Diamondback Peripheral DBP-150CLASS145Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10850000491240), received between Nov 22, 2021 and Aug 18, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2023Material Separation; Material Separation

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE FIRST THIRD OF THE SEVERELY CALCIFIED AND TOTALLY OCCLUDED POSTERIOR TIBIAL ARTERY (TA). FOLLOWING TREATMENT, THE OAD WAS ADVANCED AND THE CROWN BECAME DETACHED FROM THE DRIVESHAFT. THE CROWN BECAME FRACTURED INTO PIECES AND WAS UNABLE TO BE RETRIEVED FROM THE CHRONICALLY OCCLUDED SEGMENT OF THE POSTERIOR TA. NO INTERVENTION WAS PERFORMED. THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17573096 ↗
• InjuryApr 26, 2023Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) CROWN BECAME STUCK IN THE ANTERIOR TIBIAL ARTERY (AT) DURING TREATMENT. THE PHYSICIAN WAS UNABLE TO REMOVE THE OAD. THE OAD DRIVESHAFT AND CROWN FRACTURED, AND APPROXIMATELY 2 CENTIMETERS OF THE DRIVESHAFT REMAINED IN THE AT. PRIOR TO THE PROCEDURE, THE AT WAS COMPLETELY OCCLUDED AND THEREFORE THE PHYSICIAN DID NOT HAVE CONCERNS THAT THE AT WOULD REMAIN OCCLUDED, WITHOUT IMPACT TO FLOW. THE PHYSICIAN PLACED A STENT IN THE SUPERFICIAL FEMORAL ARTERY DOWN TO THE PERONEAL ARTERY. THE PROCEDURE WAS COMPLETE WITHOUT FURTHER COMPLICATIONS. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16818347 ↗
• MalfunctionApr 14, 2023Material Separation; Material Separation

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT THE ANTERIOR TIBIAL ARTERY. FLUOROSCOPY IMAGING WAS PERFORMED DURING A TREATMENT AND IT WAS OBSERVED THAT THE CROWN WAS NOT MOVING WITH THE TIP OF THE DRIVESHAFT. THE OAD WAS REMOVED, AND THE CROWN WAS OBSERVED TO BE MOVING UP AND DOWN THE SHAFT. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743671 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORBITAL ATHERECTOMY WAS SELECTED FOR TREATMENT OF THE LEFT ANTERIOR TIBIAL (AT) AND TIBIOPERONEAL TRUNK (TPT) ARTERIES. THE PROXIMAL AT WAS 70% STENOSED AND THE MID TO DISTAL SEGMENT WAS A STRAIGHT CHRONIC TOTAL OCCLUSION (CTO). THE TPT WAS 90% STENOSED, WITH THE PERONEAL ARTERY PROVIDING COLLATERALS TO THE POSTERIOR TIBIAL ARTERY. SOME DIFFICULTY WAS ENCOUNTERED CROSSING THE AT LESIONS AND THE CTO, BUT THERE WERE NO UNUSUAL TURNS OR BENDS OF THE WIRE AND IMAGING REVEALED THAT THE MICROCATHETER WAS INTRALUMINAL. PROXIMAL TO DISTAL TREATMENT TO THE AT WITH THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS PERFORMED. TREATMENT WAS CONTINUED TO THE CTO ON LOW SPEED, WITH SOME OVERLAPPING TREATMENT. MEDIUM SPEED WAS SELECTED, THE OAD SOUNDED AS THOUGH IT HAD STALLED, AND THE DEVICE HAD BECOME STUCK IN THE VESSEL. THE OAD WAS PULLED BACK THROUGH THE LESION, AND DURING REMOVAL WIRE ACCESS WAS LOST. THE OAD AND WIRE WERE BOTH REMOVED AND IMAGING OF THE CTO REVEALED A VESSEL PERFORATION. ATTEMPTS TO RE-CROSS THE CTO WITH A CATHETER AND NON-CSI WIRE WERE UNSUCCESSFUL. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED TO THE PROXIMAL PORTION OF THE AT AND TPT, FOLLOWING WHICH

  Patient problems: Perforation of Vessels

  MAUDE report 12917036 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED VIA TIBIAL ACCESS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE ANTERIOR TIBIAL ARTERY (AT). INTRAVASCULAR ULTRASOUND SHOWED LUMINAL PLACEMENT. THE PHYSICIAN PLANNED TO WORK FROM THE AT TO THE TIBIOPERONEAL TRUNK (TPT) AND POPLITEAL. ATHERECTOMY WAS PERFORMED ON LOW SPEED FOR A DISTANCE OF ABOUT 15CM. A REST PERIOD WAS THEN OBSERVED. SEVERAL MEDIUM SPEED TREATMENTS WERE THEN ADMINISTERED WITH 25 SECOND REST PERIODS AND WITHOUT ANY COMPLICATIONS. THE OAD WAS REPOSITIONED CLOSER TO THE TPT, AND A LOW SPEED TREATMENT WAS INITIATED. THE CROWN ADVANCED ABOUT 2CM AND CONTINUED TO ORBIT, BUT IT COULD NOT BE ADVANCED ANY FARTHER. THE DRIVESHAFT COULD NOT BE RETRACTED. AFTER SOME MANEUVERING, THE DRIVESHAFT MOVED, BUT IT BECAME ENTRAPPED AGAIN. THE DEVICE WAS THEN EVENTUALLY REMOVED WITH ADDITIONAL FORCE AND WAS RETRACTED BACK TO THE GUIDE CATHETER. IT WAS DETERMINED THE VESSEL HAD SPASMED, THEREBY CAUSING THE MANEUVERING DIFFICULTIES. ALL DEVICES WERE REMOVED FROM THE PATIENT. SOME INTIMAL DAMAGE WAS NOTED ON ANGIOGRAPHY, BUT IVUS CONFIRMED ONLY MINOR DISSECTIONS. BALLOON ANGIOPLASTY WAS USED TO TREAT THE DAMAGE. THE PATIENT WA

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

  MAUDE report 12852017 ↗