SMART FLEX SF10100SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032065785), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K121125); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2023Defective Component; Defective Component

  AS REPORTED, THE MARKERS OF A 10MM X 100MM 80CM BILIARY SMART FLEX SES (SELF-EXPANDING STENT) DELIVERY SYSTEM WERE NOT ABLE TO BE VISUALIZED UNDER FLUOROSCOPY. THE MARKERS WERE NOT MISSING. THE DEVICE DID GO INSIDE THE PATIENT. BECAUSE OF THE INABILITY TO SEE THE MARKERS, THE STENT WAS NOT DEPLOY. THE DEVICE DID GO INSIDE THE PATIENT. A NON-CORDIS STENT WAS USED AS REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY. THE COMPLAINT DEVICE WAS DISCARDED, THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL EVENT DETAILS WERE REQUESTED, HOWEVER, NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121125. One submission often covers many models, so check the product and lot details in each record.

• Z-0220-2022 · Oct 1, 2021 · Open, Classified
  SMART FLEX 10x100 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.
• Z-0221-2022 · Oct 1, 2021 · Open, Classified
  SMART FLEX 10x100 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.
• Z-0217-2022 · Oct 1, 2021 · Open, Classified
  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.
• Z-0219-2022 · Oct 1, 2021 · Open, Classified
  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.
• Z-0216-2022 · Oct 1, 2021 · Open, Classified
  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.
• Z-0218-2022 · Oct 1, 2021 · Open, Classified
  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.
• Z-0324-2018 · Nov 15, 2017 · Terminated
  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.