SMART FLEX SF06100MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032065648), received between Oct 23, 2023 and Oct 23, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 15, 2017Terminated

   Potential for cracked luer hubs

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

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.

• InjuryOct 23, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, DURING DEPLOYMENT OF A 6MM X 100MM 120CM SMART FLEX BILIARY SELF-EXPANDING STENT (SES) DELIVERY SYSTEM, THE PHYSICIAN FULLY LOOSENED THE TOUHY BORST VALVE TO INITIATE STENT DEPLOYMENT. THEIR HANDS WERE PLACED ON THE TOUHY VALVE AND THE METAL PUSH ROD, AND THE STENT DEPLOYMENT WAS PERFORMED VIA THE PIN AND PULL METHOD. THE USER HELD THE HANDLE OF THE DELIVERY SYSTEM FLAT AND STRAIGHT OUTSIDE OF THE PATIENT DURING ATTEMPTED DEPLOYMENT. HOWEVER, RESISTANCE WAS FELT, AND THE PHYSICIAN HAD TO INCREASE THE FORCE OF THE PIN AND PULL WHICH CAUSED THE Y-ADAPTOR TO DISLODGE FROM THE OUTER LAYER OF THE SDS. THE DETACHMENT OF THE TOUHY VALVE MADE THE DEPLOYMENT OF THE STENT DIFFICULT TO PERFORM AND THE STENT WAS PARTIALLY DEPLOYED. THE PHYSICIAN WAS ADVISED TO PULL BACK ON THE SDS TO CONTINUE DEPLOYMENT; HOWEVER, THIS CAUSED THE PARTIALLY DEPLOYED SDS TO MIGRATE PROXIMALLY. THE PHYSICIAN ATTEMPTED TO REMOVE THE PARTIALLY DEPLOYED STENT THROUGH A NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WHILE THE STENT WAS STILL ATTACHED TO THE DELIVERY SYSTEM; HOWEVER, THE REMOVAL WAS UNSUCCESSFUL, AND THE STENT WAS DEPLOYED PROXIMALLY TO ITS INTENDED LOCATION. AS A RESULT, A NEW 6MM X 120MM SM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984743 ↗

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-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-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.
• 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-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.