Alexis Wound Protector-RetractorRecalls & reported problems across all models

We found 7 models of Alexis Wound Protector-Retractor by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2016 and Feb 27, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Alexis Wound Protector-Retractor problems

Alexis Wound Protector-Retractor models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alexis Wound Protector-Retractor C8301

  Ring (Wound Protector), Drape Retention, Internal
  14 reports
• Alexis Wound Protector-Retractor C8312

  Ring (Wound Protector), Drape Retention, Internal
  7 reports
• Alexis Wound Protector-Retractor C8323

  Ring (Wound Protector), Drape Retention, Internal
  6 reports
• Alexis Wound Protector-Retractor C8322

  Ring (Wound Protector), Drape Retention, Internal
  5 reports
• Alexis Wound Protector-Retractor C8302

  Ring (Wound Protector), Drape Retention, Internal
  3 reports
• Alexis Wound Protector-Retractor C8313

  Ring (Wound Protector), Drape Retention, Internal
  2 reports
• Alexis Wound Protector-Retractor C8303

  Ring (Wound Protector), Drape Retention, Internal
  1 report

Recent Alexis Wound Protector-Retractor adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPIC MYOMECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4), COMPLAINT 2 OF 2: (B)(4). DURING THE SURGERY, A GAS LEAKAGE ISSUE WAS NOTICED AFTER A PERIOD OF OPERATION. WHEN THE USER REMOVED THE C8312 FOR INSPECTION, IT WAS FOUND THAT THE GREEN RING HAD PARTIALLY DETACHED FROM THE WOUND SHEATH. AFTER REPLACING IT WITH A NEW ONE, THE SAME ISSUE OCCURRED AGAIN AFTER SOME TIME. USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20 JAN 2025 VIA EMAIL: THE MALFUNCTION OCCURRED MID-PROCEDURE. IT WAS OBSERVED THAT THE PATIENT'S ABDOMINAL INSUFFLATION HAD DECREASED, LEADING TO THE SUSPICION OF A POTENTIAL AIR LEAKAGE. UPON INVESTIGATION, IT WAS IDENTIFIED THAT THE LEAKAGE ORIGINATED FROM C8312. THE ISSUE WAS CONFIRMED WHEN C8312 WAS REMOVED FROM THE PATIENT, REVEALING THE PROBLEM. THE SHEATH BECAME DETACHED AT THE CONNECTION POINT WITHIN THE GREEN RING. NO INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING PLACEMENT. NO INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING THE PROCEDURE. THE DEVICE DID NOT PARTICULATE. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: THE PATIENT IS IN GOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377168 ↗
• MalfunctionFeb 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPIC MYOMECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4), COMPLAINT 2 OF 2: (B)(4). DURING THE SURGERY, A GAS LEAKAGE ISSUE WAS NOTICED AFTER A PERIOD OF OPERATION. WHEN THE USER REMOVED THE C8312 FOR INSPECTION, IT WAS FOUND THAT THE GREEN RING HAD PARTIALLY DETACHED FROM THE WOUND SHEATH. AFTER REPLACING IT WITH A NEW ONE, THE SAME ISSUE OCCURRED AGAIN AFTER SOME TIME. USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20 JAN 2025 VIA EMAIL: THE MALFUNCTION OCCURRED MID-PROCEDURE. IT WAS OBSERVED THAT THE PATIENT'S ABDOMINAL INSUFFLATION HAD DECREASED, LEADING TO THE SUSPICION OF A POTENTIAL AIR LEAKAGE. UPON INVESTIGATION, IT WAS IDENTIFIED THAT THE LEAKAGE ORIGINATED FROM C8312. THE ISSUE WAS CONFIRMED WHEN C8312 WAS REMOVED FROM THE PATIENT, REVEALING THE PROBLEM. THE SHEATH BECAME DETACHED AT THE CONNECTION POINT WITHIN THE GREEN RING. NO INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING PLACEMENT. NO INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING THE PROCEDURE. THE DEVICE DID NOT PARTICULATE. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: THE PATIENT IS IN GOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376855 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 23, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED. NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [NAME] INCOMING INSPECTION (B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. THERE IS A ITEM REQUIRE CER IN THIS REPORT. PARTICULATE: HAIR, BUG - C8303 LOT# 1424309 (1 EA). ADDITIONAL INFORMATION RECEIVED VIA EMAIL 01NOV2021 FROM [NAME] REGULATORY AFFAIRS AND QUALITY ASSURANCE: IT WAS REPORTED THAT THERE WAS ONLY ONE BUG FOUND. NO REPORT OF HAIR IN PACKAGING. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865965 ↗
• 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 ↗
• 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 ↗

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