Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
lnvatec SpA brand Diver C.E. Recalled by Invatec Llc Due to Devices labeled for an intended use was not...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Invatec Llc directly.
Affected Products
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.
Quantity: 177 units
Why Was This Recalled?
Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Invatec Llc
Invatec Llc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report