SMART FLEX Biliary Stent System Recalled for Potential Distal Tip Dislodgement
Cordis Corporation is recalling 4 units of the SMART FLEX 10x100 BIL biliary stent system (Lot No. 271626) due to a potential for distal tip dislodgement or separation. The affected units were distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a potential device malfunction (distal tip dislodgement). No illnesses, injuries, or hospitalizations have been reported. Since the hazard is theoretical and no harm has been documented, the severity is High per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Cordis Corporation is recalling 4 units of the SMART FLEX 10x100 BIL, 120cm biliary stent system (Product Code SF10100MB, Lot No. 271626). This medical device is used to treat blockages in the bile ducts caused by malignant strictures.
The recall was initiated because of a potential for distal tip dislodgement or separation of the stent. No illnesses or injuries have been reported in connection with this issue.
The affected units were distributed to healthcare facilities in California, Florida, Indiana, Louisiana, Ohio, Oklahoma, Texas, and Canada. Patients and healthcare providers who have received or implanted devices from this lot should contact Cordis Corporation for additional information and guidance.
The recalled product
- Product
- SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Manufacturer
- Cordis Corporation
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: SF10100MB
- Lot No. 271626
Distribution
Part of a larger recall action
This product is one of 6 recalled by Cordis Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Cordis Corporation
See all →- HighSMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighSMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighCordis SMART FLEX Biliary Stent System recalled for potential tip separation
FDA (Devices) · 2021-11-24
- HighCordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation
FDA (Devices) · 2021-11-24
- HighFDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk
FDA (Devices) · 2021-11-24
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