Agency classClass IIOur severity:High FDA (Devices)·Z-0218-2022·Announced 2021-11-24

Cordis SMART FLEX Biliary Stent System recalled for potential tip separation

Cordis is recalling the SMART FLEX 6x150 BIL biliary stent system due to potential separation of the distal tip. Approximately 26 units were distributed in the U.S. and Canada. Affected patients should contact their healthcare provider.

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 for a medical device with potential mechanical failure. Since no injuries or illnesses are reported in the source text, it falls under the rubric criterion 'risk-of-harm products where injury has not yet been reported,' resulting in a High severity rating.

Plain-English summary

Cordis Corporation is recalling the SMART FLEX 6x150 BIL biliary stent system, a medical device indicated for use in relieving blockages in the bile duct caused by cancer. The affected units include 26 stents manufactured under lot numbers 266415, 266417, and 266419.

The recall was initiated because of a potential risk that the distal tip (the outer end) of the stent could separate or become dislodged. If this occurs, the stent may no longer function properly and could lead to serious patient complications.

The affected stents were distributed in the United States to California, Florida, Indiana, Louisiana, Ohio, Oklahoma, and Texas, as well as internationally to Canada.

Patients who may have received one of these stents should contact their healthcare provider. Physicians and hospitals should check their records for these lot numbers and take appropriate action for any affected patients.

The recalled product

Product: SMART FLEX 6x150 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
Hazard: distal-tip-separation
device-failure
Affected units: 26

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 (4)

Product Code: SF06150MB
Lot No. 266415
266417
and 266419

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 →

Same manufacturer · Cordis Corporation

See all →

High
SMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement
FDA (Devices) · 2021-11-24
High
SMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement
FDA (Devices) · 2021-11-24
High
SMART FLEX Biliary Stent System Recalled for Potential Distal Tip Dislodgement
FDA (Devices) · 2021-11-24
High
Cordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation
FDA (Devices) · 2021-11-24
High
FDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk
FDA (Devices) · 2021-11-24

Same hazard · distal tip separation