BarrxRecalls & reported problems across all models
Covidien LP · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Barrx model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 106
- Deaths reported
- 1
- Injuries reported
- 68
- Recalls
- 1
We found 19 models of Barrx by Covidien LP in the FDA's device registry (GUDID). Together they are named in 106 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Sep 2, 2026 — classified as 1 death, 68 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Barrx recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 2, 2023Open, Classified
Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.
Z-2282-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported Barrx problems
Device problems
- Adverse Event Without Identified Device or Use Problem46
- Insufficient Device Problem Information11
- Unraveled Material11
- Inflation Problem9
- Difficult to Remove7
- Device Displays Incorrect Message6
- Break4
- Connection Problem3
Patient problems
- Laceration(s) of Esophagus18
- No Clinical Signs, Symptoms or Conditions17
- Hemorrhage/Blood Loss/Bleeding11
- Stenosis11
- Chest Pain10
- Dysphagia/ Odynophagia9
- No Consequences Or Impact To Patient9
- Pain8
Barrx models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Barrx CYTO-KIT-USMFIXATIVE, ALCOHOL CONTAINING1 recall0 reports
- Barrx 64082-01ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES41 reports
- Barrx 1190A-115AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES11 reports
- Barrx 64082Electrosurgical, cutting & coagulation & accessories9 reports
- Barrx TTS-1100ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES7 reports
- Barrx 90-9200ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 death7 reports
- Barrx 90-9100ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Barrx FLEXFS-010AElectrosurgical, cutting & coagulation & accessories4 reports
- Barrx FLEXCC-020AElectrosurgical, cutting & coagulation & accessories3 reports
- Barrx 32041-25ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Barrx TTS-1100Electrosurgical, cutting & coagulation & accessories3 reports
- Barrx 1190A-230AElectrosurgical, cutting & coagulation & accessories2 reports
- Barrx 32041-22ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Barrx 90-9300ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Barrx 1190A-230AElectrosurgical, cutting & coagulation & accessories2 reports
- Barrx 32041-18-01Electrosurgical, Cutting & Coagulation & Accessories1 report
- Barrx 32041-28ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Barrx CP-002AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Barrx GW-002BTUBES, GASTROINTESTINAL (AND ACCESSORIES)1 report
Recent Barrx adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564664 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHILE PERFORMING RADIOFREQUENCY ABLATION AT 48 WATTS AND 12 JOULES, AN EPISODE OF SINUS ARRHYTHMIA WAS NOTED. IMMEDIATE STABILIZATION PROTOCOLS WERE FOLLOWED TO WHICH THE ANESTHESIOLOGIST ADMINISTERED MAGNESIUM, LIDOCAINE, ESMOLOL, AND BUTYL HYOSCINE, ALLOWING FOR THE COMPLETION OF THE PROCEDURE. POST-PROCEDURAL EVALUATION CONFIRMED THE PATIENT WAS STABLE. THERE WERE NO LOOSE COMPONENTS.
Patient problems: Arrhythmia
MAUDE report 25149989 ↗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 ↗InjuryNov 21, 2025Smoking; Sparking; Insufficient Device Problem Information; Smoking; Sparking; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING RADIO FREQUENCY ABLATION (RFA) PROCEDURE FOR SQUAMOUS INTRAEPITHELIAL NEOPLASIA, THE CATHETER ELECTRODE SPARKED UNDER ENDOSCOPY, AT THE ABLATION ELECTRODE SITE, AND SMOKE WAS OBSERVED. THE LEAD WAS REMOVED AND SURGERY WAS STOPPED. AFTER THE ELECTRODE WAS WITHDRAWN, DAMAGE WAS OBSERVED ON THE ELECTRODE SURFACE. THERE WAS NO PATIENT OR USER HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23616839 ↗InjuryNov 7, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
IT WAS REPORTED THAT DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, AFTER THE SECOND ROUND OF TREATMENT, A RESISTANCE WAS ENCOUNTERED WHEN TRYING TO REMOVE THE CATHETER FOR THE FINAL TIME. UNDER VISUALIZATION, THE ELECTRODE DID SEEM TO BE UNRAVELED. DOCTOR WAS FURTHER INSTRUCTED TO ROTATE THE CATHETER CLOCKWISE WHEN INTRODUCING AND REMOVING THE CATHETER WHICH RESOLVED THE ISSUE. THE PATIENT HAD TO UNDERGO CT SCAN AND SEEN A "SMALL DEFECT IN ESOPHAGUS T4-T5" WHICH WAS DONE NEXT DAY. THE PATIENT HAD TO EXTEND THE LENGTH OF STAY FOR 7 DAYS AND WAS ON CLEAR FLUIDS FOR 6 DAYS AND FULL FLUID DIET ON THE (B)(6). NO OTHER SURGICAL INTERVENTION NOTED AND NO ADDITIONAL PROCEDURES WERE NOTED IN HOSPITAL RECORDS.
