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Speedboat Notch Long

CREO MEDICAL LIMITED · Model PRD-SB1-003 · UDI-DI 05060359561077

KNS Prescription

510(k) clearances

17,612

Adverse events (83 deaths)

125

Recalls

117

Facilities

Description

Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract

Recalls

Date	Firm	Reason
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.

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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.