lnvatec SpA brand Diver C — Class II medical device recall Z-1517-2013
Terminated recall by Invatec Llc, reported 2013-06-12, distributed nationwide. Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications f
| Recall number | Z-1517-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invatec Llc, Bethlehem, PA, United States |
| Recall initiated | 2009-03-04 |
| Classified | 2013-06-06 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2013-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 177 units |
| Reason classes | labeling |
| Lot numbers | OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801, OPI05931901 |
| Model numbers | DVR010014145, DVR011014145 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1517-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.