Barrx 64082-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521211599), received between Nov 15, 2016 and Feb 20, 2026 — classified as 22 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (10 reports).

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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BRAND-NEW CATHETER APPEARED USED UPON OPENING. IT HAD A REDDISH-BROWN SUBSTANCE INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400595 ↗
• MalfunctionDec 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BRAND NEW AND UNOPENED CATHETER HAD BLOOD INSIDE THE SEALED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767907 ↗
• MalfunctionJul 18, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT AFTER THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE FOR BARRETT¿S ESOPHAGUS, DURING EXTRACTION IN CLOCKWISE ROTARY MOTION, THE DEVICE STILL UNWOUND. THERE WAS TEMPORARY INJURY OF BLEEDING AS THERE WAS SLIGHT ABRASION IN THE ESOPHAGUS TO WHICH ADRENALINE INJECTION WAS GIVEN AS AN INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s) of Esophagus

  MAUDE report 22543013 ↗
• MalfunctionJun 30, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT THE CATHETER COILED AND BECAME STUCK IN THE PATIENT, SPECIFICALLY AT THE LOWER ESOPHAGEAL SPHINCTER. MINOR BLEEDING OCCURRED, WHICH WAS REPORTED AS NORMAL FOR THE PROCEDURE. A SCOPE WAS INSERTED AND USED TO VISUALIZE THE CATHETER'S POSITION AND ASSIST IN ITS REMOVAL. THE CATHETER WAS SUCCESSFULLY RELEASED AND REMOVED FROM THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22357141 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT DEVELOPED A MAJOR BLEED FOLLOWING RADIO FREQUENCY ABLATION TREATMENT ON THE (B)(6) PRESENTED TO HOSPITAL WITH C/O VOMITING BLOOD (ABOUT 1 PINT) A WEEK AFTER HAVING HALOTHERAPY. ALSO, C/O FEELING SHORT OF BREATH AND BEING NAUSEOUS, WITH SOME EPIGASTRIC PAIN, AND HAVING BLACK STOOLS. ON EXAMINATION HE WAS QUITE PALE, AND HEMODYNAMICALLY UNSTABLE. PATIENT WAS RESUSCITATED WITH BLOOD AND PLASMA TRANSFUSION AND WAS TREATED WITH IV PPI AND WAS TAKEN FOR URGENT OGD, WHICH SHOWED A LARGE UGI BLEED SECONDARY TO ULCER, AND WAS ENDO-CLIPPED. TWO DAYS POST-OPERATIVE, THE PATIENT WAS ADMITTED TO A LOCAL HOSPITAL¿S INTENSIVE THERAPY UNIT WITH A MAJOR BLEED. THE PATIENT UNDERWENT ANOTHER RADIO FREQUENCY ABLATION ON THE (B)(6) TO TREAT (B)(6) OESOPHAGUS AND DEVELOPED ANOTHER MAJOR BLEED ON THE (B)(6), LEADING TO ANOTHER HOSPITAL ADMISSION. AS OF THE (B)(6), THE PATIENT WAS STILL IN THE INTENSIVE THERAPY UNIT. NOTHING ABNORMAL WAS NOTED DURING THE RADIO FREQUENCY ABLATION OR IMMEDIATELY AFTER THE PROCEDURE. A NEW CATHETER WAS USED FOR EACH ABLATION. THE TECHNIQUE USED TO ABLATE THE TISSUE WAS (B)(6) 2024 C10 M10 30-40 CM TREATED WITH CIRCUMFERENTIAL (APP, SCRA

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 20026316 ↗
• MalfunctionJun 21, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, UPON REMOVAL OF THE CATHETER, IT WAS DISCOVERED THAT THE BALLOON HAD DEFLATED BUT THE METAL COIL DID NOT WRAP ITSELF AROUND THE DEFLATED BALLOON. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589468 ↗
• MalfunctionJun 21, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, UPON REMOVAL OF THE CATHETER, IT WAS DISCOVERED THAT THE BALLOON HAD DEFLATED BUT THE METAL COIL DID NOT WRAP ITSELF AROUND THE DEFLATED BALLOON. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588668 ↗
• MalfunctionJun 21, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, UPON REMOVAL OF THE CATHETER, IT WAS DISCOVERED THAT THE BALLOON HAD DEFLATED BUT THE METAL COIL DID NOT WRAP ITSELF AROUND THE DEFLATED BALLOON. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585370 ↗
• MalfunctionMay 17, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE BALLOON DID DEFLATE AND THE ELECTRODE DID NOT CURL AROUND BALLOON. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345158 ↗
• MalfunctionMay 6, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE ELECTRODE DID NOT CURL AROUND THE BALLOON. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250770 ↗
• InjuryFeb 26, 2024Deflation Problem; Unraveled Material; Insufficient Device Problem Information; Deflation Problem; Unraveled Material; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER ELECTRODE STILL ATTACHED TO THE BALLOON, HOWEVER LOOKED ABNORMAL. IT DID NOT DEFLATE ALL THE WAY. THE ESOPHAGUS OF THE PATIENT WAS PERFORATED WHILE EXTUBATING. PATIENT WAS IN INTENSIVE CARE UNIT (ICU).

