ClariFix CFX-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00868438000234), received between Aug 11, 2020 and Apr 26, 2021 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD A CLARIFIX PROCEDURE AND CONCOMITANT POLYP REMOVAL ON (B)(6) 2021. FOUR WEEKS POST OP, ON (B)(6) 2021, THE PATIENT PRESENTED WITH SOME BLEEDING THAT LATER MOVED TO SEVERE. THE PATIENT WAS PACK WITH GAUZE AND BALLOON UNSUCCESSFULLY. THE BLEEDING WAS UNILATERAL ON THE RIGHT SIDE. EMBOLIZATION WAS LATER TRIED AT A HOSPITAL UNSUCCESSFULLY. ON (B)(6) 2021 THE PATIENT HAD A SUCCESSFUL LIGATION PROCEDURE. NO FURTHER BLEEDING HAS BEEN NOTED.

  Patient problems: Epistaxis

  MAUDE report 11728036 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO WEEKS POST CLARIFIX PROCEDURE ((B)(6) 2021), THE PATIENT PRESENTED WITH A SEVERE NOSE BLEED ((B)(6) 2021). THE PATIENT WAS PACKED WITH RHINOROCKET AND ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE PATIENT HAD A UNILATERAL BLEED ON THE LEFT SIDE, WAS ON ELIQUIS AND A PRIOR HISTORY OF POLYPS AND SINUS SURGERY. THE NEXT DAY ((B)(6) 2021), THE DOCTOR TOOK THE PATIENT TO THE OR TO CAUTERIZE THE SPHENOPALATINE ARTERY BRANCH ON THE LEFT SIDE. NO FURTHER BLEEDING HAS BEEN REPORTED.

  Patient problems: Epistaxis

  MAUDE report 11728009 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A UNEVENTFUL BILATERAL CLARIFIX PROCEDURE ON (B)(6) 2020. PATIENT BEGAN TO HAVE EPISODIC POSTERIOR NOSE BLEEDS ON (B)(6) 2020. SEEN AT CLINIC ON (B)(6) 2020. ENDOSCOPY SHOWED NO ACTIVE BLEEDING, NORMAL TISSUE CHANGES RELATED TO CRYOTHERAPY. SEEN BY LOCAL ED ON (B)(6) 2020 AND ON (B)(6) 2020 FOR PACKING. PATIENT WENT TO ED THAT NIGHT WITH MORE POSTERIOR BLEEDING. TRANSFERRED TO ANOTHER MEDICAL CENTER AND LEFT SIDE PACKED. ON (B)(6) 2020 VISITED THE OPERATING ROOM. WAS NOTED TO HAVE BILATERAL BRISK BLEEDING FROM THE POSTERIOR END OF THE TREATMENT SITE BILATERALLY. BLEEDING WAS CONTROLLED WITH ENDOSCOPIC MONOPOLAR CAUTERY BILATERALLY. SHE WAS KEPT OVERNIGHT (B)(6) FOR OBSERVATION FOR ADDITIONAL BLEEDING AND WAS DISCHARGED THE AM OF (B)(6). SHE HAS RECOVERED WITHOUT SEQUELAE OR OTHER COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 10391136 ↗