Barrx 1190A-115ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521177796), received between Apr 26, 2018 and Jul 29, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K092487); 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ONSET OF ATRIAL FIBRILLATION FOLLOWING THE RADIOFREQUENCY ABLATION PROCEDURE.

  Patient problems: Atrial Fibrillation

  MAUDE report 22641106 ↗
• MalfunctionNov 14, 2019Calibration Problem; Power Problem; Calibration Problem; Power Problem

  ACCORDING TO THE REPORTER, DURING A RADIO FREQUENCY ABLATION OF BARRETT¿S ESOPHAGUS, DURING THE SECOND PASS, THE GENERATOR FAILED TO WORK. THE UNIT FAILED TO START BALLOON INFLATION DESPITE SECURE CONNECTION BETWEEN THE CATHETER AND OUTPUT CABLE. THERE WAS NO ERROR MESSAGE DISPLAYED ON THE GENERATOR¿S SCREEN. ATTEMPTS USING THE RESET BUTTON, PLUS TURNING ON/OFF THE GENERATOR MULTIPLE TIMES BUT IT DID NOT WORK. THEY NOTICED THAT UPON RESTARTING THE GENERATOR, THE UNIT FAILED TO PASS SELF-CHECK AND AS A RESULT THE PROCEDURE WAS ENDED. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. THERE WAS NO PATIENT AND USER INJURY. A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323659 ↗
• MalfunctionJul 10, 2019Power Problem; Power Problem

  ACCORDING TO THE REPORTER, DURING EGD (ESOPHAGOGASTRODUODENOSCOPY), THE OUTPUT CABLE FAILED. THE DEVICE WORKED ALL DAY BUT WOULD NOT WORK ON THIS PATIENT. IT WAS INABILITY TO CONDUCT ENERGY TO ALLOW FOR THE RFA (RADIOFREQUENCY ABLATION) TO BE COMPLETED. THEY ATTEMPTED TO USE A DIFFERENT DISPOSABLE CATHETER WITH THE SAME ISSUE. NO RFA WAS ABLE TO BE COMPLETED. THE PHYSICIAN DID AN EGD ONLY. THE GENERATOR SCREEN SHOWED NORMAL AND ALL CONNECTIONS WERE CHECKED WITH NO LOOSE COMPONENTS. THERE WAS NO PATIENT AND USER HARM. THE PATIENT WAS RESCHEDULED AT A LATER DATE FOR A REPEAT RFA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776803 ↗
• MalfunctionJul 5, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING ESOPHAGOGASTRODUODENOSCOPY, THE GENERATOR WAS ATTEMPTED WITH 2 DIFFERENT PROBES BUT COULD NOT HOLD INSUFFLATION. THEY USED AN ULTRA-LONG FOCAL CATHETER AND THEY WERE ABLE TO ACHIEVE 35 ABLATIONS AND THEN THE PROCEDURE WAS ABORTED. THE GENERATOR DISPLAYED AN ERROR CODE E95 - AIR LEAK. THERE WAS NO PATIENT AND USER HARM, AND NO MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. A REPEAT PROCEDURE ON A DIFFERENT DATE WAS NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764756 ↗
• MalfunctionApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RADIO FREQUENCY ABLATION OF BARRETT'S ESOPHAGUS FOLLOWING A BALLOON ABLATION OF A PROXIMAL SEGMENT OF ESOPHAGUS, THERE WAS A BLEEDING ON THE WALL OF THE ESOPHAGUS. AFTER SUCCESSFULLY REMOVING THE CATHETER WITHOUT INCIDENT, THE PHYSICIAN IRRIGATED AND INSPECTED THE BLEEDING AREA AND THERE APPEARED TO BE AN ESOPHAGEAL TEAR ON THE WALL OF THE ESOPHAGUS. AFTER CONTINUED INSPECTION AND IRRIGATION, THE BLEEDING STOPPED. IT WAS DETERMINED THAT HEMOCLIPS WERE NOT NEEDED. THE PHYSICIAN DECIDED TO DISCONTINUE THE PROCEDURE.

  Patient problems: Laceration(s) of Esophagus; No Code Available

  MAUDE report 8495840 ↗
• InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER HAD KINKED COILS AFTER THE FIRST PASS AND IT CAUSED LACERATIONS IN CERVICAL ESOPHAGUS. IT WAS NOTED THAT THE GENERATOR DISPLAYED AN ERROR CODE, BUT THEY WERE UNABLE TO RECALL THE SPECIFIC CODE. THERE WERE NO LOOSE COMPONENTS AND THE SOFTWARE WAS NOT UPGRADED. IT WAS DETERMINED THAT THE LACERATION IN THE CERVICAL ESOPHAGUS (BETWEEN C7 AND T1) OCCURRED AFTER THE FIRST SET OF ABLATION, PROBABLY DUE TO THE LACK OF CLOCKWISE TURN ON THE REMOVAL OF THE CATHETER. THE BALLOON DID NOT LOOK DEFLATED. WHEN THE PHYSICIAN WENT BACK WITH THE SCOPE, THE LACERATION WAS THEN NOTICED. THE DOCTOR AND THE TECHNICIAN WERE NOT AWARE OF THE CORRECT PROCEDURE TO FOLLOW. THE BARETT¿S ESOPHAGUS WAS 4 CM LONG WITH NO DYSPLASIA. THE PATIENT STILL COMPLAINED OF SOME ODYNOPHAGIA AFTER DISCHARGE AND WAS KEPT ON LIQUID DIET. THE LACERATION WAS NOT CLIPPED BUT WAS MONITORED BY THE PHYSICIAN WITH A CT SCAN. THE PATIENT WILL BE SEEN, AND THE ASSISTANCE OF A REPRESENTATIVE WAS REQUESTED AND SCHEDULED. THERE PATIENT WAS STABLE AND WILL BE RESCHEDULED IN 3 MONTHS. THERE WAS NO USER HARM.

