ChitoZolve CNS155Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821925044166), received between Jul 27, 2023 and Oct 4, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT A PATIENT DEVELOPED AN INFECTION AFTER A SEPTUM CORRECTION IN COMBINATION WITH USE OF CHITOSOLVE NASAL SPLINT. THE LOCATION WAS REPORTEDLY VERY SENSITIVE FOR GETTING AN INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION WAS RESOLVED. THE DOCTOR DID NOT INVESTIGATE THE INFECTION AND NO CULTURES WERE DONE. THE PATIENT'S CURRENT CONDITION IS GOOD. THERE WAS NO ALLEGATION OF ANY DEVICE MALFUNCTION. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 17872158 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED INFORMATION FROM A POST-MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY THAT THE CHITOZOLVE FINISHED GOOD (8/PK) WAS USED AND SOFT TISSUE TRAUMA, GRANULATION, AND EDEMA ALL OCCURRED AND WERE POSSIBLY DEVICE RELATED. MODERATE AND HARD TO DETACH ADHESIONS ALSO FORMED IN THE NASAL CAVITY REQUIRING BLUNT DISSECTION, HOWEVER THESE ADHESIONS WERE DUE TO PATIENT FACTORS AND UNRELATED TO THE DEVICE. THIS LEAD TO FURTHER MANAGEMENT OF THE PATIENT FOLLOWING SURGERY. THE INTENDED PROCEDURE WAS THERAPEUTIC AND WAS COMPLETED WITH THE SAME DEVICE. NO OTHER DEVICES WERE INVOLVED IN THE EVENT. THE CHITOZOLVE SPLINT ADEQUATELY SEPARATED TISSUE COMPROMISED BY THE SURGICAL TRAUMA. THE DEVICE HELPED CONTROL MINIMAL BLEEDING FOLLOWING SURGERY/TRAUMA AND HELPED IN NATURAL WOUND HEALING. THE DEVICE WAS DISSOLVED COMPLETELY AT THE TIME OF 20-DAY FOLLOW-UP.

  Patient problems: Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17653473 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A POST MARKET CLINICAL FOLLOW-UP SURVEY WAS COMPLETED BY AN UNIDENTIFIED CUSTOMER IN WHICH A PATIENT WAS BEING MANAGED POSTOPERATIVELY USING THE CHITOZOLVE INTRANASAL SPLINT. THIS WAS BEING USED TO FOR AFTER NASAL SURGERY TO SEPARATE TISSUE/STRUCTURES COMPROMISED BY THE SURGICAL TRAUMA, HELP CONTROL MINIMAL BLEEDING FOLLOWING SURGERY, AND SEPARATE AND PREVENT ADHESIONS BETWEEN MUCOSAL SURFACES DURING MESOTHELIAL CELL REGENERATION IN THE NASAL CAVITY. THE SPLINT WAS UNABLE TO STOP THE MINIMAL BLEEDING POSTOPERATIVELY AFTER HAVING TECHNICAL ISSUES. IT WAS CLARIFIED THAT THE TECHNICAL ISSUES WERE DUE TO THE SPLINT BEING HYDRATED WITH PHARMACEUTICAL AGENTS. A NASAL CAUTERY HAD TO BE USED TO PREVENT FURTHER BLOOD LOSS. IT WAS STATED THAT THE TREATMENT DID PREVENT NASAL CAVITY ADHESIONS AND IT ALSO AIDED IN NATURAL WOUND HEALING IN THIS PATIENT. THERE WAS NO ADDITIONAL NOTATION OF IMPACT TO THE PATIENT OR TREATMENT REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17652669 ↗
• InjuryAug 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  OLYMPUS RECEIVED INFORMATION FROM A POST-MARKET CLINICAL FOLLOW-UP SURVEY THAT THE CHITOZOLVE FINISHED GOOD (8/PK) WAS USED FOR A THERAPEUTIC PROCEDURE AND PROLONGED BLEEDING OCCURRED WHICH REQUIRED MANAGEMENT OF THE PATIENT WITH POST-SURGICAL EPISTAXIS. THE CHITOZOLVE SPLINT DID NOT STOP BLEEDING UPON INSERTION INTO THE PATIENT DUE TO TECHNICAL ISSUES AND DID NOT REMAIN WHERE IT WAS PLACED. THE DEVICE WAS BEING USED AS A NASAL HEMOSTAT TO TREAT EPISTAXIS AND THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO OTHER DEVICES INVOLVED IN THE EVENT OR REPLACED DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17643613 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A POST MARKET CLINICAL FOLLOW-UP SURVEY WAS COMPLETED BY AN UNIDENTIFIED CUSTOMER IN WHICH A PATIENT WAS BEING TREATED FOR EPISTAXIS USING THE CHITOZOLVE INTRANASAL SPLINT FOR HEMOSTATIC PURPOSES IN (B)(6) 2023. THE CUSTOMER STATED THE PATIENT SUFFERED SOFT TISSUE TRAUMA, EDEMA, AND GRANULATION POSSIBLY AS A RESULT OF USING THIS DEVICE AND REQUIRED ADDITIONAL MEDICATIONS. THE PATIENT MADE A FULL RECOVERY.

