Diamondback Peripheral DBP-CART-125MIC145Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10852528005923), received between Nov 6, 2019 and Jun 4, 2020 — classified as 2 injuries.

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 18, 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.

• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VESSEL SPASM WAS OBSERVED ON IMAGING DURING A PROCEDURE IN WHICH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED. THE SPASM RESOLVED WITHOUT INTERVENTION BY THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10121072 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SEVERELY CALCIFIED, 90% STENOSED LESION IN THE POSTERIOR TIBIAL ARTERY (PT) WAS TREATED WITH A 1.25MM DIAMONDBACK EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) FOLLOWED BY BALLOON ANGIOPLASTY. THE PERONEAL WAS THEN NOTED TO HAVE SLUGGISH FLOW, AND A GUIDE WIRE WAS PLACED AND BALLOON ANGIOPLASTY WAS PERFORMED. AN EMBOLIC FILTER WAS PLACED PROXIMAL TO THE ANTERIOR TIBIAL ARTERY (AT) AND A 2.0MM DIAMONDBACK EXCHANGEABLE CARTRIDGE WAS USED TO TREAT THE 80% STENOSED POPLITEAL AND SUPERFICIAL FEMORAL ARTERIES (SFA) ON LOW, MEDIUM AND HIGH SPEEDS. THE POPLITEAL AND SFA WERE THEN TREATED WITH BALLOON ANGIOPLASTY. THE PATIENT WAS NOTED TO HAVE PULSES VIA ULTRASOUND, BUT THE FOOT APPEARED RED AND MOTTLED. THE LEG OF THE PATIENT FROM FOOT TO MID-THIGH TURNED RED AND BLUE, AND THE PHYSICIAN DIAGNOSED THE PATIENT WITH LIVEDO RETICULARIS POST CARDIAC CATHETERIZATION AND CHOLESTEROL CRYSTAL EMBOLISATION. THE PATIENT WAS PLACED ON A HEPARIN DRIP AND TREATED WITH AN INTEGRIN BOLUS. THE LEG WAS KEPT WARM AND MONITORED OVERNIGHT. THE FOLLOWING MORNING, THE CONDITION HAD MOSTLY RESOLVED AND THE PHYSICIAN EXPECTATION WAS A FULL RECOVERY.

  Patient problems: Embolus; Vascular System (Circulation), Impaired

  MAUDE report 9283984 ↗