FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1517-2013
- Recalling firm
- Invatec Llc
- 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.
- Status
- Terminated
- Initiated
- 2009-03-04
- Posted
- 2013-06-07
- Terminated
- 2013-06-10
- 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
- Lot, serial or model codes
- Serial Numbers/Batches: OPI05931901, OPI05684401, OPI05684501, OPI05684601, OPI05684701, OPI05684801
- 510(k) numbers
- ["K050276","K051917"]
- PMA numbers
- not on file
- Product code
- DXE
- Firm FEI
- 3006466080
- Firm city
- Bethlehem
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28