SMART FLEX SF07150MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032065617), received between Jul 14, 2023 and Jul 14, 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.

• InjuryJul 14, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, WHEN DEPLOYING THE SMART FLEX 7X150 BIL STENT FROM A PEDAL ACCESS APPROACH IN THE DISTAL SFA, THE SHAFT WAS VERY DIFFICULT TO SLIDE. 75% OF THE STENT DEPLOYED IN THE SFA AND THE OTHER 25% WAS CAUGHT UP IN THE SHAFT AND DRAGGED ACROSS THE POPLITEAL AND TIBIAL VESSELS WHERE IT WAS DEPLOYED. THE DISTAL END OF THE STENT WAS PLACED ACCURATELY IN THE CORRECT AREA BUT DURING DEPLOYMENT THE PROXIMAL PORTION OF THE STENT ELONGATED AND EXCEEDED THE TARGET AREA FOR DEPLOYMENT IN THE LESION. RESISTANCE WAS NOTED DURING DEPLOYMENT. A SECOND STENT WAS NOT USED OR NEEDED TO COVER THE LESION. THE ORIGINAL STENT USED COVERED THE LESION. 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 WAS CLEARLY VISIBLE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE LESION WAS MEASURED TO BE 6MM IN DIAMETER. THE LESION HAD MODERATE CALCIFICATION. THE VESSEL WAS NOTED TO HAVE MODERATE TORTUOSITY. THE LESION HAD A 95% S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325822 ↗

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-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-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-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-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.