Alexis Wound Protector-Retractor C8313Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915125219), received between Jun 21, 2024 and Feb 27, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: PYELOPLASTY. EVENT DESCRIPTION: "HOSPITAL [NAME]. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH A HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. THE LOT NUMBER IS EITHER 1558883 OR 1549879" INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW PRODUCT AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471822 ↗
• MalfunctionJun 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: FORMATION OF DEFUNCTIONING LOOP COLOSTOMY. DESCRIPTION OF EVENT: "WE HAD AN INCIDENT LAST WEEK WHEREBY ONE OF THE XXS ALEXIS RETRACTORS BROKE. HERE IS A BRIEF DESCRIPTION OF EVENT: "PATIENT WAS IN THEATRE FOR FORMATION OF DEFUNCTIONING LOOP COLOSTOMY, ALEXIS WOUND RETRACTOR XXS WAS REQUESTED BY SURGEON. ALEXIS WAS INSERTED INTO ABDOMINAL OPENING, WHILE TURNING DOWN EXTERNAL LOOP THE CONNECTING SHEATH SPLIT VERTICALLY BETWEEN THE RINGS." ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 05JUN2024: THE EVENT DATE INITIALLY REPORTED WAS INCORRECT AND THE INCIDENT OCCURRED ON 07-05-2024, I WAS NOTIFIED ON (B)(6) 2024. THE LOT NUMBER IS 1502196. THE DEVICE HAS BEEN DISPOSED OF, BUT A PICTURE OF THE DEVICE WAS TAKEN. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 13AUG2024: ALEXIS SPLIT WHEN FOLDING IT DOWN BEFORE PLANNING TO BRING A LOOP OF BOWEL OUT TO FORM STOMA. REPORTED INCIDENT TO THE APPROPRIATE PERSONS, HANDED FAULTY/DAMAGED ITEM OFF THE STERILE FIELD. NO PARTICULATION WAS NOTICED. INTERVENTION: UNKNOWN. PATIENT STATUS: PATIENT IS WELL.

  Patient problems: Insufficient Information

  MAUDE report 19589665 ↗