FDA-Device2016-12-07Class II
MISAGO RX Self Expanding Peripheral Stem
Terumo Medical Corp
Hazard
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.
Sold states
Nationwide
Affected count
7,965 units
Manufactured in
2101 Cottontail Ln, Somerset, NJ, United States
Products
MISAGO RX Self Expanding Peripheral Stem
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2017Don't want to check this manually?
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