CLASS II Device recall · Reported 7 Dec 2016 · FDA Enforcement Report

Misago RX Self Expanding Peripheral Stem recalled by Terumo Medical

Terumo Medical is recalling Misago RX Self Expanding Peripheral Stem, distributed nationwide in the US. The recall was initiated on 4 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes150401 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

Quantity recalled7,965 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0669-2017
FDA event ID: 75370
Recalling firm: Terumo Medical, Somerset, NJ
Classification: Class II
Status: Terminated
Recall initiated: 4 Aug 2016
FDA classified: 29 Nov 2016
Reported: 7 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Aug 2016	Recall initiated by company
29 Nov 2016	Classified by FDA	+117 days
7 Dec 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

MISAGO RX Self Expanding Peripheral Stem

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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