Recall Z-0669-2017— Terumo Medical Corp
Class II · Terminated
Class II FDA medical device recall by Terumo Medical Corp, initiated 2016-08-04, terminated 2017-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: MISAGO RX Self Expanding Peripheral Stem. 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..
- Recalling firm
- Terumo Medical Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-04
- Terminated
- 2017-10-19
- Firm location
- Somerset, NJ, United States
Product description
MISAGO RX Self Expanding Peripheral Stem
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.