Acrostak Schweiz AG

Warning LetterOpen

Mr. Youri G. Popowski CEO Acrostak Schweiz AG Stegackerstrasse 14 Winterthur 8409 Zurich SwitzerlandFEI 3005086865Issued Oct 31, 2023Center for Devices and Radiological Health

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Violations6

Issue DateOct 31, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Acrostak Schweiz AG
Location: Mr. Youri G. Popowski CEO Acrostak Schweiz AG Stegackerstrasse 14 Winterthur 8409 Zurich Switzerland
FEI Number: 3005086865
Country: Switzerland
Issue Date: October 31, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Acrostak Schweiz AG FDA Warning Letter, October 31, 2023