The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0324-2018·Announced 2018-01-17

Cordis S.M.A.R.T. Flex Biliary Stent System Recalled for Cracked Luer Hubs

Cordis Corporation is recalling 511 units of the S.M.A.R.T. Flex Biliary Stent System due to a potential for cracked luer hubs.

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: The recall involves a medical device with a structural defect (cracked luer hubs) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cordis Corporation is recalling 511 units of the S.M.A.R.T. Flex Biliary Stent System. The product is indicated for use in the palliation of malignant strictures in the biliary tree. The recall is being conducted because of a potential for cracked luer hubs.

The affected units were distributed worldwide, including nationwide in the United States and in Canada. Specific lot numbers and catalog codes are listed in the official recall documentation.

Healthcare providers and consumers should stop using the affected devices and contact Cordis Corporation for further instructions or a replacement.

The recalled product

Product
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: 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
511

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 (19)

  • 20705032065648 SF06100MB 41318 and 41353
  • 20705032065723 SF06120MB 40997 and 41354
  • 20705032066034 SF06150MB 41198 and 41355
  • 20705032065747 SF07080MB 41319
  • 20705032065655 SF07100MB 40999 and 41199
  • 20705032065617 SF07150MB 41200 and 41356
  • 20705032065662 SF08100MB 41320
  • 20705032066348 SF08120MB 41056
  • 20705032066171 SF09030MB 41055
  • 20705032066164 SF09030SB 41203
  • 20705032066263 SF09060MB 41003 and 41359
  • 20705032065938 SF09060SB 41122
  • 20705032066096 SF09080MB 40998
  • 20705032066072 SF09080SB 41004 and 41202
  • 20705032065778 SF09100SB 40996 and 41124
  • 20705032065570 SF10040SB 41322
  • 20705032065945 SF10060SB 41002
  • 20705032066089 SF10080SB 41323
  • and 20705032066317 SF10100MB 41058.

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Related recalls

Same manufacturer · Cordis Corporation

See all →

Same hazard · structural defect

See all →

Similar recalls