lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is ...
FDA Recall #Z-1517-2013 — Class II — March 4, 2009
Product Description
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Reason for Recall
Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.
Recalling Firm
Invatec Llc — Bethlehem, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
177 units
Distribution
Nationwide Distribution
Code Information
Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated