ENDOPATH BASXRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 72
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of ENDOPATH BASX by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2017 and Apr 6, 2026 — classified as 3 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Crack” (23 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 ENDOPATH BASX problems
Device problems
- Crack23
- Material Integrity Problem15
- Break12
- Delivered as Unsterile Product12
- Component or Accessory Incompatibility10
- Tear, Rip or Hole in Device Packaging6
- Manufacturing, Packaging or Shipping Problem3
- Packaging Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient22
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
ENDOPATH BASX models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOPATH BASX TB12LTLaparoscope, general & plastic surgery35 reports
- ENDOPATH BASX TB5LTLaparoscope, general & plastic surgery24 reports
- ENDOPATH BASX CTB12LTLaparoscope, general & plastic surgery12 reports
- ENDOPATH BASX CTB5LTLaparoscope, general & plastic surgery1 report
Recent ENDOPATH BASX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING THE UNK SURGERY, BEFORE USED ON THE PATIENT, NOTED THE PACKING WAS DAMAGED(AS THE PHOTO SHOWS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793225 ↗MalfunctionApr 3, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BEFORE USED ON THE PATIENT, OPENED THE PACKING, FOUND THE SEAL FILM DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779622 ↗MalfunctionApr 3, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BREATHER VALVE FELL OFF WAS FOUND DURING THE SURGERY. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779570 ↗InjuryJan 15, 2025Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE TROCARS WERE REMOVED, IT WAS DISCOVERED THAT A PIECE HAD BROKEN OFF THE INNER EDGE OF ONE TROCAR. THE BROKEN PIECES WERE THEN SEARCHED FOR IN THE ABDOMEN. AFTER A LENGTHY SEARCH, TWO SMALL PIECES WERE FOUND AND REMOVED. THE OPERATING TIME WAS GREATLY EXTENDED AND A SMALL PIECE OF THE TROCAR COULD NOT BE FOUND.
Patient problems: Foreign Body In Patient
MAUDE report 21164181 ↗MalfunctionJun 20, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS NOTED THE DEVICE WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19574790 ↗MalfunctionMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE DEVICE WAS RECEIVED WITH NO EVENT DETAILS. ATTEMPTS WERE MADE TO OBTAIN DETAILS AND NO INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857222 ↗MalfunctionJan 17, 2024Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS NOTED THE DEVICE WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18528219 ↗MalfunctionAug 18, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHEN OPENING THE PACKAGING IT WAS NOTED THE DEVICE WAS DAMAGED . ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17573581 ↗MalfunctionJul 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE THE SURGERY, IT WAS NOTED THAT THE STERILE PACKAGING WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17305267 ↗MalfunctionJun 29, 2023Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE TROCAR WAS REMOVED, IT WAS FOUND THAT A SMALL PIECE AT THE FRONT END OF THE TROCAR WAS DAMAGED. THE DAMAGED PART WAS STILL CONNECTED WITH THE TROCAR AND WAS NOT LEFT IN THE PATIENT'S BODY. CHANGED TO A NEW DEVICE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17229082 ↗MalfunctionJun 14, 2023Crack; Crack
IT WAS REPORTED THAT DURING AN ENDOSCOPIC STOMACH SURGERY, AFTER INSERT INTO THE TROCAR, NOTED ONE DEVICE WAS BROKEN ,AND ANOTHER DEVICE HAD CRACKS . ANOTHER TWO DEVICE WERE USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17130118 ↗MalfunctionJun 14, 2023Crack; Crack
IT WAS REPORTED THAT DURING AN ENDOSCOPIC STOMACH SURGERY, AFTER INSERT INTO THE TROCAR, NOTED ONE DEVICE WAS BROKEN ,AND ANOTHER DEVICE HAD CRACKS . ANOTHER TWO DEVICE WERE USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17130091 ↗MalfunctionMay 24, 2023Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR WAS NOTED BROKEN WHILE THE NURSE WAS CHECKING THE OPERATION ITEMS. AFTER CONFIRMING NO PIECES IN PATIENT, THE SURGEON COMPLETED THE SURGERY. HOWEVER, THE SURGERY WAS EXTENDED FOR ABOUT 2 HOURS DUE TO LOOKING FOR THE BROKEN PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16992935 ↗MalfunctionApr 7, 2023Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE TROCAR WAS BROKEN. PUNCH IS EVIDENT. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16700755 ↗MalfunctionApr 5, 2023Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR RUPTURED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16681044 ↗
Other Ethicon Endo-Surgery, LLC products
- Harmonic ACE9 models · 12,862 reports
- ECHELON FLEX7 models · 9,393 reports · 1 recall
- Harmonic13 models · 8,752 reports · 2 recalls
- ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 reports
- ECHELON Flex ENDOPATH7 models · 2,334 reports
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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