Endo Catch II 173049Recalls & reported problems

Summary

The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 10884523000948), received between Jul 13, 2016 and Aug 10, 2026 — classified as 12 injuries, 193 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (101 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 25 most recent of 205 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  According to the reporter, during a laparoscopic sleeve gastrectomy, during specimen retrieval when was bag was deployed. a piece of plastic bag detached and was left behind in patient. The surgeon was able to retrieved the plastic with a grasper. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191542 ↗
• MalfunctionMar 30, 2026Material Separation

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SPLENECTOMY, DURING SPECIMEN RETRIEVAL, THE BAG RING PARTIALLY DETACHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722445 ↗
• MalfunctionJan 6, 2026Material Separation

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC NEPHRECTOMY, WHEN THE PLUNGER WAS PUSHED OUT, ONE SIDE OF THE FLEXIBLE RING WAS IN A DETACHED STATE, BUT SINCE IT COULD STILL BE USED, IT WAS USED AS IS. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976140 ↗
• MalfunctionJan 6, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC LOBECTOMY, THE BAG TORE AND THE SPECIMEN FELL INTO THE PATIENT. THE SPECIMEN WAS RETRIEVED USING A NEW DEVICE, WHICH WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975792 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE LAPAROSCOPIC PROCEDURE FOR THE REMOVAL OF A LARGE CYST WITH SIGNIFICANT FLUID CONTENT, THREE BAGS WERE EACH FOUND TO BE BROKEN WHEN ENTERED THROUGH A 15MM PORT, AND THE BAG WAS PARTIALLY DETACHED FROM THE RING. THE DEVICE WAS BEING APPLIED WHEN MOVING THE CYST OUT FROM THE ABDOMEN. DESPITE THE BREAKAGE OF ALL THREE BAGS, THE SURGICAL TEAM SUCCEEDED IN USING THE LAST BROKEN BAG TO REMOVE THE CYST FROM THE BODY AND NO SPECIMEN FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732917 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE LAPAROSCOPIC PROCEDURE FOR THE REMOVAL OF A LARGE CYST WITH SIGNIFICANT FLUID CONTENT, THREE BAGS WERE EACH FOUND TO BE BROKEN WHEN ENTERED THROUGH A 15MM PORT, AND THE BAG WAS PARTIALLY DETACHED FROM THE RING. THE DEVICE WAS BEING APPLIED WHEN MOVING THE CYST OUT FROM THE ABDOMEN. DESPITE THE BREAKAGE OF ALL THREE BAGS, THE SURGICAL TEAM SUCCEEDED IN USING THE LAST BROKEN BAG TO REMOVE THE CYST FROM THE BODY AND NO SPECIMEN FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732914 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE LAPAROSCOPIC PROCEDURE FOR THE REMOVAL OF A LARGE CYST WITH SIGNIFICANT FLUID CONTENT, THREE BAGS WERE EACH FOUND TO BE BROKEN WHEN ENTERED THROUGH A 15MM PORT, AND THE BAG WAS PARTIALLY DETACHED FROM THE RING. THE DEVICE WAS BEING APPLIED WHEN MOVING THE CYST OUT FROM THE ABDOMEN. DESPITE THE BREAKAGE OF ALL THREE BAGS, THE SURGICAL TEAM SUCCEEDED IN USING THE LAST BROKEN BAG TO REMOVE THE CYST FROM THE BODY AND NO SPECIMEN FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732723 ↗
• MalfunctionNov 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) LOBECTOMY, THE SPECIMEN BAG BROKE.

  Patient problems: Insufficient Information

  MAUDE report 23487899 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ADRENALECTOMY, WHEN REMOVING THE SPECIMEN, THE POUCH WAS OPENED. A TROCAR WAS INSERTED AND THE POUCH WAS EXPANDED, BUT IT WAS TORN FROM THE BEGINNING AND COULD NOT BE USED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304072 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING A LEFT VIDEO-ASSISTED THORACIC SURGERY FOR A LEFT LOWER LOBECTOMY, THE DEVICE RUPTURED WHILE EXTRACTING THE SPECIMEN FROM THE CHEST WALL. UPON REMOVAL, THE SCRUB NURSE OBSERVED A SMALL HOLE AT THE BOTTOM OF THE BAG WHERE A PIECE WAS MISSING. THE SURGICAL TEAM CONDUCTED A THOROUGH SEARCH OF THE CHEST CAVITY AND PERFORMED A 1 L WASH TO CHECK FOR ANY REMAINING FRAGMENTS. THE THORACIC CONSULTANT CONFIRMED THAT NO ADDITIONAL PIECES WERE LEFT INSIDE AND THE MISSING PIECE MATCHED THE HOLE IN THE POUCH. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978582 ↗
• MalfunctionSep 2, 2025Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC NEPHRECTOMY, AFTER INSERTING INTO THE ABDOMINAL CAVITY TO RETRIEVE THE KIDNEY AND PRESSING THE WHITE PLUNGER TO SEAL THE RING, THE RING AND BAG WERE PARTIALLY DETACHED. ANOTHER DEVICE WAS OPENED AND USED, AND THE KIDNEY WAS RETRIEVED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948491 ↗
• MalfunctionAug 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE BAG RUPTURED WHEN RETRIEVING THE SPECIMEN DURING THE OPERATION.

