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SmartBand EMR Kit

INTELLIGENT ENDOSCOPY LLC · Model SBEMRK · UDI-DI 00850261006071

FDI Prescription
1
510(k) clearances
4,658
Adverse events (10 deaths)
18
Recalls
60
Facilities

Description

SmartBand EMR Kit (10.75mm) is indicated for endoscopic mucosal resection in the upper GI tract.

Recalls

DateFirmReason
2025-10-06Olympus Corporation of the AmericasSterility 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.
2025-10-06Olympus Corporation of the AmericasSterility 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.
2021-01-19Boston Scientific CorporationPackaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2021-01-19Boston Scientific CorporationPackaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2021-01-19Boston Scientific CorporationPackaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
2020-07-06Boston Scientific CorporationBSC 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
2020-07-06Boston Scientific CorporationBSC 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
2020-07-06Boston Scientific CorporationBSC 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
2020-07-06Boston Scientific CorporationBSC 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
2020-07-06Boston Scientific CorporationBSC 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.