The Recall Desk
HighFDA (Devices)·Z-0220-2022·Announced 2021-11-24

Cordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation

Cordis Corporation is recalling the SMART FLEX Biliary Stent System (Lot 266586) due to potential distal tip dislodgement or separation. Affected units were distributed to select US states and Canada.

What this means for you

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 medical device recall for a risk-of-harm product where the potential for distal tip dislodgement could compromise stent function. No adverse events or hospitalizations are reported in the source material, meeting the criterion for Score 3 (risk-of-harm products where injury has not yet been reported).

Plain-English summary

Cordis Corporation is recalling the SMART FLEX 10x100 BIL, 80cm Biliary Stent System. The recalled lot (No. 266586) consists of 4 units and was distributed to the United States and Canada. The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

The recall is due to a potential for distal tip dislodgement or separation. The affected units were distributed in the United States to the states of California, Florida, Indiana, Louisiana, Ohio, Oklahoma, and Texas, as well as to Canada. This is an FDA Class II recall issued by the FDA's Center for Devices and Radiological Health.

The recalled product

Product
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.
Manufacturer
Cordis Corporation
Category
Medical Device — Biliary Stent
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: SF10100SB
  • Lot No. 266586

Distribution

Distributed in 7 states:

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

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Same hazard · stent dislodgement

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