  Patient problems: Perforation of Esophagus

  MAUDE report 18778194 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  ACCORDING TO THE REPORTER, THE PATIENT HAD A LACERATION WHEN THE CATHETER WAS REMOVED AFTER ABLATION PROCEDURE AND UPON EXAMINATION, THE BALLOON CATHETER BROKE OR WAS NOT INTACT. THE SCOPE WAS ADVANCED INTO THE ESOPHAGUS TO FIND THE PIECE OF BALLOON AND IT WAS STILL IN THE ESOPHAGUS. THE PIECE OF BALLOON WAS REMOVED. SUPERFICIAL MUCOSAL INVOLVEMENT, APPROXIMATELY 5 CM, BUT WITH BLOOD AND MUCUS EXACT MEASUREMENT NOT POSSIBLE, BUT APPEARED SUPERFICIAL. ACCORDING TO MEDICAL STAFF, AN ESOPHAGEAL STENT WAS PLACED ON PATIENT. AN X-RAY AND BARIUM SWALLOW WAS PERFORMED AFTER THE REMOVAL OF THE STENT. PATIENT STAYED A COUPLE OF DAYS DUE TO INITIAL NAUSEA. PATIENT WAS NOTED TO BE FINE AND IN RECOVERY.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 18763949 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS EXPERIENCING LARYNGOSPASM POST RFA (RADIOFREQUENCY ABLATION). ENT SUSPECTED NERVE DAMAGE. AFTER INTERVENTIONS, ANESTHESIA COULD NOT CONTROL THE SPASMS MEDICALLY OR MANUALLY. PATIENT HAD TO BE INTUBATED AGAIN AND HAS SINCE BEEN IN THE ICU. PATIENT DEVELOPED STRIDOR, WAS GIVEN STEROID, AND WOUND UP BEING RE-INTUBATED. PATIENT WAS ALSO GIVEN EPINEPHRINE AT SOME POINT. ENT HAD PERFORMED LARYNGOSCOPY WHILE THE PATIENT WAS INTUBATED. THE AREA APPEARED EDEMATOUS, WITH NO FOCAL LACERATION IDENTIFIED. EVENTUALLY, AN ATTEMPT TO EXTUBATE WAS UNSUCCESSFUL. ANOTHER ENDOSCOPY WAS PERFORMED AROUND THIS TIME AND VISUALLY EVALUATED AREA OF PRIOR ABLATION. THERE WAS NO FOCAL LACERATION IDENTIFIED IN THE AREA OF TREATMENT. THERE HAD BEEN A PLAN TO EXTUBATE BUT THE PATIENT WOUND UP DEVELOPING A FEVER, AND DECISION WAS MADE TO HOLD OFF. THE PATIENT WAS NOT TOLERATING BEING EXTUBATED PARTICULARLY WELL AND WOUND UP BEING TRACHED. HAD ANOTHER LARYNGOSCOPY, AND THE ENT PHYSICIAN DID NOT SEEM TO FEEL LIKE THIS WAS TRAUMATIC. ENT SEEMED TO THINK IT WAS PLAUSIBLE THAT IT WAS RFA RELATED. PATIENT TRACHED AND FENESTRATED. SPEECH THERAPY HAS BEEN INVOLVED.

