The Recall Desk
HighFDA (Devices)·Z-0216-2022·Announced 2021-11-24

FDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk

Cordis Corporation is recalling 9 SMART FLEX 9x60 biliary stent units due to a potential for distal tip dislodgement or separation. The stents were distributed to patients in several U.S. 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 a Class II medical device recall with a theoretical hazard (potential distal tip dislodgement) and no reported illnesses or injuries, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cordis Corporation is recalling 9 units of the SMART FLEX 9x60 BIL 80cm biliary stent system (Product Code SF09060SB, Lot No. 253349). This medical device is indicated for use in the palliation of malignant strictures in the biliary tree.

The FDA has determined there is a potential for distal tip dislodgement or separation of the stent. This malfunction could compromise the device's proper placement and function in the biliary system.

The affected stents were distributed to patients in the United States (California, Florida, Indiana, Louisiana, Ohio, Oklahoma, and Texas) and in Canada. Healthcare facilities and providers who received this specific lot should be aware of the potential hazard.

The recalled product

Product
SMART FLEX 9x60 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
9

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: SF09060SB
  • Lot No. 253349

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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