Reported Dec 7, 2016 · Terminated

MISAGO RX Self Expanding Peripheral Stem

Terumo Medical Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Terumo Medical Corp · 2101 Cottontail Ln · Somerset, NJ · 08873-1277

Is this the product you have?

  • MISAGO RX Self Expanding Peripheral Stem
Lot codes and dates
  • 113 of 113 codes

    • 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
Amount recalled
7,965 units

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 19, 2017 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.