Alexis Wound Protector-Retractor C8323Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915132941), received between Oct 2, 2020 and Nov 18, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: UNKNOWN. DETAILED DESCRIPTION OF EVENT: [NAME] HOSPITAL. THIS IS A COMPLAINT FROM THE MARKET. REPORT FROM THE SALES REP. THERE WAS A FOREIGN MATTER IN THE POUCH. THIS UNIT WILL BE RETURNED. PRODUCT AVAILABLE FOR RETURN: 1 UNIT. TYPE OF INTERVENTION: REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED. PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585865 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: VATS. DESCRIPTION OF EVENT: COMPLAINT 1 OF 3: (B)(4). MODEL C8401 LOT 1506767 1EA. COMPLAINT 2 OF 3: (B)(4). MODEL C8323 LOT 1524616 1EA - MFR 2027111-2024-00831. COMPLAINT 3 OF 3: (B)(4). MODEL UNKNOWN LOT UNKNOWN 1EA - MFR 2027111-2024-00832. [HOSPITAL] 3 ALEXIS DEVICE MALFUNCTIONS OCCURRED DURING THE SAME PROCEDURE. THE FIRST ALEXIS' SHEATH TORE AS SOON AS THEY PLACED THE DEVICE AND FOLDED THE RING. HALF OF THE SHEATH FELL OFF THE RING ENTIRELY. A SECOND ALEXIS WAS OPENED, HOWEVER THIS DEVICE'S SHEATH TORE NEAR THE ATTACHMENT TO THE RING. A THIRD ALEXIS WAS OPENED, HOWEVER THIS DEVICE'S SHEATH ENTIRELY DISCONNECTED FROM THE RING AS THEY MOVED THE SPECIMEN THROUGH IT. A FOURTH ALEXIS WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THE REP WAS NOT PRESENT AT THE CASE. THERE ARE NO PHOTOS AVAILABLE OF THE DEVICES. THE PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 26AUG2024: IT IS UNKNOWN WHAT INSTRUMENTS WERE BEING USED WITHIN THE ALEXIS. ACCORDING TO THE SCRUB PERSON, THE SHEATH TORE ON THE WHITE RING FOR THE ALEXIS O AND TORE ON THE SIDE FOR THE ALEXIS XXS. ALEXIS O, SIZE S, LOT #

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263279 ↗
• MalfunctionJun 12, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED VAT LEFT UPPER LOBECTOMY EVENT DESCRIPTION: [FACILITY] HOSPITAL THIS IS A COMPLAINT FROM THE MARKET. REPORT FROM THE SALES REP; FORCEPS, SUCTION TUBES, SUTURES, AND ELECTROCAUTERY WERE INSERTED AND REMOVED POSTOPERATIVELY, AND THE SHEATH WAS TORN. IT IS UNKNOWN IF ANY DEBRIS REMAINS IN THE BODY CAVITY. SURGERY TIME IS 3 HOURS, AS USUAL. THE DAMAGE WAS CONFIRMED AFTER THE SURGERY WAS COMPLETED. THE EVENT UNIT WILL BE RETUREND TO AMR FOR FURTHER EVALUATION. INTERVENTION: NI PATIENT STATUS: UNKNOWN // THE PART OF SEATH CAN BE REMAINED IN THE PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114143 ↗
• MalfunctionAug 10, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [FACILITY] INCOMING INSPECTION PO# (B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. THERE ARE THE ITEMS REQUIRE CER IN THIS REPORT. C8323 LOT #1447635 - PARTICULATE: SUSPECTED HAIR (1 EA.). PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204579 ↗
• MalfunctionMay 9, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT [FACILITY] INSPECTION PO# (B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. THERE ARE ITEMS REQUIRE CER IN THIS REPORT. C8323 LOT #1432996 - PARTICULATE: HAIR(1 EA.) PATIENT STATUS: (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338640 ↗
• MalfunctionOct 2, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [NAME] PO#(B)(4). REGARDING TO PO#(B)(4), WE WOULD LIKE TO REPORT THAT THE PRODUCTS DID NOT PASS OUR INSPECTION AS ATTACHED. TORN PACKAGING - C8323, LOT# 1384885 (2 EA). ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14SEP2020 FROM [NAME]: THE PRODUCT DID NOT PASS THE INCOMING INSPECTION OF PO#(B)(4) BECAUSE OF TORN PACKAGING. DETAILS ARE SHOWN ON THE ATTACHED FILE. PATIENT STATUS: NA. TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 10623837 ↗