  Patient problems: Airway Obstruction; Fever; Swelling/ Edema; Upper Respiratory Tract Injury

  MAUDE report 18485218 ↗
• MalfunctionDec 28, 2023Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE FOR BARRETT¿S ESOPHAGUS, THE BALLOON WAS FILLED WITH AIR, BUT WOULD NOT ACHIEVE THE PROPER SIZE WHICH SIGNALS THE PHYSICIAN TO DO THE ABLATION. THE CATHETER WAS REMOVED AND A DEFECT WAS NOTICED. ABLATION WAS NEVER DELIVERED WITH THE DEFECTIVE DEVICE. THE COIL WAS BENT INWARD WHICH WOULD BLOCK THE BALLOON FROM ACHIEVING FULL VOLUME. A DIFFERENT CATHETER WAS USED TO PERFORM THE CASE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414003 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE BARRETT'S ESOPHAGUS RADIOFREQUENCY ABLATION PROCEDURE THE PATIENT DEVELOPED OCCIPITAL REGION HEADACHE FOR A MONTH AFTER THE ORIGINAL RADIOFREQUENCY ABLATION PROCEDURE. THE OCCIPITAL HEADACHE EVENTUALLY WENT AWAY BUT RETURNED AFTER THE NEXT ROUND OF TREATMENT. MAC ANESTHESIA WAS USED DURING THE PROCEDURE. THE PATIENT UNDERGO AN MRI AND NEUROLOGY VISIT.

  Patient problems: Headache

  MAUDE report 17007182 ↗
• MalfunctionFeb 22, 2022Therapeutic or Diagnostic Output Failure

  COVIDIEN BARRX 360 RFA (RADIOFREQUENCY ABLATION) BALLOON CATHETER MALFUNCTION. DURING THE PROCEDURE, THE CATHETER STOPPED WORKING WHILE IT WAS BEING USED. ABLE TO DO 3 TREATMENTS AND THEN IT STOPPED DURING THE FOURTH INFLATION AND ABLATION. TRIED TROUBLESHOOTING THE DEVICE, BUT WAS UNABLE TO GET IT WORKING AGAIN. OPENED ANOTHER RFA BALLOON CATHETER FROM THE SAME LOT AND THAT ONE WORKED WITH NO FAULTS. NO HARM TO PT, PROCEDURE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577098 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A CIRCUMFERENTIAL ABLATION OF THE ESOPHAGUS AND BY THE TIME THE DOCTOR REMOVED THE CATHETER IT HIT THE ESOPHAGUS AND CREATED PERFORATION. PATIENT HAD NO ACTIVE ESOPHAGITIS, EROSIONS OR ULCERATIONS. NORMAL OVERLAP OF 1 CM WAS APPLIED IN EACH ABLATION. THEY PUT A COATED STENT WITH MIGRATION PREVENTION MECHANISM TO THE ESOPHAGEAL PERFORATION AND REMOVED AFTER 5 DAYS.

  Patient problems: Perforation of Esophagus

  MAUDE report 13118247 ↗
• InjuryNov 10, 2021Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, THE CATHETER WAS USED ON PATIENT FOR THREE ABLATIONS AND ON REMOVAL FROM PATIENT, THERE WAS A RESISTANCE NOTED. THE GASTROSCOPE WAS REINSERTED TO EXAMINE THE MUCOSA AND IT WAS NOTED THAT THERE WAS A DEEP MUCOSAL INJURY. IT WAS NOTICED THE CATHETER ELECTRODE HAD BECOME UNRAVELED AND CAUSED DAMAGE TO THE PATIENT. A METAL STENT WAS INSERTED AND AIR/ESOPHAGEAL CONTENTS SUCTIONED. PATIENT WAS ADMITTED OVERNIGHT AS A RESULT.

  Patient problems: Laceration(s)

  MAUDE report 12787890 ↗
• MalfunctionNov 2, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE CATHETER BALLOON UNRAVELED DURING THE PROCEDURE. THE CATHETER CAUSED MINOR BLEEDING TO THE ESOPHAGUS. THERE WAS NO MEDICAL INTERVENTION DONE FOR THE MINOR BLEEDING. THE PROCEDURE BEING PERFORMED WAS EGD (ESOPHAGOGASTRODUODENOSCOPY) RFA (RADIOFREQUENCY ABLATION).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12739940 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A MONTH AFTER THE PROCEDURE, THE PATIENT DEVELOPED STRICTURES. DILATIONS WERE PERFORMED FOR THE STRICTURES. THE CUSTOMER WOULD LIKE TO KNOW IF A MONTH IS SAFE TO TREAT STRICTURES.

  Patient problems: Stenosis

  MAUDE report 12068068 ↗
• MalfunctionApr 20, 2021Inflation Problem; Device Displays Incorrect Message

  COVIDIEN BARRX 360 EXPRESS RFA BALLOON CATHETER WOULD NOT INFLATE AND READING FAULTY CATHETER, OPENED ANOTHER CATHETER AND IT DID THE SAME.

