Alexis® Contained Extraction System GTB14Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915134273), received between Feb 7, 2023 and Dec 3, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: TLH. EVENT DESCRIPTION: HOSPITAL "[NAME]" THIS IS A COMPLAINT FROM THE HOSPITAL; THE EVENT UNIT WAS USED TO RETRIEVE THE UTERUS. AFTER RETRIEVING, IT WAS FOUND THAT THE BAG WAS TORN, AND THE FRAGMENT MIGHT HAVE BEEN LEFT IN THE PATIENT BODY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: KEPT USING THE EVENT UNIT AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707270 ↗
• MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: UNK. EVENT DESCRIPTION: "HOSPITAL [NAME]. THIS IS A COMPLAINT FROM THE HOSPITAL; THE WOUND RETRACTOR WAS TORN BECAUSE A ROBOT ARM WAS CONTACTED WITH. AS IT WAS TORN IN THE BAG SO IT SEEMS THAT ALL FRAGMENTS WERE COLLECTED BUT THE USER ASKED US TO RECONFIRM WHETHER ALL FRAGMENTS WERE COLLECTED. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. AFTER COLLECTING THE FRAGMENTS AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED." ADDITIONAL INFORMATION PROVIDED BY FI PERSONNEL VIA EMAIL ON 29JAN2026: WAS THE RETRACTOR DEPLOYED THROUGH THE ALEXIS CES CONTAINMENT BAG? YES WAS THE GUARD USED DURING THE PROCEDURE? NO INTERVENTION: AFTER COLLECTING THE FRAGMENTS AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707023 ↗
• MalfunctionMay 2, 2025Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  PROCEDURE PERFORMED: RATLH. EVENT DESCRIPTION: THE PORCH TORE FROM THE RING AND HALF OF IT CAME OFF. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED A NEW HOSPITAL INVENTORY GTB14 AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW GTB14 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954342 ↗
• MalfunctionFeb 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED NA (INCOMING INSPECTION) DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO #(B)(4) THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: DECEMBER 22,2022 PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - GTB14 LOT #1466083 (1 EA.) TYPE OF INTERVENTION: NA (INCOMING INSPECTION) PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315486 ↗