Barrx 90-9100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521189362), received between Nov 15, 2018 and Jul 21, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2023Failure to Fire

  DURING THE CASE, THE DOCTOR WANTED TO DO AN ABLATION FOR BARRETT¿S ON THE PATIENT. THE MACHINE TURNED ON WITH NO PROBLEM. THE 90 RFA WAS PLACED ONTO THE SCOPE WITH NO ISSUES. WHEN THE DOCTOR WENT TO ABLATE THE ESOPHAGUS, THE 90 RFA WOULD NOT FIRE. THE 90 RFA WAS DISCONNECTED AND RECONNECTED A FEW TIMES, BUT IT DID NOT FIRE. THE SCOPE WAS TAKEN OUT OF THE PATIENT AND THE 90 RFA WAS REPLACED WITH ANOTHER 90 RFA. THE SCOPE WAS THEN INSERTED BACK IN THE ESOPHAGUS AND THE DOCTOR WAS ABLE TO ABLATE WITH NO ISSUES WITH THE NEW 90 RFA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370207 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WHO UNDERWENT RFA (RADIOFREQUENCY ABLATION) TREATMENT OF BARRETT'S ESOPHAGUS (ROUGHLY 7 CM) USED THE 90 FOCAL DEVICE. THE RFA PROCEDURE ITSELF WAS RELATIVELY UNREMARKABLE. THE PATIENT DEVELOPED STRICTURE, AND APPROXIMATELY 3 DILATION SESSIONS HAVE ALREADY BEEN ATTEMPTED. THE PATIENT HAD THE STRICTURE A FEW WEEKS AFTER THE CASE. THE PHYSICIAN USED A STENTFOR THE STRICTURE. THE PATIENT WAS NOW DOING WELL FROM THE STENT.

  Patient problems: Stenosis

  MAUDE report 12828471 ↗
• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLI 10: ACCORDING TO THE LITERATURE SOURCE OF THE STUDY PERFORMED BETWEEN JANUARY 2007 AND AUGUST 2017, 5 PATIENTS DEVELOPED STRICTURES AND DILATIONS WAS DONE AFTER THE RADIO FREQUENCY PROCEDURE. THE COMPARISON OF TWO RFA PROTOCOLS WHICH WAS 1 NON LABEL ( STANDARD) AND 1 OFF LABEL ( SIMPLIFIED) HAD MULTIPLE ADVERSE EVENT. 10 PATIENTS DEVELOPED ESOPHAGEAL STRICTURES FOLLOWING RFA (1 PATIENT IN STANDARD GROUP AND 9 PATIENTS IN SIMPLIFIED GROUP), WHICH WERE CLASSIFIED BY THE AUTHORS AS ¿COMPLICATIONS FROM RFA¿. STRICTURES WERE DILATED, WITH A MEDIAN OF 1 DILATION SESSION REQUIRED. 2 PATIENTS REQUIRED >2 DILATIONS (1 PATIENT REQUIRED 2 DILATIONS, 1 PATIENT REQUIRED 7 DILATIONS). THE SIMPLIFIED PROTOCOL WAS ASSOCIATED WITH 11 TIMES GREATER ODDS OF DEVELOPING STRICTURES COMPARED TO THE STANDARD PROTOCOL. TYPE OF RFA DEVICE WAS NOT ASSOCIATED WITH RISK OF STRICTURE. OF THE 12 PATIENTS THAT NEEDED RESCUE-EMR, 1 PATIENT DEVELOPED A STRICTURE. 2 PATIENTS TREATED WITH THE STANDARD PROTOCOL HAD SERIOUS ADVERSE EVENTS AS JUDGED BY THE AUTHORS. 1 PATIENT HAD SYMPTOMATIC ATRIAL FIBRILLATION WITHIN 36HR OF TWO ABLATION SESSIONS (1 CIRCUMFERENTIAL AND 1 FOCAL) AND NEEDED PHARMACOLOGICAL CARDIOVERSI

  Patient problems: Atrial Fibrillation; Chest Pain; Dysphagia/ Odynophagia; Laceration(s) of Esophagus

  MAUDE report 10017031 ↗
• MalfunctionSep 24, 2019Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING THE EGD (ESOPHAGOGASTRODUODENOSCOPY) OF THE BARRETT'S PROCEDURE, THE CABLE WOULD NOT CONNECT TO ANY OF THE CATHETERS. THE CUSTOMER OPENED 4 PACKAGES. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. THE PROCEDURE WAS ABORTED AND A REPEAT PROCEDURE WAS NECESSARY. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112608 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, PAIN AND DYSPHAGIA WAS EXPERIENCED BY 36 PATIENTS AT 3 WEEKS POST PROCEDURE. THE PAIN AND DYSPHAGIA THAT PERSISTED AFTER ADJUSTING FOR SIGNIFICANT VARIABLES INCLUDING INDICATION FOR ABLATION, TYPE OF PROCEDURAL SEDATION, AND WHETHER MEDICATION WAS PRESCRIBED FOR PAIN AFTER THE PROCEDURE WERE PROVIDED IN A SCALE.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 8401928 ↗
• InjuryNov 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, AFTER THE RADIO FREQUENCY ABLATION PROCEDURE OF BARRETT'S ESOPHAGUS, THE PATIENT PRESENTED TO THE PHYSICIAN FOR FURTHER REVIEW AS THE PATIENT WAS VERY UNWELL. THE PHYSICIAN PERFORMED A GASTROSCOPY AND FOUND A RUPTURED ESOPHAGUS. AN URGENT ESOPHAGECTOMY WAS PERFORMED AND THE PATIENT WAS CURRENTLY STILL IN THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN ENVISAGED THE PATIENT TO BE IN THE HOSPITAL FOR APPROXIMATELY THREE MONTHS. PATHOLOGY SHOWED THAT THE TREATMENT WAS NOT A FULL THICKNESS BURN AND RESULTED IN A PERMANENT INJURY. THERE WAS NO ERROR MESSAGE OR CODE DISPLAYED AND THERE WAS NO DEVICE DEFICIENCY NOTED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Rupture

  MAUDE report 8074630 ↗