Z-1517-2013Class II

lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by...

Name: Z-1517-2013 lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by...
Creator: Invatec Llc
Published: 2009-03-04
License: https://open.fda.gov/license/

Invatec S.p.A. / initiated 2009-03-04 / Terminated / root cause: labeling and UDI

FDA source

Invatec Llc began a recall of lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by... on 2009-03-04. FDA classified it as Class II and gives the reason as "Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1517-2013
Classification: Class II
Status: Terminated
Initiated: 2009-03-04
Posted: 2013-06-07
Terminated: 2013-06-10
Recalling firm: Invatec S.p.A.
Product: 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 code: DXE Catheter, Embolectomy
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 177 units
Distribution: Nationwide Distribution
Product codes and lots: Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1517-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1517-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

Product code DXE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)