Diamondback Peripheral DBP-125SOLID200 (REF 7-10029-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852528005350), received between Feb 27, 2020 and Feb 27, 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. 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 27, 2020Material Separation; Material Separation

  DURING A PROCEDURE, THE DOOR OF THE OAS PUMP OPENED INDEPENDENTLY, AND THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) POWERED OFF MID-TREATMENT. IT WAS IDENTIFIED THAT THE SALINE TUBING IN THE PUMP DOOR HAD BEEN PINCHED, AND WAS LEAKING FLUID. THE OAD WAS REMOVED FROM THE PATIENT, AND IT WAS REVEALED THAT THE DRIVESHAFT SHEATH HAD FRACTURED OFF NEAR THE CROWN. THE FRAGMENT REMAINED ON THE DRIVESHAFT OF THE OAD, AND THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THE OAD WAS REPLACED WITH THE SECOND OAD TO COMPLETE THE PROCEDURE. BALLOON ANGIOPLASTY WAS PERFORMED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 9765905 ↗