SMART FLEX SF08150MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032065624), received between May 10, 2023 and Mar 22, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  AS REPORTED, DURING ATTEMPTED DEPLOYMENT OF AN 8MM X 150MM SMART FLEX BILIARY SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, THE SYSTEM WAS STUCK 1/3RD OF THE WAY DURING UNSHEATHING OF THE STENT. A POPPING NOISE WAS OBSERVED, AND THE STENT WAS PULLED BACK AND STARTED DEPLOYING INTO THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE STENT WAS DEPLOYED WITHOUT ANY OBSERVED DAMAGE OBSERVED VIA FLUOROSCOPY. IT WAS REPORTED THAT THE STENT WAS INTENTIONALLY DEPLOYED BUT WAS IMPLANTED IN AN UNINTENDED LOCATION. THERE WAS SOME DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT AND THE OUTER CATHETER HAD SEPARATED AFTER PULLING ON THE DEVICE TO REMOVE IT. HOWEVER, THE SEPARATED OUTER SHEATH WAS ABLE TO BE REMOVED TOGETHER WITH THE DELIVERY SYSTEM. AN 8MM X 150MM NON-CORDIS SES WAS USED AND WAS DEPLOYED INTO THE INTENDED DISTAL SFA TARGET LESION. THERE WAS NO FOREIGN BODY LEFT WITHIN THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 95% STENOSED LESION WHICH HAD SEVERE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WAS HELD FLAT AND STRAIGHT DURING ITS USE.A6F 45CM NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS USED FOR THIS PROCEDURE. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961481 ↗
• MalfunctionMay 10, 2023Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, WHEN DEPLOYING A SMART FLEX 8MM X150 MM BILIARY STENT, THE SHAFT OF THE DELIVERY SYSTEM "SHEARED OFF"; THE COVERING ON THE STENT SHAFT WAS BUNCHED UP. THERE WAS NO REPORTED PATIENT INJURY. THE ACCESS SITE WAS FEMORAL. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL CHARACTERISTICS AT TARGET SITE INCLUDED CALCIFICATION, NO TORTUOSITY AND NINETY-FIVE PER CENT STENOSIS. THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING NOR DIFFICULTY NOTED DURING PREP. THE GUIDEWIRE WAS PREPPED BEFORE LOADING ON THE DEVICE. THERE WAS NO RESISTANCE WHEN ADVANCING THROUGH THE SHEATH AND NO UNUSUAL FORCE USED DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906792 ↗

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-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-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-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-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-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.