Exact FDA event identifier

Event 84410

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

Open FDA event record

Event summary

Timeline bucket: November 14, 2019
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 Affinity, 38um Arterial Filter, Catalog number REF 351

Z-0693-2020

Recall number: Z-0693-2020
Initiated: November 14, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtronic Perfusion Systems
Quantity: 24 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of-specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.

Code information

UDI 20643169858835, Lot Numbers: 13316512

Distribution pattern

CA