Alexis Wound Protector-Retractor C8301Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607915117207), received between Sep 14, 2016 and Jul 10, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025No Apparent Adverse Event; Material Split, Cut or Torn; No Apparent Adverse Event; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LOBECTOMY. EVENT DESCRIPTION: TOWARD THE END OF THE PROCEDURE, WHEN THE SURGICAL TEAM REMOVED THE WOUND PROTECTOR TO RETRIEVE THE SPECIMEN, A TEAR WAS OBSERVED BETWEEN THE WHITE RING AND THE WOUND SHEATH. ADDITIONAL INFORMATION OBTAINED FROM DISTRIBUTOR VIA EMAIL ON 11JUN2025: NO INSTRUMENTS USED WITHIN THE ALEXIS DURING PLACEMENT. GRASPER AND SCOPE WERE USED DURING THE PROCEDURE. THE DEVICE DID NOT PARTICULATE, AND PARTICULATE DID NOT FALL INTO THE PATIENT. INTERVENTION: USER REPLACE WITH A NEW ONE. PATIENT STATUS: THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475734 ↗
• MalfunctionJan 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: LAR. DETAILED DESCRIPTION OF EVENT: HOSPITAL: [NAME] HOSPITAL. DISTRIBUTOR: [DISTRIBUTOR'S NAME]. EVENT DATE: 24DEC2024. MODEL #: C8301. LOT #: 1531392. BEFORE THE SURGERY, THE SCRUB NURSE NOTICED A SHORT HAIR INSIDE THE PRODUCT PACKAGING IMMEDIATELY AFTER OPENING IT. AS A RESULT, THE PRODUCT WAS NOT USED AND WAS RETURNED. USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. TYPE OF INTERVENTION: NA (BEFORE USE). PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074510 ↗
• MalfunctionFeb 25, 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)(6). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. THERE ARE ITEMS REQUIRE CER IN THIS REPORT. WE FOUND THE FOREIGN OBJECT LOOKS LIKE HUMAN HAIR. PLEASE CONFIRM THE PHOTO AND LET ME KNOW YOUR INVESTIGATION RESULT. C8301 LOT #1434437 - PARTICULATE: HAIR(1). PATIENT STATUS: NA. NO PATIENT INVOLVEMENT. TYPE OF INTERVENTION: NA. INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13603470 ↗
• MalfunctionMay 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE PERFORMED: THA HOSPITAL: [NAME ] "WHEN ALEXIS WAS USED ON THE LEFT THA AND [NAME ] REMOVED ALEXIS AFTER THA TREATMENT, THE SLEEVE TEAR AND THE OUTER RING AND INNER RING WERE SEPARATED. AFTER THAT, THE INNER RING WAS REMOVED USING A TETHER. SURGEON CHECKED IF THERE WERE ANY REMAINING PIECES OF SLEEVE IN THE WOUND, AND THEN THE WOUND WAS CLOSED AND THE SURGERY WAS COMPLETED." PHOTOS OF THE DEVICE HAVE BEEN PROVIDED. NO PRODUCT RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 21APR2021 FROM [NAME]: METAL RETRACTORS, DRILLS, AND BONE CHISELS WERE USED THROUGH THE DEVICE. THE METAL RETRACTORS WAS USED FOR THE EXCLUSION OF MUSCLES AND TISSUES. THE DRILL WAS USED FOR BONE TRIMMING AND IMPLANT CONNECTION. THE BONE CHISEL WAS USED FOR TRIMMING BONES. ALL PIECES OF THE PRODUCT WAS REMOVED. THE PRODUCT WAS DISPOSED OF AFTER THE CASE AS IT WAS CONTAMINATED BY BLOOD. PATIENT STATUS: NO PATIENT INJURY TYPE OF INTERVENTION: DEVICE WAS REMOVED AND PATIENT WAS INSPECTED FOR PIECES OF THE PRODUCT. WOUND WAS THEN CLOSED AND SURGERY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803246 ↗
• MalfunctionMar 20, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: RIGHT HEMICOLECTOMY. DETAILED DESCRIPTION OF EVENT: HOSPITAL: (B)(6) HOSPITAL. THE CLIENT USES THE NEW CONFIGURATION OF C8301 TO TAKE OUT SPECIMEN, AND THEN THE WOUND SHEATH WAS BROKEN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 2MAR2020 FROM PURCHASING REP: THE SHEATH TEAR OCCURRED MID-PROCEDURE, "WHEN THEY PICK UP THE SPECIMEN". THERE WERE NO INSTRUMENTS USED WITHIN THE ALEXIS. THE ALEXIS WAS REMOVED AND REPLACED WITH A NEW DEVICE TO COMPLETE THE CASE. PATIENT STATUS: FINE. TYPE OF INTERVENTION: NI.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861318 ↗
• MalfunctionAug 28, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: UNKNOWN. MEDWATCH FORM #0505160000-2018-8004 RECEIVED VIA MAIL ON (B)(6) 2018. DATE OF THE EVENT WAS (B)(6) 2018. F AS SPECIMEN WAS BEING REMOVED THROUGH DEVICE, THE BAG/DEVICE PARTIALLY RIPPED. PATIENT STATUS: UNKNOWN. TYPE OF INTERVENTION: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825025 ↗
• MalfunctionMar 28, 2018Material Perforation; Material Perforation

