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Speedband Superview Super 7
BOSTON SCIENTIFIC CORPORATION · Model M00542250 · UDI-DI 08714729201953
10
510(k) clearances
10,683
Adverse events (71 deaths)
5
Recalls
28
Facilities
Description
Multiple Band Ligator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-30 | Olympus Corporation of the Americas | Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy. |
| 2023-02-23 | Olympus Corporation of the Americas | There have been complaints that the clip did not come out of the tube sheath during the procedure. |
| 2020-10-05 | Micro-Tech Usa | FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US. |
| 2011-06-07 | Cook Endoscopy | The disposable clip may not deploy after being positioned inside the patient. |
| 2010-09-03 | Cook Endoscopy | A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.