Barrx 90-9200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521189379), received between Nov 15, 2016 and Nov 9, 2024 — classified as 1 death, 5 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, THE PATIENT HAD A LACERATION TO THE ESOPHAGUS FROM THE CATHETER. CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: Laceration(s) of Esophagus; Pain

  MAUDE report 20647107 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, THE OUTPUT CABLE WOULD NOT CONNECT TO THE OUTPUT CONNECTION ON TWO CATHETERS. PATIENT HAD A TEAR IN UPPER ESOPHAGUS WHEN TRYING TO REMOVE THE CATHETER. THREE CLIPS WERE PLACED ON TEAR TO ALLOW FOR HEALING. CUSTOMER PULLED A NEW CATHETER. PATIENT WAS ABLE TO LEAVE THE HOSPITAL THE SAME DAY AFTER CHEST X-RAY.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20351670 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, THE OUTPUT CABLE WOULD NOT CONNECT TO THE OUTPUT CONNECTION ON TWO CATHETERS. PATIENT HAD A TEAR IN UPPER ESOPHAGUS WHEN TRYING TO REMOVE THE CATHETER. THREE CLIPS WERE PLACED ON TEAR TO ALLOW FOR HEALING. CUSTOMER PULLED A NEW CATHETER. PATIENT WAS ABLE TO LEAVE THE HOSPITAL THE SAME DAY AFTER CHEST X-RAY.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20351612 ↗
• DeathJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PHYSICIAN USED AN ULTRA 90 CATHETER TO TREAT A 1 CM SEGMENT OF LOW DYSPLASIA. THE PATIENT WAS ON EFFIENT (BLOOD THINNER) BUT IT WAS HELD 7 DAYS PRIOR TO PROCEDURE. THE ABLATIONS WERE PERFORMED WITH 1 TAP ¿ CLEAN ¿ 1 TAP PROTOCOL GIVEN THEY USED THE ULTRA. THE PROCEDURE WAS VERY SHORT AND EXTREMELY UNEVENTFUL, NO SYMPTOMS AFTERWARDS. THERE WAS NOT EVEN ANY SIGNIFICANT OOZING AFTER RFA (RADIOFREQUENCY ABLATION) PERFORMED. THERE WAS NO EVIDENCE OF LIVER DISEASE, AND NO VARICES ON EXAM. THE PATIENT WAS DISCHARGED HOME ON THE TYPICAL REGIMEN OF SUCRALFATE, BID PPI (TWICE A DAY, PROTON PUMP INHIBITORS) AND VISCOUS LIDOCAINE AS PER OUR UNIT PROTOCOL FOLLOWING RFA. THE PATIENT WAS ASYMPTOMATIC UNTIL 10 DAYS AFTER THE RFA, WHEN THE PATIENT DEVELOPED ACUTE ONSET HEMATEMESIS (VOMITING OF BLOOD). THE PATIENT HAD TO RESUME EFFIENT AROUND A WEEK AFTER THE PROCEDURE DUE TO CARDIAC COMORBIDITIES. THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL FOR THE GASTROINTESTINAL BLEED AND INITIAL EGD SHOWED PRESENCE OF LARGE AMOUNT OF BLOOD IN THE ESOPHAGUS, BUT NOTHING ACTIVELY BLEEDING. THE PATIENT WAS EMBOLIZED BY IR (INTERVENTIONAL RADIOLOGY) AND FOLLOW UP EGD SHOWED ULCER

  Patient problems: Gastrointestinal Hemorrhage; Hematemesis; Unintended Radiation Exposure

  MAUDE report 12181065 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF THE STUDY PERFORMED BETWEEN JANUARY 2007 AND AUGUST 2017, 1 PATIENT DEVELOPED STRICTURES AND DILATIONS WASDONE 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 G ROUP 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 P ROTOCOL. 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 CARDIOVERSION. 1 PA

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

  MAUDE report 10020236 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS 18 J/CM2 DISPLAYED ON THE GENERATOR WHEN THE CATHETER WAS CONNECTED TO THE GENERATOR. THE PROCEDURE WAS THEN PERFORMED, BUT THE APPLICATION RESULTED TO ESOPHAGEAL ULCERATION FOLLOWED BY MANY WEEKS OF DIFFICULT PAIN.

  Patient problems: Pain; Ulceration

  MAUDE report 9338846 ↗
• InjuryNov 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT EXPERIENCED STRICTURE REQUIRING DILATION EIGHT WEEKS AFTER THE INITIAL PROCEDURE. THE PATIENT ALSO EXPERIENCED PAIN WHILE SWALLOWING. THIS WAS TREATED WITH ESOXX ONE AND PPI. AFTER THE PATIENT RECEIVED DILATION, HE WAS FEELING BETTER. PER THE ACCOUNT, THE DEVICE WORKED PROPERLY DURING THE PROCEDURE. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 6101837 ↗