The Recall Desk
HighFDA (Devices)·Z-0217-2022·Announced 2021-11-24

SMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement

Cordis Corporation is recalling 3 units of SMART FLEX 6x120 BIL biliary stents due to a potential for distal tip dislodgement or separation. No illnesses or injuries have been reported.

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 a risk-of-harm medical device where injury has not yet been reported. While the potential for distal tip dislodgement could cause serious complications in biliary function, no illnesses or injuries have been documented, placing this at the 'High' level per the rubric.

Plain-English summary

Cordis Corporation is recalling 3 units of the SMART FLEX 6x120 BIL (120cm) Biliary Stent System (Lot No. 266401) due to a potential for distal tip dislodgement or separation. The stent system is used to treat malignant strictures in the biliary tree.

Affected units were distributed to California, Florida, Indiana, Louisiana, Ohio, Oklahoma, Texas, and Canada. No illnesses or injuries have been reported.

Healthcare providers and patients who have received this stent should contact Cordis Corporation or consult with their medical team regarding the recall and appropriate follow-up care.

The recalled product

Product
SMART FLEX 6x120 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
Category
Medical Device — Biliary Stent System
Hazard
  • tip-dislodgement
  • device-failure

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: SF06120MB
  • Lot No. 266401

Distribution

Distributed in 7 states:

  • CA
  • FL
  • IN
  • LA
  • OH
  • OK
  • TX

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