Invatec Llc: Medical Device Recall in 2013 - (Recall #: Z-1517-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 4, 2009

Date Posted: June 12, 2013

Recall Number: Z-1517-2013

Event ID: 65289

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.

Status: Terminated

Product Quantity: 177 units

Code Information:

Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated