Diamondback Peripheral DBP-EX-175SOL180Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852528005893), received between Aug 19, 2022 and Aug 19, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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

Recent adverse event reports

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

• InjuryAug 19, 2022Mechanical Problem; Mechanical Problem

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A PROXIMAL TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AT 70-80% STENOSIS. ONE TREATMENT WAS COMPLETED AT LOW SPEED AND AN ADDITIONAL TREATMENT AT MEDIUM SPEED. WHEN HIGH SPEED WAS ON, THE OAD STOPPED SPINNING. THE PHYSICIAN PULLED THE OAD OUT, HOWEVER, ONLY HALF OF THE DEVICE WAS REMOVED WHILE THE VIPERWIRE GUIDE WIRE AND CROWN FRAGMENTS REMAINED IN VIVO. A 5MM BALLOON WAS USED TO REMOVE THE CROWN FRAGMENT. THE GUIDE WIRE WAS SUCCESSFULLY ENTRAPPED. THE PROCEDURE WAS ABANDONED AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15259128 ↗