S.M.A.R.T. C06150MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032023693), received between Apr 19, 2018 and Oct 21, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 18, 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.

• MalfunctionOct 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE SMART 6X150 STENT WAS DEPLOYED WITHOUT ISSUES. WHEN THE STENT WAS PULLED OUT OVER THE WIRE, IT WAS NOTED THAT THERE WAS A SECOND INNER CANNULA THAT HAD SEPARATED FROM THE REST OF THE DEVICE. IT WAS RETAINED ON THE WIRE AND IN THE PATIENT. A PIECE OF THE RETAINED CANNULA WAS STICKING OUT OF THE PATIENT, IT WAS THEN REMOVED. THE PHYSICIAN NOTED THERE WAS NO HARM TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; HOWEVER, ONE JPG. IMAGE WAS REVIEWED. A PARTIALLY IDENTIFIED SMART STENT DELIVERY SYSTEM IS CONTAINED WITHIN WHAT APPEARS TO BE THE ORIGINAL PACKAGING, WHICH HAS BEEN OPENED AND USED IN SOME WAY. THERE APPEARS TO BE TWO SEPARATE SHAFTS OR LUMENS PRESENT: THE BLUE OUTER SHEATH AND A BROWN SECONDARY SHAFT. THE STENT IS NOT APPARENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15653154 ↗
• InjuryApr 19, 2018Detachment Of Device Component; Difficult or Delayed Positioning; Detachment Of Device Component; Difficult or Delayed Positioning

  DURING DEPLOYMENT, IT WAS REPORTED THAT THE SMART STENT WAS PARTIALLY DEPLOYED AND THE STENT DELIVERY SYSTEM SEPARATED WHEN AN ATTEMPT WAS MADE TO REMOVE IT FROM THE PATIENT. THE SDS SEPARATED IN THE PATIENT AND THE REMAINING PIECE HAD TO BE SNARED FOR REMOVAL. THERE WAS NO PATIENT INJURY. THE PHYSICIAN WAS DEPLOYING A SMART STENT AND STATED THAT THE STENT BECAME STUCK AND WOULDN'T DEPLOY CORRECTLY. A 6F UNKNOWN SHEATH AND A 0.035 UNKNOWN GUIDEWIRE WAS IN PLACE. THE PHYSICIAN HAD TO FORCEFULLY REMOVE THE STENT AND IT "BROKE OFF". THE PHYSICIAN HAD TO SNARE THE "BROKEN OFF" SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442877 ↗