  Patient problems: Insufficient Information

  MAUDE report 22858026 ↗
• MalfunctionAug 20, 2025Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, THE BAG¿S RING PARTIALLY DETACHED AND THE BAG PARTIALLY FELL OUT OF THE RING WHILE ATTEMPTING TO RETRIEVE A SPECIMEN. DESPITE THE DEFECT, THE TISSUE SPECIMEN WAS SUCCESSFULLY REMOVED USING FORCEPS, AND NO PART OF THE SPECIMEN FELL INTO THE PATIENT¿S BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850278 ↗
• MalfunctionJul 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT NEPHRECTOMY FOR A PATIENT WITH A MEDICAL HISTORY OF KIDNEY CANCER/TUMOR, THE POUCH BAG TORE DURING THE REMOVAL OF THE KIDNEY. ANOTHER POUCH WAS USED TO RETRIEVE THE SPECIMEN AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646701 ↗
• MalfunctionJun 30, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE ROBOTIC ASSISTED THORACOSCOPIC LOBECTOMY, THE RIGHT UPPER LOBE SPECIMEN WAS BEING RETRIEVED VIA AN ENLARGED PORT SITE WHEN THE BAG TORE, RESULTING IN PLASTIC SHARDS FROM THE DEVICE COMPONENT FALLING INTO THE THORACIC CAVITY OF THE PATIENT. THE SPECIMEN WAS ALMOST COMPLETELY REMOVED AT THIS STAGE AND WAS RETRIEVED INTACT THROUGH THE PORT. TWO FRAGMENTS OF PLASTIC WERE RETRIEVED FROM THE THORACIC CAVITY. THESE FRAGMENTS WERE SIZE MATCHED WITH THE DEFECT IN THE BAG, AND A THOROUGH INSPECTION OF THE THORACIC CAVITY WAS PERFORMED WITH NO FURTHER FRAGMENTS IDENTIFIED. THE INCISION WAS EXTENDED DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22355192 ↗
• MalfunctionMay 30, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC PROSTATECTOMY SURGERY, WHEN PLACING THE SPECIMEN PIECE IN THE SPECIMEN BAG, PART OF THE BAG'S PLASTIC FIXED TO THE CHROME CAME LOOSE IN THE PATIENT'S CAVITY. THE SPECIMEN FELL INTO THE CAVITY AND WAS RETRIEVED. THE SURGEON FOUND PART OF THE PLASTIC THAT HAD COME LOOSE IN THE CAVITY AFTER THE FINAL REVIEW OF THE SURGERY AND REMOVED IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117937 ↗
• MalfunctionMay 14, 2025Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A VIDEO LAPAROSCOPIC HEPATECTOMY, THE POUCH WAS PARTIALLY TORN WHEN OPENED IN THE PATIENT'S CAVITY, AND THE BAG PARTIALLY DETACHED FROM THE RING. DESPITE THIS, THE DOCTOR MANAGED TO CLOSE THE BAG AND REMOVE THE CONTENTS WITHOUT ANY MAJOR PROBLEMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017775 ↗
• InjuryMay 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN OOPHORECTOMY BY VIDEOLAPAROSCOPY USING THE POUCH, PART OF THE SAC WAS LOOSE FROM THE RING, WHICH HINDERED THE PROCESS OF REMOVING THE PIECE. THE INCISION WAS EXTENDED MORE THAN 1 INCH (2.54CM) DUE TO THE PRODUCT PROBLEM, AS THE BAG PARTIALLY DETACHED FROM THE RING. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THE DOCTOR DECIDED TO OPEN THE INCISION TO MANUALLY REMOVE THE PIECE.

  Patient problems: Laceration(s)

  MAUDE report 22015465 ↗
• MalfunctionApr 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROBOTIC PROCEDURE, THE RETRIEVAL BAG BEGAN TO TEAR DURING ADVANCEMENT AND DISLODGED FROM THE RING PRIOR TO CINCHING, NOT IN THE NORMAL FASHION THAT THE RING CINCHES OFF OF THE DEVICE DURING REMOVAL. TO RESOLVE THE ISSUE, THE SPECIMEN WAS SUCCESSFULLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872751 ↗
• MalfunctionMar 5, 2025Break; Material Separation; Break; Material Separation

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC LIVER RESECTION, AT THE TIME OF EXTRACTION, THE BAG PARTIALLY DETACHED FROM THE RING. THE SURGICAL CABLE BROKE INSIDE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527134 ↗
• MalfunctionJan 17, 2025Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE BAG OF THE DEVICE TORE AND PARTIALLY DETACHED FROM THE RING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182195 ↗
• MalfunctionJan 8, 2025Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE BAG PARTIALLY DETACHED FROM THE RING. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND THE SPECIMEN DID NOT FALL INTO THE PATIENT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102946 ↗
• MalfunctionOct 29, 2024Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BAG TORE AND WAS PARTIALLY DETACHED FROM THE RING. ANOTHER RETRIEVAL BAG WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558984 ↗
• MalfunctionSep 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC HYSTERECTOMY, THE MEDICAL STUDENT WAS EMPLOYING A 15MM RETRIEVAL POUCH TO RETRIEVE A LARGE UTERINE SPECIMEN. THE DOCTOR WAS ATTEMPTING TO CLOSE THE BAG AND REMOVE THE THE SPECIMEN FROM THE VAGINA, THEN THE CLOSURE STRING SNAPPED. PIECES OR PARTS FELL INTO THE CAVITY OF THE PATIENT BUT ALL WERE FULLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190404 ↗
• MalfunctionSep 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLORECTAL LOW ANTERIOR RESECTION (LAR), ON THE FINAL PART OF THE SPECIMEN REMOVAL, THE BAG TORE WHILE TRYING TO BAG THE SPECIMEN. A NEW DEVICE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152736 ↗