Z-0669-2017Class II

MISAGO RX Self Expanding Peripheral Stem

Name: Z-0669-2017 MISAGO RX Self Expanding Peripheral Stem
Creator: Terumo Medical Corp
Published: 2016-08-04
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2016-08-04 / Terminated / root cause: design

FDA source

Terumo Medical Corp began a recall of MISAGO RX Self Expanding Peripheral Stem on 2016-08-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0669-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-04
Posted: 2016-11-29
Terminated: 2017-10-19
Recalling firm: Terumo Medical Corp.
Product: MISAGO RX Self Expanding Peripheral Stem
Product code: NIP Stent, Superficial Femoral Artery
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.
Root cause tag: design
FDA root cause: Device Design
Action: Terumo Medical Corporation issued an Urgent Product Recall Bulletin dated August 4, 2016, via Fed Ex. Customers must immediately discontinue use and quarantine any available stock of the Misago peripheral stent to prevent further use. The customers should complete the enclosed Inventory Confirmation form as soon as possible and email or fax the completed form to [email protected] or (734) 330-2034, Attn: MISAGO Recall. Customers are encourage you to contact Terumo Medical Corporation with any questions or concerns -Terumo Medical Corporation Quality Department: 1.800.283.7866, Press 4 for list of departments, Press 7 for Quality Assurance; Monday Friday, 8 a.m. 5 p.m. ET - Email Quality Assurance: [email protected] - Customer Care: 1.800.888.3786 - Contact your local Terumo representative
Quantity in commerce: 7,965 units
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0669-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0669-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-29

Product code NIP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)