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MEDTRONIC XOMED, INC. · Model 8227301 · UDI-DI 20643169294367

IKTGXZFMI Prescription
1
510(k) clearances
150
Adverse events
2
Recalls
39
Facilities

Description

ELECTRODE 8227301 5PK PRASS PR 25MM ROHS

Recalls

DateFirmReason
2022-08-09Technomed EuropeBurns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
2007-04-12Chalgren Enterprises IncSterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.

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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.