FDA Medical Device Recalls (openFDA)
Terumo Medical Corp: MISAGO RX Self Expanding Peripheral Stem
- Recall number
- Z-0669-2017
- Recalling firm
- Terumo Medical Corp
- Product
- MISAGO RX Self Expanding Peripheral Stem
- Status
- Terminated
- Initiated
- 2016-08-04
- Posted
- not on file
- Terminated
- 2017-10-19
- Reason
- 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
- 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 misago.rc@terumomedical.com 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: misago.rc@terumomedical.com - Customer Care: 1.800.888.3786 - Contact your local Terumo representative
- Quantity
- 7,965 units
- Distribution
- Nationwide
- Lot, serial or model 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 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P140002"]
- Product code
- NIP
- Firm FEI
- 2243441
- Firm city
- Somerset
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28