Recall Z-0669-2017 ยท NIP Stent, Superficial Femoral Artery
Terumo Medical Corp
MISAGO RX Self Expanding Peripheral Stem
| Date | Aug 4, 2016 |
| Status | Terminated |
| 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, P |
| Quantity | 7,965 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.