SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Reported: November 24, 2021 Initiated: October 1, 2021 #Z-0220-2022
Product Description
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Reason for Recall
There is a potential for distal tip dislodgement or separation.
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 4 units
- Distribution
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.. Recalled by Cordis Corporation. Units affected: 4 units.
Why was this product recalled? ▼
There is a potential for distal tip dislodgement or separation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0220-2022.
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