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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75370

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

Open FDA event record

Event summary

Timeline bucket
August 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Medical Corp

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

MISAGO RX Self Expanding Peripheral Stem

Z-0669-2017
Recall number
Z-0669-2017
Initiated
August 04, 2016
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
7,965 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.

Code information

150401 150429 150713 150821 150923 151009 160314 150413 150501 150708 150824 150915 151013 151111 150415 150515 150701 150716 150902 151005 151106 150407 150514 150707 150827 151008 151109 160509 150406 150501 150713 150716 150825 151001 151102 160315 160509 150410 150710 150831 150909 151007 151012 151014 151103 151208 150417 150429 150717 150910 151002 151102 160510 150408 150429 150701 150717 150831 151013 151103 160512 150409 150430 150518 150703 150706 150903 150914 151005 150331 150430 150708 150714 150904 150910 151001 151102 150414 150429 150715 150903 151005 151029 160323 150416 150518 150715 150908 150915 151002 151106 160328 150401 150430 150716 150828 151006 150403 150514 150717 150901 150909 151012 150408 150430 150713 150907 151001 150402 150512 150713 150907 151001

Distribution pattern

Nationwide

Field note

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