SMART FLEX SF06150MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032066034), received between Jul 12, 2022 and Apr 28, 2023 — classified as 3 malfunctions.

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

1 FDA recall record name this device's identifier.

6 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.

Recalls naming this device

1. Nov 15, 2017Terminated

   Potential for cracked luer hubs

   Z-0324-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, A 6MM X 150 MM 120 CM BILIARY SMART FLEX SES (SELF-EXPANDING STENT) DELIVERY SYSTEM DID NOT FULLY DEPLOY. THE PULL AND PIN DELIVERY SYSTEM WERE PERFORMED UNTIL THE LAST 20-30MM OF THE PROXIMAL END OF THE STENT, AND IT WOULD NOT DEPLOY FURTHER. THE STENT AND SYSTEM WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. SLIGHT RESISTANCE/FRICTION WAS FELT DURING INSERTION OF THE DEVICE. THE STENT DELIVERY SYSTEM PASSED THROUGH ACUTE BENDS. THE DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS A SLIGHT DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. THE INTENDED PROCEDURE WAS REPORTED TO BE A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. THE TARGET LESION WAS THE SFA WITH NO CALCIFICATION. VESSEL TORTUOSITY WAS DESCRIBED AS "TOUGH" TO GET UP AND OVER THE BIFURCATION. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835808 ↗
• MalfunctionJan 9, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE STENT OF A 6X150 120CM BILIARY SMART FLEX SELF-EXPANDING STENT (SES) DELIVERY SYSTEM OPENED UP BUT COULD NOT BE DEPLOYED AND GOT DISLODGED. ABOUT 1/3 OF THE STENT WAS ABLE TO BE DEPLOYED INSIDE THE PATIENT. AFTER NOT BEING ABLE TO DEPLOY THE STENT ANY FURTHER, THE PHYSICIAN INDICATED HE WAS ABLE TO PULL THE ENTIRE STENT AND CATHETER ASSEMBLY INTO THE 6FR NON-CORDIS SHEATH HE HAD PARKED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THEN, THE ENTIRE SHEATH WAS REMOVED WITH THE STENT INSIDE COMPLETELY OUT OF THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SMART FLEX. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE TEMP INDICATOR DID NOT SHOW ANY UNUSUAL DETAILS AND WAS VISIBLE. THERE WERE ABSOLUTELY NO SIGNS OF FAULTY ON THE DEVICE. WHEN REMOVED FROM THE TRAY, THE STENT WAS INTACT AND COVERED WITH AN OUTER SHEATH. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE LESION WAS NOT CALCIFIED NOR TORTUOUS. THERE WAS NO RESISTANCE/FRICTION DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO CROSS THE LESION. THE STENT FAILED INSIDE THE VESSEL AT THE TARGET AREA WHEN IT WAS DEPLOYED. THE STENT WAS STIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128178 ↗
• MalfunctionJul 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  AS REPORTED, THE SMART FLEX STENT DEPLOYED IN SUCH A WAY THAT IT DID NOT EXPAND. A SABER THAT WILL BE INCLUDED WITH THE STENT WAS THEN USED TO POST DILATE AND THE STENT STUCK ON THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989430 ↗

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-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-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-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-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-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.