Reported Jun 12, 2013 · Terminated
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec…
Invatec LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Invatec Llc · 3101 Emrick Blvd · Bethlehem, PA · 18020-8037
Is this the product you have?
- lnvatec SpA brand Diver C.E
- Model/Catalog NumbersDVR010014145, 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
- Lot codes and dates
- Serial Numbers/Batches
OPI05931901OPI05684401OPI05684501OPI05684601OPI05684701OPI05684801
- Serial Numbers/Batches
- Amount recalled
- 177 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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