ReliaCatchRecalls & reported problems across all models
Covidien LP · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 70
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of ReliaCatch by Covidien LP in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2017 and Dec 30, 2024 — classified as 1 death, 1 injury, 67 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (48 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
Reports received per month, all models
Most reported ReliaCatch problems
Device problems
- Material Split, Cut or Torn48
- Torn Material14
- Detachment of Device or Device Component4
- Break3
- Detachment Of Device Component3
- Insufficient Device Problem Information3
- Material Separation3
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient19
- No Consequences Or Impact To Patient16
- Insufficient Information6
- Laceration(s)2
- Tissue Damage2
- Unspecified Tissue Injury2
- Abdominal Distention1
ReliaCatch models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ReliaCatch CATCH10Laparoscope, general & plastic surgery59 reports
- ReliaCatch CATCH12Laparoscope, general & plastic surgery1 death11 reports
Recent ReliaCatch adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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