Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85092

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

Open FDA event record

Event summary

Timeline bucket
February 11, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MEDTRONIC ATS MEDICAL, INC.

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

Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

Z-1533-2020
Recall number
Z-1533-2020
Initiated
February 11, 2020
Classification
Class II
Status
Terminated
Quantity
2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.

Code information

UDI 00643169297913, Serial Numbers: 935603, 935732

Distribution pattern

China