  Patient problems: Insufficient Information

  MAUDE report 11692638 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED NOVEMBER 2015 TO NOVEMBER 2017, RADIO-FREQUENCY ABLATION (RFA) FOR BARRETT¿S OESOPHAGUS (BE)-RELATED NEOPLASIA WAS DONE TO PRESENT REAL WORLD DATA ON THE USE OF THE 360 EXPRESS CATHETER. THE AIM OF THIS STUDY WAS TO RETROSPECTIVELY EVALUATE THE EFFICACY AND SAFETY (IN TERMS OF STRICTURE FORMATION) OF THE 360 EXPRESS RFA BALLOON CATHETER. THERE WERE 123 PATIENTS AND 112 OF THEM HAD A FOLLOW UP ENDOSCOPY. THE MEDIAN AGE WAS 67 YEARS. OUT OF 112 PATIENTS, 5 PATIENTS (15%) DEVELOPED STRICTURES REQUIRING DILATION. THE PRIMARY OUTCOME WAS THE SURFACE REGRESSION OF BARRETT¿S OESOPHAGUS AT 3 MONTHS AS CALCULATED BY % CHANGE IN CIRCUMFERENTIAL. THE 5 PATIENTS DEVELOPED ESOPHAGEAL STRICTURES THAT WERE SYMPTOMATIC, AND WHICH REQUIRED ENDOSCOPIC DILATION. THE MEDIAN NUMBER OF DILATIONS REQUIRED TO RESOLVE WAS 2 AND ALTHOUGH 2 PATIENTS REQUIRED 5 DILATIONS, MOST WERE NOT REFRACTORY STRICTURES AND WERE THEREFORE AMENABLE TO ENDOSCOPIC BALLOON DILATATION TO ALLOW ALLEVIATION OF THE RESULTANT DYSPHAGIA. SECONDARY ANALYSIS WAS PERFORMED TO ASSESS IF STRICTURE FORMATION WAS RELATED TO THE TREATMENT REGIMEN USED. THE 12 J/CM2 ENERGY SETTING WAS ASSOCI

  Patient problems: Stenosis

  MAUDE report 11627286 ↗
• MalfunctionMar 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE WAS INTRODUCED OVER THE GUIDEWIRE AND PLACED AT THE PROXIMAL EXTENT OF THE ESOPHAGUS UNDER ENDOSCOPIC VISUALIZATION. THE CONNECTING ADAPTER CORD BECAME DISLODGED AFTER THE BALLOON DISTENDED. UPON RECONNECTING THE CORD AND DEFLATING THE BALLOON A TEAR WAS IDENTIFIED AT 32CM IN THE 3 O' CLOCK POSITION. THE TEAR WAS EXTENDED TO MUSCULARIS. THE BLEEDING STOPPED SPONTANEOUSLY AFTER A FEW MINUTES. ABLATION AT 320 W AND 10 J/CM2 WAS PERFORMED IN 4-CM INCREMENTS STARTING AT 33 CM IN ORDER TO AVOID THE TEAR. REPEAT ABLATION WAS PERFORMED AFTER CLEARING THE ABLATION ZONE AND PATIENT WAS MOVED TO RECOVERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 11593635 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN RFA (RADIO FREQUENCY ABLATION) PROCEDURE. THE PATIENT WAS TREATED ON A SEGMENT C4M6 OF THE ESOPHAGUS. ON THE FOLLOW UP VISIT, THE SURGEON OBSERVED A STRICTURE THAT HAD TO BE DILATED. A DILATION OF STRICTURE WAS DONE AS A MEDICAL INTERVENTION. NO HOSPITALIZATION AND NO REPEAT PROCEDURE WAS NEEDED. THERE WAS NO USER HARM.

  Patient problems: Stenosis

  MAUDE report 11327237 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN RFA (RADIO FREQUENCY ABLATION) PROCEDURE. THE PATIENT WAS TREATED ON A SEGMENT C15M15 OF THE ESOPHAGUS. ON THE FOLLOW UP VISIT, THE SURGEON OBSERVED A STRICTURE THAT HAD TO BE DILATED. A DILATION OF STRICTURE WAS DONE AS A MEDICAL INTERVENTION. NO HOSPITALIZATION AND NO REPEAT PROCEDURE WAS NEEDED. THERE WAS NO USER HARM.

  Patient problems: Stenosis

  MAUDE report 11327215 ↗