Auto-Band® DBL-330Recalls & reported problems
Endochoice, Inc. · Ligator Assembly & Band Barrel w/7 non-Latex Bands · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816849010007), received between Aug 24, 2017 and Aug 24, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (2 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, 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 18, 2026.
Most reported problems
Device problems
- Positioning Failure2
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2017Positioning Failure; Positioning Failure
DURING VARICEAL LIGATION, THE ELASTIC BANDS DID NOT DEPLOY. THE EDGE OF THE BARREL ASSEMBLY CAUSED BLEEDING AT THE BASE OF THE VARIX. THE DEVICE WAS CHECKED PRIOR TO THE ENDOSCOPY AND FUNCTIONED, BUT DID NOT WORK DURING THE CASE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 6816603 ↗MalfunctionAug 24, 2017Positioning Failure; Positioning Failure
DURING VARICEAL LIGATION, THE ELASTIC BANDS DID NOT DEPLOY. THE EDGE OF THE BARREL CAUSED BLEEDING AT THE BASE OF THE VARIX WHICH HAD NOT BEEN BLEEDING PREVIOUSLY. THE BANDING DEVICE WAS CHECKED BEFORE STARTING ENDOSCOPY AND FUNCTIONED, BUT DID NOT WORK DURING THE CASE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 6816539 ↗
Other Ligator, Esophageal devices
- Speedband Superview Super 7 M00542250Boston Scientific Corporation · Ligator, esophageal6 deaths4,728 reports
- Saeed G22692Cook Incorporated · Ligator, esophageal295 reports
- Saeed G22553Cook Incorporated · Ligator, esophageal289 reports
- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal1 recall239 reports
- Saeed G31917Cook Incorporated · Ligator, esophageal123 reports
- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal97 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135Olympus Medical Systems Corp. · Ligator, esophageal1 recall1 death10 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135LOlympus Medical Systems Corp. · Ligator, esophageal1 recall8 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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