Diamondback Peripheral DBP-EX-HANDLERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10850000491035), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, A DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) HANDLE WAS USED TO TREAT AN 8-10 CENTIMETER LONG LESION IN THE LEFT MID-ANTERIOR TIBIAL (AT) ARTERY. TWO CARTRIDGES WERE USED WITH THE OAD HANDLE. DURING THE PROCEDURE, THE AT SHUT DOWN DUE TO POTENTIAL EMBOLIZATION, AND BLOOD FLOW WAS LIMITED. HOWEVER, AN EMBOLIZATION WAS NOT CONCLUSIVELY CONFIRMED. IT WAS NOTED THAT NO MALFUNCTION WITH THE DEVICES WERE NOTED, AND THE CAUSE OF THE POTENTIAL EMBOLIZATION AND NO FLOW WAS NOT DETERMINED. THE PATIENT WAS HELD IN THE HOSPITAL OVERNIGHT FOR EVALUATION AND POTENTIAL MEDICATION THERAPY.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 9727160 ↗