SMART FLEX SF06040MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032065914), received between Jun 10, 2023 and Jun 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 10, 2023Crack; Crack

  AS REPORTED, THE PHYSICIAN WAS UNABLE TO DEPLOY THE 6MM X 40 MM 120 CM BILIARY SMART FLEX SES (SELF-EXPANDING STENT) DELIVERY SYSTEM USING PIN AND PULL. THE STENT WAS IN POSITION AND DEPLOYMENT WAS ATTEMPTED FIVE (5) TIMES, BUT THE STENT WOULD NOT DEPLOY; THE OUTER SHEATH WOULD NOT RETRACT. THE PHYSICIAN SAID THE SYSTEM WAS BREAKING WHERE THE TUOHY VALVE MEETS THE SHAFT. THE ENTIRE SYSTEM WAS REMOVED INTACT FROM PATIENT AND THERE WAS NO HARM TO THE PATIENT. ANOTHER SMART CONTROL (6X60) WAS USED AS REPLACEMENT. THE INTENDED PROCEDURE WAS REPORTED TO BE A LEFT SUPERFICIAL FEMORAL ARTERY (SFA) STENTING. VESSEL CHARACTERISTICS INCLUDED MODERATE CALCIFICATION, MILD TORTUOSITY, SEVENTY-FIVE PERCENT STENOSIS, WITH NO ACUTE ANGLE OR BIFURCATION. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE AND NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND THERE WERE NO ANOMALIES NOTED. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102182 ↗

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-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-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-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-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.