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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Medical Corporation

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  Class 2 Device Recall Terumo Medical Corporation see related information
Date Initiated by Firm August 04, 2016
Create Date November 29, 2016
Recall Status1 Terminated 3 on October 19, 2017
Recall Number Z-0669-2017
Recall Event ID 75370
PMA Number P140002 
Product Classification Stent, superficial femoral artery - Product Code NIP
Product MISAGO RX Self Expanding Peripheral Stem
Code Information 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  
Recalling Firm/
Manufacturer		 Terumo Medical Corp
2101 Cottontail Ln
Somerset NJ 08873-1277
For Additional Information Contact
800-283-7866
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 7,965 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NIP and Original Applicant = TERUMO MEDICAL CORPORATION
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