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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65289

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 04, 2009
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Invatec Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1517-2013
Recall number
Z-1517-2013
Initiated
March 04, 2009
Classification
Class II
Status
Terminated
Recalling firm
Invatec Llc
Quantity
177 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Nationwide Distribution