Diamondback Peripheral DBP-150SOLID200 (REF 7-10029-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10852528005367), received between Sep 24, 2018 and Apr 22, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionApr 22, 2020Material Separation; Material Separation

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO PERFORM A PROCEDURE ON (B)(6) 2020. A NON-REPORTABLE ISSUE WAS REPORTED WITH THE OAD. THE PROCEDURE WAS COMPLETED WITH A SECOND OAD. THE DELAY WAS MINIMAL, AND THERE WERE NO PATIENT COMPLICATIONS. UPON COMPLETION OF THE DEVICE ANALYSIS ON (B)(6) 2020, A FILAR FRACTURE WAS IDENTIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9986248 ↗
• MalfunctionSep 24, 2018Fracture; Fracture

  SHORTLY AFTER THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS TURNED ON, AN UNEXPECTED AUDIBLE NOISE WAS HEARD AND THE DEVICE STOPPED SPINNING. THE DEVICE WAS RE-POSITIONED, BUT THE ISSUE RECURRED. UPON REMOVAL FROM THE PATIENT, THE TIP OF THE OAD WAS FOUND TO BE FRAYED AND SHREDDED, AND IT WAS WRAPPED AROUND THE VIPERWIRE. THE PROCEDURE WAS COMPLETED USING A BALLOON ONLY AT NO CONSEQUENCE TO THE PATIENT. THE TIP OF THE OAD WAS NOT PRESENT UPON RECEIPT OF THE OAD FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED REGARDING WHETHER THE TIP COULD HAVE BEEN LEFT BEHIND IN THE PATIENT. THE RESPONSE RECEIVED WAS THAT THE TIP WAS NOT LEFT IN SITU AS CONFIRMED BY FIELD STAFF PRESENT AT THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903574 ↗