ProdiGI ERD-TW35Recalls & reported problems
Covidien LP · Traction Wire · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521806870), received between Jun 21, 2021 and Feb 29, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CLIP OF THE TRACTION WIRE SNAPPED UPON DEPLOYMENT, SO IT COULDN'T BE USED. NOTHING ABNORMAL WAS NOTICED PRIOR TO DEPLOYMENT. GRASPING FORCEPS WAS USED TO RETRIEVE BOTH THE WIRE AND THE BROKEN CLIP PIECE DURING THE SAME PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 18813071 ↗InjuryJun 21, 2021Difficult to Remove; Difficult to Remove
ACCORDING TO THE REPORTER, THE PHYSICIAN DROPPED THE DEVICE INTO THE PATIENT'S DUODENUM DURING THE PROCEDURE. THE PHYSICIAN SEEMED TO HAVE BEEN SOME DIFFICULTIES OR MISTAKE WHEN PLACING THE WIRE (GRASPER 1) AND REMOVED THE SECOND GRASPER AND THOUGHT THE PATIENT MIGHT HAVE GOT A DAMAGE TO THE BOWEL WALL. THE DEVICE WAS OUT OF SIGHT FOR THE ENDOSCOPE VIEW AND COULD NOT BE REACHED. THERE WAS A SUSPECTED PERFORATION AND CLIP PLACEMENT WAS PERFORMED FOR SAFETY. MEDICATION WAS GIVEN TO THE PATIENT TO MAKE THE BOWEL CALMER AND HAD BEEN ON IV FEEDING FOR SOME TIME. A CT WAS PERFORMED AND SHOWED THE DEVICE PASSED ALL BOWEL UNTIL THE LAST PART OF THE SMALL BOWEL. THEY WILL PLAN A NEW CT IN THE COMING 1-2 WEEKS TO CONTROL IF THE DEVICE PASSED ALL THE BOWEL OR NOT. ALL PATIENTS FAST IN THE DAYS AFTER DUODENAL ESD IRRESPECTIVE OF COMPLICATIONS OR NOT. USUALLY 2-3 DAYS DUE TO THE RISK OF DELAYED BLEEDING OR DELAYED PERFORATION DUE TO THE PANCREATIC AND BILIARY JUICE. THE PATIENT WAS INFORMED ON EVERYTHING.
Patient problems: Foreign Body In Patient
MAUDE report 12030765 ↗
Other Endoscopic Traction Device devices
- ProdiGI ERD-TWSGCovidien LP · Endoscopic Traction Device1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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