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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71897

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

Open FDA event record

Event summary

Timeline bucket
July 24, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Perfusion Systems

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 EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.

Z-2420-2015
Recall number
Z-2420-2015
Initiated
July 24, 2015
Classification
Class II
Status
Terminated
Quantity
221 (111 US, 110 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.

Code information

Lot number 2015060544;

Distribution pattern

Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.