Diamondback Peripheral DBP-200CLASS145Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10850000491257), received between May 17, 2021 and Mar 23, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2023Difficult to Remove; Difficult to Remove

  THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE PROFUNDA ARTERY VIA THE BRACHIAL APPROACH. DURING TREATMENT, THE OAD MADE AN UNUSUAL NOISE. THE PHYSICIAN ATTEMPTED TO REMOVE THE OAD, BUT EXPERIENCED RESISTANCE. BECAUSE OF THE RESISTANCE, THE PHYSICIAN DECIDED TO WAIT UNTIL A PRE-SCHEDULED ENDARTERECTOMY TO REMOVE THE OAD. THE OAD WAS SUCESSFULLY REMOVED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600666 ↗
• InjuryMay 17, 2021Material Separation; Material Separation

  WHEN TREATMENT WITH THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS COMPLETED, THE DEVICE WOULD NOT MOVE DURING REMOVAL ATTEMPTS. THE PHYSICIAN PULLED ON THE OAD AND THE CROWN WAS OBSERVED TO DETACH IN THE ANTERIOR TIBIAL ARTERY. THE CROWN WAS REMOVED USING A SNARE AND THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11835308 ↗