FDAFDA · Food and drugs·Recall number Z-1517-2013
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.
Published June 12, 2013 · Recall initiated: March 4, 2009
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Invatec Llc
- Distributor
- Nationwide Distribution
- Lot
- Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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