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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88606

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

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Event summary

Timeline bucket
August 25, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Atrium Medical Corporation

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

Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Z-2589-2021
Recall number
Z-2589-2021
Initiated
August 25, 2021
Classification
Class II
Status
Terminated
Quantity
28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.

Code information

Lot 458755 Serial numbers 458755001 458755007 458755013 458755019 458755025 458755002 458755008 458755014 458755020 458755026 458755003 458755009 458755015 458755021 458755027 458755004 458755010 458755016 458755022 458755028 458755005 458755011 458755017 458755023 458755029 458755006 458755012 458755018 458755024 458755030

Distribution pattern

Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.