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ASCENDO submucosal lifting agent

US Endoscopy · Model 00712935 · UDI-DI 00724995231866

PLL
1
510(k) clearances
70
Adverse events
1
Recalls
13
Facilities

Recalls

DateFirmReason
2022-10-10Boston Scientific Corporation***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORl

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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.