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SmartBand EMR Kit

INTELLIGENT ENDOSCOPY LLC · Model SBEMRK94 · UDI-DI 00850261006217

FDI Prescription
10
510(k) clearances
4,673
Adverse events (10 deaths)
18
Recalls
61
Facilities

Description

The SmartBand EMR Kit (9.4mm) 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.