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SPINERY Needle

AXON SRL · Model SP-BI0704 · UDI-DI 00860011603603

GEI Prescription

510(k) clearances

119,015

Adverse events (469 deaths)

644

Recalls

862

Facilities

Description

Spinery (RF) Needles are composed by a handle with electrode cooled needle and are offered in bipolar configurations. The available variants consist of cooled needles capable of providing irrigation of tissue through needle tip during ablation procedure. The needle is hollow and its inner space is divided into 3 concentric lumens: • the inner central lumen is used to distally deliver the irrigation solution to the tip of the RF needle; a hole on the needle tip allows the irrigation solution to reach tissues (the irrigation solution could be also delivered proximally through the insulation and irrigation cannula); • the intermediate lumen is used to deliver a cooling fluid through the proximal SpineryTM RF Ablation System by Axon Spine Medical Systems thermocouple; • the outer external lumen returns the cooling fluid from the proximal thermocouple towards the cooling tubing circuit connected to the handle of the RF needle device; the cooling fluid is not intended to come in contact with patient tissue because it flows in a closed circuit. The needles also contain two thermocouples, a distal thermocouple inside the ablation area and proximal thermocouple at the edge of ablation area that permit real-time monitoring of temperatures at the center of the ablation zone and at the edge of ablation area ensuring that no healthy tissue around tumor is damaged.

Recalls

Date	Firm	Reason
2026-08-18	Olympus Corporation of the Americas	Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
2026-06-08	Stryker Corporation	There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-08	Stryker Corporation	There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-02	Maquet Cardiovascular, LLC	Getinge 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
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-02-25	Olympus Corporation of the Americas	Olympus 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
2026-02-25	Olympus Corporation of the Americas	Olympus 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.