SmartBand Ligation Kit SLK-6Recalls & reported problems
Intelligent Endoscopy LLC · Multi-Band Ligation Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850261006019), received between Dec 23, 2025 and Dec 23, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Failure to Advance; Failure to Advance
THE USER FACILITY REPORTED THAT WHEN APPLYING THE SECOND BAND OF THEIR SMARTBAND MULTI-BAND LIGATION KIT, THE BAND FAILED TO DEPLOY ONTO THE VARIX AND WAS SITTING IN THE ESOPHAGUS. THE USER FACILITY WAS ABLE TO QUICKLY RETRIEVE THE BAND AND SUCCESSFULLY DEPLOY A THIRD BAND ON THE VARIX. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879035 ↗
Other Ligator, hemorrhoidal devices
- ShortShot G34063Cook Ireland Ltd · Ligator, hemorrhoidal31 reports
- SmartBand SafeGrip Multi-Band Ligation Kit SLK-6-LFIntelligent Endoscopy LLC · Ligator, hemorrhoidal9 reports
- SmartBand SafeGrip Multi-Band Ligation Kit SLK6LFUS Endoscopy · Ligator, hemorrhoidal3 reports
- SPACEBANDER HB1020Conmed Corporation · Ligator, hemorrhoidal1 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 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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