SPACEBANDER HB1020Recalls & reported problems
Conmed Corporation · SPACEBANDER DISPOSABLE HEMORRHOID LIGATOR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405005469), received between Apr 18, 2019 and Apr 18, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HB1020 DEVICE WAS USED DURING A HEMORRHOID BANDING ON (B)(6) 2019. IT IS REPORTED THAT THE BAND REMAINED ON THE PATIENT AFTER 13 DAYS AND THEN THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING. THE PATIENT HAD BEEN BANDED IN THE RIGHT QUADRANT. THE PATIENT PALPATED THE BAND AROUND THE 12TH DAY, AND THE FOLLOW DAY THE PATIENT EXPERIENCED SPONTANEOUS BLEEDING. FURTHER ASSESSMENT FOUND THAT THE PATIENT HAD USED A FINGER TO MANUALLY MANIPULATE THE BAND IN THE RECTUM. THE FACILITY STATES THAT THEY HAD NOT ADVISED THE PATIENT TO PALPITATE THE BAND. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT PER THE FACILITY. THE PHYSICIAN STATED THAT HIS PRIMARY CONCERN WAS THE INTEGRITY OF THE DEVICE SINCE IT WAS A PRE-LOADED DEVICE. THE PHYSICIAN HYPOTHESIZED THAT THE QUALITY OF THE BANDS MAY BE COMPROMISED FROM BEING LOADED ON THE DEVICE FOR WEEKS/MONTHS BEFORE BEING DEPLOYED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE PATIENT BLEEDING CAUSED A NEED TO RETURN TO THE FACILITY FOR FOLLOW UP DUE TO BLEEDING.
Patient problems: Blood Loss
MAUDE report 8528393 ↗
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- 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
- SmartBand Ligation Kit SLK-6Intelligent Endoscopy LLC · 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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