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Histofreezer FLEX

CRYOCONCEPTS, LP · Model 200-4051 · UDI-DI 00850077006357

GEH Prescription
1
510(k) clearances
3,252
Adverse events (57 deaths)
106
Recalls
109
Facilities

Description

Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.

Recalls

DateFirmReason
2026-06-26Erbe USA IncA strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the
2026-02-12Erbe USA IncProbes may rupture/burst during activation
2026-02-12Erbe USA IncProbes may rupture/burst during activation
2026-02-12Erbe USA IncProbes may rupture/burst during activation
2025-08-18Boston Scientific CorporationCertain desiccant tube subassemblies were built with end caps that were not correctly tightened.
2025-08-18Boston Scientific CorporationCertain desiccant tube subassemblies were built with end caps that were not correctly tightened.
2025-03-24Boston Scientific CorporationBoston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings
2025-03-24Boston Scientific CorporationBoston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings
2025-03-24Boston Scientific CorporationBoston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings
2025-03-24Boston Scientific CorporationBoston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings

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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.