Z-1517-2013 Class II Terminated
FDA device recall Z-1517-2013 was initiated by Invatec Llc on March 4, 2009 and is designated Class II. 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. The recall status is terminated (terminated June 10, 2013). Affected quantity: 177 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2013
- Initiation Date
- March 4, 2009
- Termination Date
- June 10, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 177 units
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.
Distribution Pattern
Nationwide Distribution
Code Information
Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801