  Patient problems: Laceration(s) of Esophagus; Radiation Exposure, Unintended

  MAUDE report 8450061 ↗
• InjuryOct 5, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE OF BARRX FOR HIGH GRADE DYSPLASIA, THE CATHETER FAILED TO INFLATE. THE CATHETER WILL BE RETURNED FOR INVESTIGATION. TWO WEEKS POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR GASTROINTESTINAL BLEEDING FROM ESOPHAGUS AND WAS ON ANTI-COAGULANT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7939708 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE RADIOFREQUENCY ABLATION PROCEDURE, THE PATIENT HAD AN ESOPHAGEAL STENOSIS AND NO MEDICAL INTERVENTION WAS DONE. THE PATIENT WAS ENROLLED IN A STUDY AND THERE WAS NO PATIENT INJURY.

  Patient problems: Stenosis

  MAUDE report 7869060 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST RADIO FREQUENCY ABLATION PROCEDURE, THE PATIENT EXPERIENCED DYSPHAGIA TWICE AND IT WAS CONSIDERED TO BE AN ESOPHAGEAL STENOSIS. ESOPHAGEAL DILATION WAS REQUIRED SCHEDULED ON A DIFFERENT DAY. THE SIZE OF ESOPHAGEAL MEASURED AS 25 MM IN 24-32 CM, 18 MM IN 20 CM. SO THEY CONDUCTED A RADIO FREQUENCY ABLATION IN 26-32 CM USING BARRX-360 25 MM, THEN EXITED THE MEASURING BALLOON, CONDUCTED RFA ABLATION IN 20-26 CM USING BARRX-360 18 MM. EACH ABLATION CATHETER WAS ABLATED TWICE, SO IT WAS ABLATED FOUR TIMES. ENDOSCOPY HAS BEEN PERFORMED PRIOR TO CATHETER INTUBATION AND FOUND NO VARICES, ESOPHAGITIS, ONLY THE ESOPHAGEAL SIZE WAS 18 MM IN THE SECTION OF 20 CM AFTER MEASURED BY THE BALLOON CATHETER. THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE, NO DEVICE MALFUNCTION WAS NOTICED. WHEN ESOPHAGEAL DILATION WAS PERFORMED, THEY NOTED THAT THE STENOSIS AREA ON THE ESOPHAGEAL WAS 25 CM. THEY THEN INSERTED THE DILATION GUIDE WIRE, BUT THE 9.9 MM ENDOSCOPY COULD NOT GO ACROSS THE STENOSIS AREA. THEY USED A 7 MM BOUGIE (A THIN AND FLEXIBLE SURGICAL INSTRUMENT) AND TRIED TO INSERT THE 9 MM ENDOSCOPY TO HAVE ANOTHER DILATION, BUT THE ENDOSCOPY CAN NOT GO CROSS. THE PATIEN

  Patient problems: Dysphagia/ Odynophagia; Laceration(s) of Esophagus; Stenosis

  MAUDE report 7813343 ↗
• MalfunctionJun 12, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE, THE GENERATOR DISPLAYED AN ERROR CODE. THE CUSTOMER ATTEMPTED TO USE SEVERAL CATHETERS, BUT IT DISPLAYED ¿NO TISSUE CONTACT¿. THEY USED APC (ARGON PLASMA COAGULATION) PROCEDURE TO CORRECT THE PROBLEM. A REPEAT PROCEDURE WAS PERFORMED ON A DIFFERENT DAY DUE TO THE MALFUNCTION. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. THE LAST KNOWN PATIENT STATUS WAS STABLE AND THE DEVICE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7591368 ↗
• MalfunctionApr 26, 2018Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE WAS DEFECTIVE DURING A RADIOFREQUENCY ABLATION OF BARRETT'S ESOPHAGUS WHICH CAUSED MUCOSAL LACERATION APPROXIMATELY 1 CM ON THE SECOND PASS FROM 35-36CM WHILE THE PHYSICIAN WAS DESCRIBING THE PROCEDURE UNDER DIRECT VISUALIZATION. INHALATION/ORAL DRUG WAS USED. THE CATHETER WAS ADVANCED ROTATING CLOCKWISE, TREATING 8CM PROXIMAL TO DISTAL. ALL ITEMS WERE REM OVED UNDER DIRECT VISUALIZATION BY ROTATING THE CATHETER CLOCKWISE, AND A CLEANING CUP WAS USED TO SCRAPE THE COAGULUM. THE GUIDE WIRE WAS ADVANCED, SCOPE WAS WITHDRAWN, AND THE CATHETER ADVANCED ROTATING CLOCKWISE, THEN RETREATED 8CM AREA. EVERYTHING WAS REMOVED UNDER DIRECT VISUALIZATION, AND THE SCOPE WAS ADVANCED TO EVACUATE GASTRIC CONTENTS, THEN A 1 CM ESOPHAGEAL TEAR WAS IDENTIFIED. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA, WAS THEN NORMAL AND WAS GIVEN PAIN MEDICATIONS, NO REPEAT PROCEDURE WOULD BE NECESSARY. THERE WAS NO RADIATION EXPOSURE, UNANTICIPATED BLOOD LOSS, NOR DEVICE FRAGMENT OR COMPONENT FELL INTO THE PATIENT'S CAVITY.

  Patient problems: Laceration(s)

  MAUDE report 7464765 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092487. One submission often covers many models, so check the product and lot details in each record.

• Z-2379-2012 · Aug 3, 2012 · Terminated
  HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagu