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SmartBand EMR Pack

INTELLIGENT ENDOSCOPY LLC · Model SBEMRP94 · UDI-DI 00850261006200

FDI Prescription

510(k) clearances

4,673

Adverse events (10 deaths)

Recalls

Facilities

Description

SmartBand EMR Ligator Pack (9.4 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable barrel of bands for procedures requiring more than 5 bands.

Recalls

Date	Firm	Reason
2025-10-06	Olympus Corporation of the Americas	Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
2025-10-06	Olympus Corporation of the Americas	Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
2021-01-19	Boston Scientific Corporation	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2021-01-19	Boston Scientific Corporation	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2021-01-19	Boston Scientific Corporation	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2020-07-06	Boston Scientific Corporation	BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr
2020-07-06	Boston Scientific Corporation	BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr
2020-07-06	Boston Scientific Corporation	BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr
2020-07-06	Boston Scientific Corporation	BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr
2020-07-06	Boston Scientific Corporation	BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged pr

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Data 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.