Recall Z-1517-2013 ยท DXE Catheter, Embolectomy
Invatec Llc
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.
| Date | Jun 7, 2013 (initiated Mar 4, 2009) |
| Status | Terminated |
| Reason | Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified. |
| Root cause | Labeling False and Misleading |
| Action | Invatec sent an Urgent - Device Field Action letter dated March 4, 2009, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were required to return a confirmation form, acknowledging the action taken, and identifying affected units in their inventory for return of the product for replacement. The firm indicated that this recall was fully executed in 2009, and this 806 captures the events that took place at that time. For questions regarding this recall call 707-566-1143. |
| Quantity | 177 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |