMITTED OVERNIGHT, SCOPED THE NEXT DAY THEN WAS SENT TO SURGERY. THEY NOTED NO SPECIFIC ISSUE ON THE CATHETER THAT CAUSED THE TEAR AND THE CATHETER WAS NOT DIFFICULT TO REMOVE FROM THE PATIENT.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 11723707 ↗
• MalfunctionApr 8, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE SCREEN OF THE SYSTEM FROZE AND THEY COULD NOT TELL IF THE CATHETER CONTINUED TO INFLATE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634354 ↗
• MalfunctionApr 8, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE SCREEN OF THE SYSTEM FROZE AND COULD NOT TELL IF THE CATHETER CONTINUED TO INFLATE. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634327 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD DYSPHAGIA AND WAS DIAGNOSED WITH (EJGOO)ESOPHAGOGASTRIC JUNCTION OUTFLOW OBSTRUCTION. DURING THE PROCEDURE THE ESOPHAGOGASTRIC JUNCTION WAS TIGHT AND IT WAS DILATED, BUT DISTENSIBILITY INDEX WAS STILL TIGHT, AND IT WAS DILATED AND SAW LARGE MUCOSAL TEAR. THE PATIENT DID WELL ON THE FIRST FEW HOURS POST PROCEDURE, AND THEN THE PATIENT HAD VIOLENT DRY HEAVES AND COUGHING, RESPIRATORY MEDICATION WAS PROVIDED, BUT COUGHING WAS NOT RESOLVED. X-RAY WAS PERFORMED TO CHECK FOR ASPIRATION AND THEN THE PATIENT HAD AN ACUTE EXCRUCIATING CHEST AND ABDOMINAL PAIN. X-RAY CONFIRMED PERFORATION AND IT ALSO SHOWED PNEUMOMEDIASTINUM. THE CUSTOMER PLACED AN ESOPHAGEAL STENT AND THE PATIENT DID WELL. THE PROCEDURE WAS COMPLETED WITH OUT ANY ISSUES UNIT THE PATIENT BEGAN COUGHING. SEVERAL DAYS POST PROCEDURE, THE PATIENT WAS STILL EXPERIENCING CHEST DISCOMFORT AND X-RAY SHOWED A SMALL AMOUNT OF WALLED OFF, CLOSED EXTRAVASATION. THE STENT WAS TAKEN OUT AS IT WAS CAUSING A LOT OF DISCOMFORT AND REFLUX, THE PATIENT STILL HAD SMALL WALLED OFF EXTRAVASATION AND REFLUX. THE PATIENT WAS HOSPITALIZED FOR 2 WEEKS AND 2 DAYS AND WAS PLACED ON LIQUID DIET PLUS (TPN) TOTA

  Patient problems: Abdominal Pain; Chest Pain; Excessive Tear Production; No Code Available; Perforation; Radiation Exposure, Unintended

  MAUDE report 8732971 ↗
• InjuryJun 15, 2017Insufficient Device Problem Information

  IT WAS REPORTED TO CROSPON THAT AN ESOFLIP ES-330 BALLOON DILATION CATHETER WAS USED IN A 30MM ACHALASIA DILATION PROCEDURES WHICH RESULTED IN ESOPHAGEAL PERFORATION. THE PERFORATION WAS NOT DETECTED DURING THE PROCEDURE, BUT BECAME EVIDENT DURING SUBSEQUENT TESTING WITH BARIUM. THE PERFORATION WAS TREATED WITH SURGERY, AND THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Perforation of Esophagus

  MAUDE report 6642842 ↗
• InjuryJun 15, 2017Patient-Device Incompatibility

  FOLLOW-UP REPORT SUBMITTED TO ADD USER FACILITY REPORT NUMBER.

  Patient problems: Perforation of Esophagus

  MAUDE report 6642796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132337. One submission often covers many models, so check the product and lot details in each record.

• Z-2038-2024 · Apr 25, 2024 · Open, Classified
  EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only