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electrodeCU

COSMAN MEDICAL, LLC · Model CU-6522 · UDI-DI 08132500157686

GXI Prescription

510(k) clearances

897

Adverse events (6 deaths)

Recalls

Facilities

Description

Electrode 6cm, 5mm Tip, 22G

Recalls

Date	Firm	Reason
2026-04-29	Boston Scientific Neuromodulation Corporation	Reusable electrodes may not meet expected performance levels.
2026-04-29	Boston Scientific Neuromodulation Corporation	Reusable electrodes may not meet expected performance levels.
2026-04-22	Boston Scientific Neuromodulation Corporation	Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to
2024-06-03	Stryker Corporation	Expired Products distributed to customers
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08	Medtronic Sofamor Danek USA Inc	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-02-21	Epimed International	Incorrect expiration date on introduction cannula packaging.

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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.