DIAMONDBACK DBP-200MAX145Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10850026568445), received between Mar 29, 2023 and Aug 1, 2025 — classified as 1 death, 1 injury, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) PACKAGING WAS OBSERVED TO BE OPEN WHEN IT WAS TAKEN OFF THE SHELF BY STAFF FOR A PROCEDURE. A NOTE WAS ON THE BOX INDICATING THE PACKAGING WAS OPENED. IT WAS UNKNOWN WHY THE PACKAGING WAS OPENED. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689263 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT TWO LESIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH ONE LOW SPEED TREATMENT AND ONE HIGH SPEED TREATMENT. A LESION IN THE POPLITEAL ARTERY (PA) WAS TREATED WITH ONE LOW SPEED TREATMENT. A NON-CSI BALLOON WAS USED TO COMPLETE TREATMENT IN THE SFA AND PA. POST TREATMENT, ANGIOGRAPHIC IMAGING REVEALED SLOW FLOW THROUGH THE SFA AND PA. THE PHYSICIAN SUSPECTED EMBOLIZATION OF THE ANTERIOR TIBIAL ARTERY AND POSTERIOR TIBIAL ARTERY. INTRA-ARTERIAL NITROGLYCERIN (NTG) WAS ADMINISTERED; HOWEVER, EMBOLIZATION WAS SUSPECTED TO STILL BE UNRESOLVED. HEPARIN WAS ADMINISTERED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A NON-CSI BALLOON WAS USED TO TREAT THE AT AND PT. ADDITIONAL NTG WAS ADMINISTERED, AND FLOW WAS IMPROVED. A STENT WAS PLACED IN THE TPT. THE PATIENT WAS TRANSFERRED TO POST PROCEDURE CARE FOR RECOVERY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Embolism/Embolus

  MAUDE report 16989184 ↗
• DeathApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT A LESION IN THE ILIAC ARTERY. FOLLOWING A HIGH SPEED TREATMENT, THE PATIENT EXPERIENCED SEVERE PAIN. THE OAD WAS REMOVED AND A PERFORATION WAS OBSERVED VIA CONTRAST. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED. THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT WAS INTUBATED AND WAS HOSPITALIZED. THE PATIENT EXPIRED.

  Patient problems: Cardiac Arrest; Pain; Perforation of Vessels

  MAUDE report 16745630 ↗
• MalfunctionMar 29, 2023Material Separation; Material Separation

  THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO PERFORM ONE LOW SPEED TREATMENT AND TWO HIGH SPEED TREATMENTS. DURING THE THIRD TREATMENT, IT WAS NOTICED THE DRIVESHAFT TIP WAS NOT COMING BACK WITH THE CROWN. THE OAD WAS REMOVED, AND IT WAS NOTED THE TIP HAD DETACHED FROM THE OAD. THE FRACTURED TIP WAS RETRIEVED VIA WIRE PULL BACK. BALLOON ANGIOPLASTY WAS PERFORMED, AND A STENT WAS PLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16638170 ↗