  Patient problems: Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17642507 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OLYMPUS EMPLOYEE REPORTED THAT FOLLOWING A THERAPEUTIC PROCEDURE IN THE MANAGEMENT OF A PATIENT WITH POST-SURGICAL EPISTAXIS WITH CHITOZOLVE DEVICE THE MALE PATIENT (AGE BETWEEN 18-34 YEARS) SUFFERED CONTINUOUS POSTOPERATIVE HEMORRHAGE UPON INSERTION IN PATIENT WITH EPISTAXIS. THE DEVICE WAS HYDRATED WITH PHARMACEUTICAL AGENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER BUT UNAVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17627645 ↗
• InjuryAug 24, 2023Melted; Device Dislodged or Dislocated; Melted; Device Dislodged or Dislocated

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PATIENT DEVELOPED EDEMA AND GRANULATION POSSIBLY RELATED TO THE CHITOZOLVE FINISHED GOOD (8/PK) INTRANASAL SPLINT. THESE WERE NOTED DURING MANAGEMENT OF THE PATIENT FOLLOWING AN UNSPECIFIED SURGERY. THE DEVICE WAS USED THERAPEUTICALLY TO SEPARATE TISSUE OR STRUCTURES COMPROMISED BY SURGICAL TRAUMA, TO HELP CONTROL MINIMAL BLEEDING FOLLOWING SURGERY OR TRAUMA, AND TO SEPARATE AND PREVENT ADHESIONS BETWEEN MUCOSAL SURFACES DURING MESOTHELIAL CELL REGENERATION IN THE NASAL CAVITY. HOWEVER, THE DEVICE REPORTEDLY DID NOT ADEQUATELY SEPARATE THE TISSUES COMPROMISED BY SURGICAL TRAUMA AND DID NOT AID IN NATURAL WOUND HEALING DUE TO UNCLEAR REASONS. IT ALSO DID NOT PREVENT ADHESIONS IN THE NASAL CAVITY AS THE DEVICE DISSOLVED TOO FAST AND DID NOT REMAIN WHERE PLACED. THE PATIENT HAD A THIRD-PARTY NASAL PACKING PLACED AND ALSO UNDERWENT SHARP DISSECTION OF THE ADHESIONS. THERE WAS NO FURTHER PATIENT IMPACT REPORTED.

  Patient problems: Adhesion(s); Swelling/ Edema

  MAUDE report 17611778 ↗
• InjuryJul 27, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT A PATIENT DEVELOPED "INFECTION, POST-IMPLANTATION INFECTION", AND EDEMA AFTER USING THE CHITOZOLVE NASAL SPLINT FOR A THERAPEUTIC UNSPECIFIED PROCEDURE. THE PROCEDURE WAS REPORTEDLY DONE TO "SEPARATE TISSUE OR STRUCTURES COMPROMISED BY SURGICAL TRAUMA, HELP CONTROL MINIMAL BLEEDING FOLLOWING SURGERY OR TRAUMA, AND TO SEPARATE AND PREVENT ADHESIONS BETWEEN MUCOSAL SURFACES DURING MESOTHELIAL CELL REGENERATION IN THE NASAL CAVITY." ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION WAS OBTAINED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 17410430 ↗