ClariFix CFX-2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00850002250404), received between Oct 12, 2022 and Apr 22, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Free or Unrestricted Flow” (9 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Free or Unrestricted Flow

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 10 EVENTS FOR THE FAILURE: FREE OR UNRESTRICTED FLOW. 10 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954401 ↗
• MalfunctionOct 28, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 15 EVENTS FOR THE FAILURE: FREE OR UNRESTRICTED FLOW. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 13 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD CODE NOT FOUND!

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 23399782 ↗
• InjuryOct 16, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  NO NEW INFORMATION.

  Patient problems: Cryogenic Burn; Epistaxis; Perforation

  MAUDE report 23313963 ↗
• MalfunctionJul 29, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30 2025. THIS REPORT SUMMARIZES 15 EVENTS FOR THE FAILURE: FREE OR UNRESTRICTED FLOW. 15 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647413 ↗
• MalfunctionApr 21, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  THIS REPORT SUMMARIZES 12 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD FREE OR UNRESTRICTED FLOW. 10 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT. 1 EVENT REQUIRED MEDICATION BE PROVIDED. 1 EVENT HAD A CANCELLED/ABORTED SURGICAL PROCEDURE.

  Patient problems: Headache; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876292 ↗
• MalfunctionJan 22, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD FREE OR UNRESTRICTED FLOW. 6 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS HAD A CANCELLED/ABORTED SURGICAL PROCEDURE. 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208067 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44 YR OLD FEMALE PATIENT UNDERWENT CLARIFIX CRYOTHERAPY IN CONJUNCTION WITH A SEPTO/TURB PROCEDURE PRESENTED WITH POST OPERATIVE BLEED AT SITE OF CLARIFIX CRYOTHERAPY 17 DAYS POST PROCEDURE. THERE WERE NO COMPLICATIONS NOTED AT TIME OF THE INITIAL SURGERY. THE PATIENT HAS BEEN TAKING MODERATELY HIGH AMOUNTS OF ASPIRIN WHICH MAY INCREASE THE RISK OF BLEEDING AS LISTED IN THE LABELING AS A POTENTIAL SIDE EFFECT. THE PHYSICIAN TREATED THE PATIENT IN THE OR TO CAUTERIZE THE SPHENOPALATINE ARTERY AND ADJACENT MUCOSAL OOZING IN THE NOSE. THE PATIENT WAS HOSPITALIZED OVERNIGHT POST PROCEDURE. THERE HAS BEEN NO ADDITIONAL NASAL BLEEDING POST OPERATION AND THE PATIENT WAS NOTED TO BE RECOVERING WELL WITH NO PERMANENT DAMAGE WAS REPORTED.

  Patient problems: Epistaxis

  MAUDE report 20855753 ↗
• MalfunctionOct 21, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD FREE OR UNRESTRICTED FLOW. - 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494164 ↗
• MalfunctionJul 24, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD FREE OR UNRESTRICTED FLOW. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818710 ↗
• MalfunctionJun 12, 2024Free or Unrestricted Flow; Mechanical Jam; Free or Unrestricted Flow; Mechanical Jam

  IT WAS REPORTED THAT DURING CRYOGEN DELIVERY AT THE USER FACILITY THE DEVICE COULD NOT BE SHUT OFF, POTENTIALLY EXPOSING THE PATIENT TO EXCESSIVE CRYOGEN DELIVERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522227 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE WEEK AFTER THE PATIENT WAS TREATED WITH THE CRYOTHERAPY DEVICE THE PATIENT STARTED EXPERIENCING EPISTAXIS AND TWO WEEK AFTER THE PROCEDURE THE PATIENT HAD SEVERE EPISTAXIS AND WAS TREATED WITH ELECTROCOAGULATION. THE BLEEDING WAS REPORTED TO BE COMING FROM THE BRANCH OF THE SPHENOPALATINE ARTERY, WHICH WAS LOCATED AT THE TREATMENT SITE. NO ADDITIONAL EPISTAXIS HAS OCCURRED AND NO PERMANENT DAMAGE WAS REPORTED.

  Patient problems: Epistaxis

  MAUDE report 16965190 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR WEEKS AFTER A BILATERAL SEPTO TURB PROCEDURE WITH CRYOTHERAPY THE PATIENT EXPERIENCED EPISTAXIS. THE PATIENT WORE DOYLE SPLINTS FOR 5 DAYS AND THEN THE DOCTOR TOOK THE PATIENT INTO SURGERY AND CAUTERIZED THE BLEED. NO ADDITIONAL EPISTAXIS HAS OCCURRED AND NO PERMANENT DAMAGE WAS REPORTED.

  Patient problems: Epistaxis

  MAUDE report 15591362 ↗