The Recall Desk
HighFDA (Devices)·Z-0219-2022·Announced 2021-11-24

SMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement

Cordis Corporation is recalling SMART FLEX biliary stent systems due to a potential risk that the distal tip may dislodge or separate, which could compromise the stent's function.

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 involving a documented potential failure (distal tip dislodgement or separation) of a critical stent component. No reported incidents or hospitalizations are documented in the source material, and the hazard is theoretical, placing this at the upper bound for recalls without documented injury.

Plain-English summary

The SMART FLEX 8x60 BIL biliary stent system, manufactured by Cordis Corporation, is being recalled due to a potential defect involving the distal tip. The stent tip may dislodge or separate during or after placement in the biliary tract.

This stent is used to palliate blockages caused by malignant strictures in the bile duct system. The affected lot (266523) consists of 4 units that were distributed to healthcare facilities in California, Florida, Indiana, Louisiana, Ohio, Oklahoma, Texas, and Canada.

If the stent tip dislodges, it may no longer function as intended. Healthcare providers and patients with this implant should consult regarding this recall and any necessary follow-up measures.

The recalled product

Product
SMART FLEX 8x60 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 System
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: SF08060SB
  • Lot No. 266523

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

See all →

Same hazard · tip dislodgement

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