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FIAB SPA · Model F7244 · UDI-DI 18033695727142

GEI Prescription
1
510(k) clearances
119,015
Adverse events (469 deaths)
644
Recalls
862
Facilities

Description

HTC (high temperature cautery) F7244 model is a sterile bipolar battery operated disposable device used for the cauterization of tissues and capillary vessels. F7244 model is equipped with fine tip that permits the cauterization of very small vessels and is suitable to be used all the times a quick and precise cauterization is necessary. F7244 reaches a maximum working temperature of 1.200°C (2.200 °F).

Recalls

DateFirmReason
2026-08-18Olympus Corporation of the AmericasPotential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
2026-06-08Stryker CorporationThere has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-08Stryker CorporationThere has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-02Maquet Cardiovascular, LLCGetinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-2878
2026-03-23Olympus Corporation of the AmericasPotential for detachment of a distal tip component of the device during use.
2026-03-23Olympus Corporation of the AmericasPotential for detachment of a distal tip component of the device during use.
2026-03-23Olympus Corporation of the AmericasPotential for detachment of a distal tip component of the device during use.
2026-03-23Olympus Corporation of the AmericasPotential for detachment of a distal tip component of the device during use.
2026-02-25Olympus Corporation of the AmericasOlympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting For
2026-02-25Olympus Corporation of the AmericasOlympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting For

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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.