SMART FLEX SF05040MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032066249), received between Oct 18, 2022 and Apr 7, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 5X40 SMART FLEX BIL WAS REMOVED FROM PACKAGING AND FOUND TO HAVE PART OF THE STENT ALREADY PARTIALLY DEPLOYED/STICKING OUT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGED NOTED TO THE PRODUCT PACKAGING. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704801 ↗
• InjuryOct 18, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE SMART FLEX 5X40 DELIVERY SYSTEM DID NOT DE-SHEATH THE STENT CORRECTLY, THE STENT BEGINS TO FLOWER OPEN AND THEN STOPS. IT WAS NOT A SMOOTH DELIVERY OR SHOWING ITS FULLY DEPLOYED RADIOGRAPHICALLY WHILE STENT DEPLOYMENT STENTS HAVE BEEN FINISHED. THE STENT HAD PARTIALLY DEPLOYED DISTALLY AT FIRST. THE STENT WAS FULLY DEPLOYED/OPENED AFTER PIN AND PULL PROCESS. AFTER MANY SECONDS, THE STENT FULLY DEPLOYED/OPENED BUT IT WAS NOT WHERE IT WAS SUPPOSED TO BE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INJURY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH AFTER BEING REMOVED FROM THE TRAY. THE STOPCOCK WAS NOT CONNECTED TO THE Y-CONNECTOR OF THE TUOHY BORST VALVE. THERE WAS NO DIFFICULTY WHILE FLUSHING THE SDS. THE TARGET LESION DIAMETER WAS MEASURED TO BE 4MM. THE LES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621783 ↗

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-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-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-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-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-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-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-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.