ReliaCatch CATCH10Recalls & reported problems
Covidien LP · Specimen Retrieval Bag · Class 2
Quick summary
This Covidien ReliaCatch CATCH10 is a specimen retrieval bag, used to pull tissue such as a gallbladder out through a small incision during laparoscopic surgery. The 59 reports mostly describe the bag splitting, tearing or rip along its seam while the specimen was being removed, and sometimes coming apart from its metal band so it would not open. There are no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10884521704046), received between Jun 27, 2017 and Dec 30, 2024 — classified as 1 injury, 57 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (42 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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn42
- Torn Material12
- Insufficient Device Problem Information3
- Material Separation3
- Break2
- Detachment Of Device Component2
- Detachment of Device or Device Component2
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient16
- No Consequences Or Impact To Patient9
- Insufficient Information6
- Laceration(s)1
- No Information1
- Tissue Damage1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SPECIMEN RETRIEVAL BAG BROKE AS THE GALLBLADDER WAS BEING PULLED THROUGH THE PORT. THE BAG RIPPED ALONG THE SEAM. A NEW BAG WAS USED TO REMOVE THE SPECIMEN AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21035843 ↗MalfunctionNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE SPECIMEN BAG RIPPED.
Patient problems: Insufficient Information
MAUDE report 20789876 ↗MalfunctionMar 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN REMOVING THE SPECIMEN, THE BAG TORE. ANOTHER DEVICE FORM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18945289 ↗MalfunctionSep 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BAG RUPTURED DURING SPECIMEN REMOVAL.
Patient problems: Insufficient Information
MAUDE report 17766951 ↗MalfunctionAug 23, 2023Material Separation; Material Separation
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON PUT THE BAG THROUGH THE TROCAR AND OPEN IT, THE BAG WAS ALREADY DETACHED FROM THE METAL BAND AND COULDN'T OPEN. A NEW BAG WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17607675 ↗MalfunctionMay 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE RETRIEVAL BAG BROKE WHILE INSIDE PATIENT'S ABDOMEN AS THE SURGEON WAS TRYING TO REMOVE PIECES OF THE GALLBLADDER. ALL PIECES WERE ACCOUNTED FOR AND REMOVED WITHOUT FURTHER INCIDENCE.
Patient problems: Insufficient Information
MAUDE report 16873604 ↗MalfunctionApr 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, RETRIEVAL OF THE SPECIMEN, THE THREE BAGS TORE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824825 ↗MalfunctionApr 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, RETRIEVAL OF THE SPECIMEN, THE THREE BAGS TORE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824749 ↗MalfunctionApr 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, RETRIEVAL OF THE SPECIMEN, THE SIX BAG TORE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824707 ↗MalfunctionApr 27, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, RETRIEVAL OF THE SPECIMEN, THE SIX BAG TORE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824673 ↗MalfunctionApr 27, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, RETRIEVAL OF THE SPECIMEN, THE SIX BAG TORE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824581 ↗MalfunctionApr 27, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, RETRIEVAL OF THE SPECIMEN, THE THREE BAGS TORE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824495 ↗MalfunctionMar 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE ON SPECIMEN REMOVAL, THE BAG WAS TORN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16601554 ↗InjuryJan 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE PULLING BAG THROUGH 11MM TROCAR PORT INCISION, THE RETRIEVAL BAG BROKE OPEN AT SEAM, SPILLING GALL BLADDER AND GALLSTONES. A BIGGER INCISION HAD TO BE MADE TO GET GALL BLADDER AND GALLSTONES OUT OF THE SUBCUTANEOUS TISSUE. THE EVENT LED TO LACERATIONS.
Patient problems: Laceration(s); Unspecified Tissue Injury
MAUDE report 16246812 ↗MalfunctionSep 22, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCTECTOMY, WHILE RETRIEVING THE SPECIMEN AT THE TROCAR INCISION, THE BAG TORE AT THE SEAM, AND SPECIMEN FELL INTO THE PATIENT. THE TROCAR INCISION WAS EXTENDED FROM 8 MM TO 12MM FOR REMOVAL, AND THE SPECIMEN WAS RETRIEVED WITHOUT THE BAG TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15464737 ↗MalfunctionJun 21, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE SPECIMEN RETRIEVAL BAG BURST.
Patient problems: Insufficient Information
MAUDE report 14756517 ↗MalfunctionSep 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BAG RIPPED. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12435166 ↗MalfunctionJul 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING ROBOTIC-ASSISTED LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG TORE AT THE BOTTOM SEAM WHILE REMOVING THE GALL BLADDER WITH LARGE GALL STONE. THE BAG WAS REMOVED AND THE SPECIMEN WAS REMOVED MANUALLY WITHOUT A BAG. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12140196 ↗MalfunctionJun 8, 2021Material Separation; Material Separation
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CYSTECTOMY, THE BAG PARTIALLY DETACHED FROM THE RING. THE DEVICE COULD NOT BE RETRACTED INTO THE SHAFT AND THIS AFFECTED THE SUCCESSFUL INSERTION INTO TROCAR. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES BUT THERE WAS NO ADVERSE REACTION. A NEW BAG WAS USED WHICH WORKED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11961919 ↗MalfunctionMay 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG TORE DURING REMOVAL OF THE SPECIMEN. THE SPECIMEN WAS REMOVED WITH THE SAME DEVICE THAT TORE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11869676 ↗MalfunctionMay 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, DURING SPECIMEN REMOVAL, THE BAG TORE. THE SPECIMEN WAS REMOVED WITH THE RIPPED BAG. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11869653 ↗MalfunctionMay 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE RETRIEVING THE SPECIMEN, THE BAG TORE. THE SPECIMEN FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO RETRIEVE THE SPECIMEN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11761298 ↗MalfunctionApr 29, 2021Break; Break
ACCORDING TO THE REPORTER, AT COMPLETION OF ROBOTIC LOBECTOMY, SPECIMEN (LOBE) WAS PLACED IN BAG AND DURING REMOVAL OF BAG AND SPECIMEN FROM THE CHEST, THE BAG TORE. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 11746762 ↗MalfunctionApr 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE BAG OF THE SPECIMEN POUCH SPLIT AT THE BOTTOM DURING ROBOTIC-ASSISTED LAPAROSCOPIC PROSTATECTOMY. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11735988 ↗MalfunctionApr 27, 2021Material Split, Cut or Torn
RELIA CATCH 10 BAG RIPPED, NO HARM TO PATIENT, SURGEON USED ANOTHER. FDA SAFETY REPORT ID # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11737185 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.