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Acrostak Schweiz AG manufactured the M-Cath Microcatheter and M-Cath Flexy Microcatheter, cardiovascular devices intended for coronary intervention procedures, but failed to obtain required 510(k) clearance before marketing the M-Cath Flexy Microcatheter in 2021. The M-Cath Flexy model contained multiple significant design modifications including different material grades, additional braided layers, altered tip design, and extended length (150 cm) compared to the cleared device, creating potential exposure to new or different chemical amounts for patients. These undisclosed changes violated 21 CFR 807.81(a)(3) requirements for substantial equivalence documentation and represented adulteration of a medical device under CGMP/QSR regulations.