Patient problems: Perforation of Esophagus
MAUDE report 23496309 ↗InjurySep 11, 2025Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, THE DOCTOR STARTED TO APPLY THE THERAPY TO THE PATIENT. BUT FOR SOME REASON THE DELIVERY OF THE ENERGY FROM THE CATHETER TO THE PATIENT'S ESOPHAGUS MUCOSA FAILED. THE CASE WAS CANCELED AND WAS REPEATED TWO WEEKS LATER WHEN IT WAS COMPLETED WITHOUT ANY ISSUES WITH ANOTHER GENERATOR. THE PATIENT UNDERWENT IV SEDATION ON BOTH INITIAL AND SECOND PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031145 ↗InjurySep 11, 2025Power Problem; Power Problem
IT WAS REPORTED THAT DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, THE DOCTOR STARTED TO APPLY THE THERAPY TO THE PATIENT. BUT FOR SOME REASON THE DELIVERY OF THE ENERGY FROM THE CATHETER TO THE PATIENT'S ESOPHAGUS MUCOSA FAILED. THE CASE WAS CANCELED AND WAS REPEATED TWO WEEKS LATER WHEN IT WAS COMPLETED WITHOUT ANY ISSUES WITH ANOTHER GENERATOR. THE PATIENT UNDERWENT IV SEDATION ON BOTH INITIAL AND SECOND PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031144 ↗InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST OPERATIVE A RADIO FREQUENCY ABLATION, AFTER DILATING THE ESOPHAGUS A STRICTURE AREA REMAINS. IT WAS ALSO REPORTED THAT THE PATIENT HAD EXPERIENCED SEVERE ESOPHAGEAL INFLAMMATION, PAIN AND SYSTEMIC REACTION WITH ELEVATED C-REACTIVE PROTEIN (CRP) AND PLEURAL EFFUSIONS. THE PATIENT WAS ADMITTED ACUTELY AND MEDICAL INTERVENTION WAS PERFORMED.
Patient problems: Inflammation; Pain; Pleural Effusion
MAUDE report 22939256 ↗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 ↗InjuryJul 24, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE FOR THE TREATMENT OF RADIATION PROCTITIS, THE CATHETER DID NOT ACTIVATE. IT DISPLAYED AN E92 ERROR MESSAGE AND INSTRUCTED TO CLEAN THE PROBE AND RESET THE MACHINE. IT WAS CLEANED AND THE MACHINE WAS RESTARTED TWICE AS INSTRUCTED BY THE MACHINE. THE PATIENT HAD SEDATION AND ENDOSCOPY DURING THE INITIAL PROCEDURE AND WAS BROUGHT BACK THE NEXT DAY TO COMPLETE THE TREATMENT WITH ANOTHER CATHETER AND ALSO REQUIRED SEDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584765 ↗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 ↗MalfunctionJun 26, 2025Failure to Unfold or Unwrap; Premature Separation; Failure to Unfold or Unwrap; Premature Separation
IT WAS REPORTED THAT DURING TWO TIMES RADIOFREQUENCY ABLATION (RFA) IN THE ESOPHAGUS AFTER BARRETT CARCINOMA FOR ERADICATION OF BARRETT (9 CENTIMETER), LEGE ARTIS. IN EACH CASE IN THREE STEPS, EVERY FOUR CENTIMETER FROM PROXIMAL TO DISTAL, DURING THE SIXTH AND LAST RADIOFREQUENCY ABLATION, THE ELECTRODE PARTIALLY DETACHED FROM THE SELF-EXPANDING BALLOON CATHETER AND WAS NOT REWRAPPED ONTO THE BALLOON UPON BALLOON DEFLATION, SO THAT THE ROLLED-UP ELECTRODE CAME TO LIE NEXT TO THE DEFLATED BALLOON. IMMEDIATELY AFTERWARD, SLIGHT OOZING BLEEDING OF THE ESOPHAGUS WAS OBSERVED, WHICH, HOWEVER, WAS NOT NECESSARILY ATTRIBUTABLE TO THE DYSFUNCTION, AS IT COULD ALSO BE EXPECTED PER SE AFTER TWICE-PERFORMED RADIOFREQUENCY ABLATION. THE CATHETER WAS CAREFULLY REMOVED FROM THE ESOPHAGUS TO RESOLVE THE ISSUE. THERE WAS NO EVIDENCE OF PERFORATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22337019 ↗InjuryMay 13, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PATIENT WAS ALREADY PREPPED AND SEDATED INTRAVENOUSLY BUT THE BALLOON CATHETER DID NOT INFLATE AND AN AIR LEAK ERROR MESSAGE WAS DISPLAYED. THE HEALTHCARE PROFESSIONAL ATTEMPTED TO USE A SECOND CATHETER BUT ALSO FAILED TO INFLATE. AFTER TWO CATHETERS WERE USED AND FAILED, THE THERAPY WAS STOPPED AND THE PATIENT WAS RESCHEDULED. THE PATIENT HAD UNDERGONE ADDITIONAL PROCEDURE WITH INTRAVENOUS SEDATION AND ENDOSCOPY.
Patient problems: Insufficient Information
MAUDE report 22015737 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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