ReliaCatch CATCH12Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521704053), received between Dec 6, 2017 and Sep 16, 2020 — classified as 1 death, 10 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathSep 16, 2020Break; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Break; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED LEFT UPPER LOBECTOMY FOR BRONCHOGENIC ADENOCARCINOMA WITH THE ASSISTANCE OF THE INTUITIVE SURGICAL XI ROBOT. A TOTAL OF 4 ROBOTIC PORT SITES WERE CREATED ALONG THE LEFT LATERAL CHEST WALL BETWEEN THE 7TH AND 8TH RIBS. THE SURGEON HAD COMPLETED THE DISSECTION OF THE LEFT UPPER LOBE AND HAD DEPLOYED THE RETRIEVAL BAG. THE SPECIMEN WAS BEING LOADED INTO THE BAG WHEN THE SURGEON NOTED A LARGE AMOUNT OF BLOOD IN THE CAVITY. ANESTHESIOLOGIST NOTED NO BLOOD PRESSURE. THE SURGEON CONVERTED THE PROCEDURE TO OPEN THORACOTOMY, MASSIVE TRANSFUSION PROTOCOL IMPLEMENTED ALONG WITH CARDIOPULMONARY RESUSCITATION (CPR)- ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) PROTOCOL. THE PATIENT NEVER RESPONDED TO ANY OF THE RESUSCITATIVE EFFORTS AND EXPIRED. AFTERWARDS, IT WAS NOTED THAT THE LEFT PULMONARY ARTERY HAD A TEAR IN IT. THE RETRIEVAL BAG WAS INSPECTED, AND IT WAS NOTED THAT THERE WAS A PIECE OF THE RING WIRE PROTRUDING OUT.

  Patient problems: Abdominal Distention; Abrasion; Bone Fracture(s); Bruise/Contusion; Cardiac Arrest; Death; Exsanguination; Hemorrhage/Blood Loss/Bleeding; Hemothorax; Hypovolemic Shock; Laceration(s); Low Blood Pressure/ Hypotension; No Code Available; Perforation; Pulmonary Edema; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10544055 ↗
• MalfunctionSep 11, 2020Detachment 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 VIDEO ASSISTED LEFT THORACOSCOPY WITH LEFT UPPER LOBECTOMY, WHILE PULLING OUT THE DEVICE ON THE PATIENT, THE SPECIMEN BAG RIPPED ALONG THE SEAM. THE SPECIMEN WAS PLACED IN A RETRIEVAL BAG AND WAS ABLE TO BE RETRIEVED BY USING A RIB SPREADER TO GENTLY SPREAD THE RIBS. THE BAG WAS INSPECTED AND ALL THE PARTS WERE ACCOUNTED FOR SURGICAL SITE CHECK TO ENSURE THAT THERE WAS NO RETAINED BAG IN PLACE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10525320 ↗
• MalfunctionDec 25, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOBECTOMY, THE BAG TORE WHEN IT WAS TIME TO RETRIEVE THE CANCEROUS LUNG, WHICH LED TO THE CANCER NODULE BEING IN CONTACT WITH THE PARIETAL WALL. THE SPECIMEN HAD TO BE MANUALLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517805 ↗
• MalfunctionDec 15, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A RIGHT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), THE SPECIMEN WAS PLACED IN A DEVICE'S BAG. WHILE PULLING THE SPECIMEN OUT OF THE CHEST, THE BAG RIPPED OUTSIDE OF THE PATIENT. ALL PIECES WERE ACCOUNTED FOR BY THE SURGEON AND CIRCULATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9471020 ↗
• MalfunctionDec 12, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC SURGERY, IN THE MIDDLE OF INSERTION OF THE RETRIEVAL BAG INTO THE TROCAR TO COLLECT THE RESECTED STOMACH, CREAKING SOUND WAS GENERATED. THE SURGEON FELT STRONG RESISTANCE DESPITE OF THAT THE CATCH WAS ABLE TO BE INSERTED INTO THE ABDOMINAL CAVITY AND THE SPECIMEN COLLECTION WAS PERFORMED. THE BAG TIP WAS CLOSED AND THE TROCAR SLEEVE WAS REMOVED TO THE OUTSIDE OF BODY, AND AN ATTEMPT WAS MADE TO PULL THE SHAFT OF THE CATCH OUT OF THE TROCAR AFTER SPECIMEN COLLECTION ,BUT IT COULD NOT BE PULLED. A NEW TROCAR WAS TAKEN OUT, AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM AFTER CHECKING THE INSIDE OF THE ABDOMINAL CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459999 ↗
• MalfunctionNov 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A FLEXIBLE BRONCHOSCOPY AND LEFT VIDEO ASSISTED THORACIC SURGERY (VATS) WITH LEFT LOWER LOBECTOMY, UPON PULLING THE BAG OUT OF THE PATIENT, THE BAG SPLIT AT THE SEAM OUTSIDE OF THE PATIENT. THE BAG WAS INSPECTED, IT WAS ALL ACCOUNTED FOR TO ENSURE NO PORTION WAS RETAINED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9348162 ↗
• MalfunctionJun 6, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED MEDIASTINAL MASS RESECTION PROCEDURE, WHILE THE SURGEON TRYING TO REMOVE THE SPECIMEN, BOTH BAGS PERFORATED AND SPECIMEN FELL INTO THE CAVITY. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8677142 ↗
• MalfunctionNov 2, 2018Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE THE RETRIEVAL BAG DIDN'T FIT DOWN THE STEP TROCAR EASILY. LUBRICANT WAS USED TO GET THE INSTRUMENT DOWN THE PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8032661 ↗
• MalfunctionSep 21, 2018Detachment 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 ROBOTIC SPLENECTOMY, WHEN PERFORMING REMOVAL OF THE SPLEEN, THE BAG WAS RIPPED WHILE REMOVING THE SPECIMEN AND OVER 30 MINUTES TO SUCTION MORCELLATED SPECIMEN AND OMENTUM. THEY REMOVED THE SPECIMEN AND TISSUE MANUALLY THROUGH PORT DEFECT AND TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898238 ↗
• MalfunctionMar 27, 2018Detachment Of Device Component; Torn Material; Detachment Of Device Component; Torn Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, UPON INITIAL USE AND DEPLOYMENT OF THE BAG, THE DEVICE¿S BAG PARTIALLY DETACHED FROM THE RING. SURGEON DID NOT FOLLOW THE PROPER STEPS TO DEPLOY THE BAG. THEY USED THE BAG AND TOOK OUT THE SPECIMEN. SURGEON FELT THE RIM OF THE BAG TORE BUT IT WAS BECAUSE ALL OF THE STEPS WERE NOT FOLLOWED PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7374865 ↗
• MalfunctionDec 6, 2017Torn Material; Torn Material

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC REMOVAL OF PELVIC MASS. THE SURGEON WAS TRYING TO REMOVE THE SPECIMEN AND THE BAG TORE. ANOTHER BAG WAS PULLED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088970 ↗