Speedband Superview Super 7 M00542250Recalls & reported problems
Boston Scientific Corporation · Multiple Band Ligator · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Boston Scientific Speedband Superview Super 7 is an esophageal band ligator. Reports most often describe the bands failing to fire, and some describe bands firing early or breaking. The device appears in 4,688 reports, including 6 deaths and 61 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 4,728
- Deaths reported
- 6
- Injuries reported
- 62
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,728 adverse event reports that list this exact device (DI 08714729201953), received between Jan 1, 2017 and Sep 30, 2026 — classified as 6 deaths, 62 injuries, 4,660 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (3,443 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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire3,443
- Premature Activation591
- Break478
- Use of Device Problem443
- Adverse Event Without Identified Device or Use Problem359
- Material Integrity Problem275
- Human-Device Interface Problem150
- Positioning Failure140
Patient problems
- No Clinical Signs, Symptoms or Conditions3,482
- No Consequences Or Impact To Patient1,083
- No Known Impact Or Consequence To Patient111
- Hemorrhage/Blood Loss/Bleeding105
- Insufficient Information17
- No Patient Involvement9
- No Code Available8
- Unspecified Tissue Injury7
Recent adverse event reports
The 25 most recent of 4,728 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948647 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940540 ↗MalfunctionSep 29, 2026Premature Activation; Failure to Fire
It was reported to Boston Scientific Corporation that a Speedband Superview Super 7 was used for Varicose veins in the esophagus during an Endoscopic Selective Varices Devascularization (ESVD) procedure performed on (b)(6) 2026.During the procedure, two bands were deployed at a time, and then other bands could not be deployed. The procedure was completed with another Speedband Superview Super 7. It was noted that no difficulty was experienced upon setting up the device.There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934819 ↗MalfunctionSep 29, 2026Failure to Fire
It was reported to Boston Scientific Corporation that a Speedband Superview Super 7 device was used during a procedure performed on (b)(6) 2026.During the procedure, one band was successfully deployed but after that no additional bands could be deployed. It appeared as one band shifted over the remaining bands preventing deployment. No additional information was provided regarding how the procedure was completed.No information regarding patient outcome was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934677 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934397 ↗MalfunctionSep 28, 2026Failure to Fire; Human-Device Interface Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926450 ↗MalfunctionSep 28, 2026Failure to Fire; Human-Device Interface Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926448 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874847 ↗MalfunctionSep 22, 2026Failure to Fire; Material Integrity Problem
It was reported to Boston Scientific Corporation that a Speedband Superview Super 7 device was used in the esophagus during a procedure performed on (b)(6) 2026 for the treatment of esophageal variceal ligation.During preparation, the bands entangled and broke. This event occurred outside the patient. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857811 ↗MalfunctionSep 21, 2026Detachment of Device or Device Component
It was reported to Boston Scientific Corporation that a Band Ligation was used in the Gastrointestinal track during a Internal hemorrhoid ligation procedure performed on (b)(6) 2026.Upon preparation a Speedband Super 7 had the release cords not properly secured for the first three bands, the device was immediately substituted. The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842172 ↗MalfunctionSep 21, 2026Failure to Fire
It was reported to Boston Scientific Corporation that a Band Ligation was used in the intestine for an Endoscopic hemostasis procedure performed on (b)(6) 2026.During the procedure the 4th band failed to deploy. The procedure was completed with another of the same device.There were no patient complications reported as a result of this event. The patient condition is stable after the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842169 ↗MalfunctionSep 21, 2026Failure to Fire
It was reported to Boston Scientific Corporation that a Band Ligation was used in an unknown location for an esophageal varices treatment via gastroscopy procedure performed on (b)(6) 2026.During the procedure the bands were stuck together, and it could not be deployed normally. The procedure was completed with another of the same device.There were no patient complications reported as a result of this event. The patient condition is stable after the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842168 ↗MalfunctionSep 21, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842167 ↗MalfunctionSep 17, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810350 ↗InjurySep 16, 2026Failure to Fire
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Irritation
MAUDE report 50796663 ↗MalfunctionSep 16, 2026Use of Device Problem; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796535 ↗MalfunctionSep 16, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790749 ↗MalfunctionSep 11, 2026Failure to Fire
It was reported to Boston Scientific Corporation that a Speedband Superview Super 7 device was used in the esophagus during an Endoscopic band ligation procedure performed on 18 AUG 2026 for the treatment of esophageal varices. During the procedure, the first two bands failed to deploy. Instead of releasing the bands remained positioned proximally on the applicator barrel. There were no difficulties setting up the device. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734243 ↗MalfunctionSep 11, 2026Failure to Fire
It was reported to Boston Scientific Corporation that a Band Ligation was used in the esophagus during a Endoscopic variceal ligation procedure performed on (b)(6) 2026.During the procedure, the super 7 bands were entangled and failed to deploy. The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733979 ↗MalfunctionSep 11, 2026Failure to Fire
It was reported to Boston Scientific Corporation that a Speedband Superview Super 7 device was used in the esophagus during an Esophageal variceal ligation procedure performed on (b)(6)2026 for the treatment of esophageal varices.During the procedure, the mechanical structure of the ligation device was abnormal, and the band could not be deployed normally. The ligation operation could not be completed. There was no difficulties setting up the device. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733902 ↗MalfunctionSep 10, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717990 ↗MalfunctionSep 10, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716541 ↗MalfunctionSep 10, 2026Use of Device Problem; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716338 ↗MalfunctionSep 9, 2026Failure to Fire
It was reported to Boston Scientific Corporation that a Speedband Superview Super 7 device was used in the esophagus during an Esophageal Variceal Ligation procedure performed on (b)(6) 2026 for the treatment of esophageal variceal ligation (EVL).During the procedure, when the third band was deployed, it was found that the bands were twisted together and it could not be deployed. There was no difficulties setting up the device. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695576 ↗MalfunctionSep 9, 2026Premature Activation; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695457 ↗
Other Ligator, esophageal devices
- 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
- Single Use Rotatable Clip Fixing Device HX-201LR-135Olympus Medical Systems Corp. · Ligator, esophageal1 recall0 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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