  PROCEDURE PERFORMED: "HERNIOTOMY". EVENT DESCRIPTION: "INSERT THE GREEN RING THROUGH THE INCISION. WHEN SURGEON CURLING THE WHITE RING BUT THE WOUND SHEATH WAS BROKEN ON THE GREEN RING. PLEASE CONSULT WITH PHOTOS." TYPE OF INTERVENTION: NA. PATIENT STATUS: "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7379897 ↗
• MalfunctionNov 8, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED - VIDEO ASSISTED THORACIC SURGERY - LOBECTOMY "REMOVING FROM PATIENT ALEXIS RIPPED IN HALF NO HARM TO PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL AT OCTOBER 10, 2017 FROM MATERIAL MANAGEMENT AT (B)(6) HOSPITAL. THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE DEVICE IS WITH RISK MANAGEMENT DEPARTMENT AND WILL BE SECURED AT THE HOSPITAL. THE LOCATION OF THE RIP IS IN THE CENTER OF THE SHEATH. " THE RINGS ARE INTACT". ALL MATERIAL WAS RETRIEVED. PATIENT STATUS - "NO HARM TO PATIENT." TYPE OF INTERVENTION - NA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7010586 ↗
• MalfunctionOct 27, 2017Material Perforation; Material Perforation

  EVENT DESCRIPTION: "THE SHEATH WAS SEPARATED FROM THE RING." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM SALES MANAGER, ON THURSDAY (B)(6) 2017: " THE SHEATH ON THE WHITE RING SIDE WAS SEPARATED FROM THE RING IN PLACES. THE SEPARATED BEFORE USE AFTER UNPACKING. IT WAS NOT INSERTED AFTER NOTICING THIS." TYPE OF INTERVENTION: UNKNOWN PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985676 ↗
• MalfunctionApr 4, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  PROCEDURE PERFORMED NA - "WE HAVE BEEN INFORMED THAT A NURSE FOUND A HOLE ON THE PACKAGE OF ALEXIS (C8301). THE HOLE WAS FOUND ON (B)(6) AND IT SEEMED TO BE MADE BY A CUTTER-KNIFE. IN OUR INSPECTION PROCESS, WE NEVER USE A CUTTER-KNIFE AND KEEP IT AWAY DURING INSPECTION." "SO, JUST IN CASE, I WOULD LIKE TO MAKE SURE IF YOU HAVE ANY PROCESS WHERE YOUR WORKERS USE A CUTTER KNIFE NEAR THE PRODUCTS OR POSSIBILITY THAT THE PRODUCTS CONTACT WITH A CUTTER KNIFE. I'M LOOKING FORWARD TO YOUR PROMPT REPLY." APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION FROM THE SALE DISTRIBUTOR ON MARCH 20,2017: THE PRODUCT WAS BEING STORED IN THE OPERATION THEATER AND THE FACILITY DOES NOT USE A BOX CUTTERS TO OPEN THE OUTER BOX. THERE ARE NOT PICTURES OF THE WHITE BOXES, BROWN BOXES, OR THE STORAGE LOCATION. TYPE OF INTERVENTION - NA. PATIENT STATUS - NA.

  Patient problems: No Patient Involvement

  MAUDE report 6457315 ↗
• MalfunctionMar 9, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED UNKNOWN - "WHEN DR. TRIED TO CLOSE THE WOUND AFTER THE PROCEDURE, A PIECE OF VINYL WAS FOUND. ALSO, THEY FOUND THAT THE PART OF ALEXIS SHEATH USED LOOKED DAMAGED. THE DR. WOULD LIKE TO KNOW THE PIECE OF VINYL IS FROM ALEXIS. THE DOCTOR HAS BEEN USING THE PRODUCT SINCE THE BEGINNING OF THE LAUNCH IN THE MARKET, BUT HE HAS NEVER EXPERIENCED SUCH INCIDENT BEFORE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391431 ↗
• MalfunctionMar 4, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED UNKNOWN - "CLIENT SET THIS DEVICE ON PATIENT BODY AND INVERTS THE FILM. THE FILM WAS BROKEN NEAR GREEN RING." PATIENT STATUS - FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378877 ↗
• MalfunctionDec 29, 2016Material Perforation; Material Perforation

  PROCEDURE PERFORMED UNKNOWN - "ALEXIS WAS TORN DURING USE." PATIENT STATUS: "THERE WAS NO SPECIAL EVENT OR RESULT TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6213600 ↗
• MalfunctionSep 14, 2016Material Perforation; Material Perforation

  PROCEDURE PERFORMED LAR - "THEY INSERT GREEN RING TO PATIENT BODY AND THEN FIND THE SHEATH WAS BROKEN." PATIENT STATUS - FINE. TYPE OF INTERVENTION - NA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5948390 ↗