DESTINATION 54-86501Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00389701009438), received between Mar 8, 2021 and Apr 29, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT WHEN THE DESTINATION WAS EXTRACTED FROM THE PACKAGE IT APPEARED CRUSHED. ADDITIONAL INFORMATION WAS RECEIVED ON 15APRIL2021: THEY RESOLVED THE ISSUE WITH THE DEVICE, TO CONTINUE THE PROCEDURE BY USING A SECOND DEVICE. THE PACKAGING WAS NOT DAMAGED. THE PATIENT'S HEALTH WAS NOT AFFECTED, THE DEVICE DID NOT GET TO TOUCH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749040 ↗
• MalfunctionApr 29, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION DESILET FOLDED, WHICH MADE IT IMPOSSIBLE TO MOUNT THE DILATOR. THIS HAPPENED WITH TWO DEVICES FROM THIS LOT. A TOTAL OF THREE DEVICES WERE USED FOR THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745199 ↗
• MalfunctionApr 29, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION DESILET FOLDED, WHICH MADE IT IMPOSSIBLE TO MOUNT THE DILATOR. THIS HAPPENED WITH TWO DEVICES FROM THIS LOT. A TOTAL OF THREE DEVICES WERE USED FOR THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745197 ↗
• MalfunctionMar 8, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THERE WAS DIFFICULTY PLACING THE DESTINATION DILATOR INTO THE SHEATH. UPON INSPECTION IT WAS NOTED THAT PART OF THE SHEATH MIDWAY WAS CRUSHED. SURGEONS PUT THE SHEATH ASIDE FOR RETURN. THERE WERE NO ISSUES WITH THE REPLACEMENT SHEATH. THE VASCULAR SURGERY PROCEDURE WAS N ATHERECTOMY AND STENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA). ADDITIONAL INFORMATION WAS RECEIVED ON 15FEB2021. THE CUSTOMER SWAPPED OUT TO A NEW TERUMO DESTINATION SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440464 ↗