Recall Z-1511-2013— Cordis Corporation
Class II · Terminated
Class II FDA medical device recall by Cordis Corporation, initiated 2013-04-23, terminated 2014-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.. Reason: Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch..
- Recalling firm
- Cordis Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-23
- Terminated
- 2014-06-27
- Firm location
- Miami Lakes, FL, United States
Product description
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Reason for recall
Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Data sourced from openFDA. This site is unofficial and independent of the FDA.