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Dynamic™ Y Stent 7068Recalls & reported problems

Boston Scientific Corporation · Dynamic™ (Y) Stent · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729764823), received between Aug 15, 2019 and Aug 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Deformation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 15, 2019Material Deformation; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 24, 2019 THAT A DYNAMIC Y STENT WAS TO BE USED IN THE CENTRAL AIRWAY DURING AN AIRWAY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE POSTERIOR MEMBRANE OF THE STENT WAS RIPPED DURING REMOVAL OF THE FORCEPS AND PART OF THE MATERIAL WAS ON THE FORCEPS. THE STENT WAS REMOVED AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8898675 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.