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Terminated

MISAGO RX Self Expanding Peripheral Stem

FDA Recall Z-0669-2017 · Posted None

Recalling FirmTerumo Medical Corp
Recall StatusTerminated
Product CodeNIP
Date Initiated2016-08-04
Date Terminated2017-10-19
Product Quantity7,965 units

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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