Diamondback Peripheral DBP-CART-200CLA145Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10850000491028), received between Oct 28, 2020 and Oct 28, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2020Material Separation; Material Separation

  DURING REMOVAL OF THE DIAMONDBACK PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) FOLLOWING A COMPLEX CRITICAL LIMB ISCHEMIA PROCEDURE, RESISTANCE WAS FELT WHEN THE DEVICE ENTERED THE CATHETER TO CROSS THE AORTA. THE DEVICE WAS PULLED, AND THE TIP OF THE OAD FRACTURED. THE HANDLE OF THE OAD WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS CONTINUED. WHEN THE WIRE WAS REMOVED, THE OAD TIP FRAGMENT DISLODGED IN THE RIGHT FEMORAL ARTERY. THE FRAGMENT WAS SECURED TO THE VESSEL WALL USING A STENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10749704 ↗