Histolock 00711117Recalls & reported problems
US Endoscopy · The Histolock resection device is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995182625), received between Apr 25, 2024 and May 1, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem1
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Difficult to Open or Close
THE USER FACILITY REPORTED VIA MEDWATCH #5184607 THAT DURING A PATIENT PROCEDURE THE SNARE TO THEIR HISTOLOCK RESECTION DEVICE PROTRUDED OUTSIDE OF THE PLASTIC SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER THE SNARE WAS FED BACK INTO THE SHEATH AND THE POLYP WAS RELEASED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056261 ↗MalfunctionApr 25, 2024Device Handling Problem; Device Handling Problem
THE USER FACILITY REPORTED THAT THE HISTOLOCK RESECTION DEVICE GOT CAUGHT ON TISSUE DURING A PATIENT PROCEDURE. THE PATIENT PROCEDURE WAS SUCCESSFULLY COMPLETED FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19184365 ↗
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- SENSATION Short Throw M00562650Boston Scientific Corporation · SNARE, FLEXIBLE1 recall173 reports
- Ultratome XL M00535900Boston Scientific Corporation · SNARE, FLEXIBLE205 reports
- CAPTIVATOR M00562340Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls71 reports
- CAPTIVATOR II M00561230Boston Scientific Corporation · SNARE, FLEXIBLE1 recall83 reports
- CAPTIVATOR M00562320Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls32 reports
- CAPTIVATOR M00562300Boston Scientific Corporation · SNARE, FLEXIBLE1 recall78 reports
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 14, 2026 · each report above links to its original FDA record
- 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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