Diamondback Peripheral DBP-EX-150CLA145Recalls & reported problems
Cardiovascular Systems, Inc. · Diamondback Peripheral, Exchangeable Series, 1.50 Classic, 145 cm shaft, 140 krpm High Speed, 90 krpm Medium Speed, 60 krpm Low Speed · Class 2
All models of Diamondback Peripheral (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10852528005909), received between Apr 26, 2021 and Jan 8, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Entrapment of Device” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device2
Patient problems
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2024Entrapment of Device; Entrapment of Device
THE DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO A 3MM. 95% STENOSED AND HEAVILY CALCIFIED MID DISTAL POSTERIOR TIBIAL (PT) AND SPUN ON LOW SPEED AND MEDIUM SPEED FOR TREATMENT. THE OAD DRIVESHAFT WAS ADVANCED THE TOTAL LENGTH AND DURING THE PULL BACK BECAME STUCK. TROUBLESHOOTING STEPS WERE MADE TO FREE THE OAD BUT WERE UNSUCCESSFUL. A GUIDE CATHETER WAS ADVANCED TO ATTEMPT TO FREE THE OAD BUT WAS UNSUCCESSFUL. SURGERY WAS PERFORMED TO REMOVE THE OAD. THE PATIENT WAS STABLE AND DISCHARGED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18463455 ↗InjuryApr 26, 2021Entrapment of Device; Entrapment of Device
OCCLUDED LESIONS IN THE SUPERFICIAL FEMORAL (SFA), POSTERIOR TIBIAL (PT) AND ANTERIOR TIBIAL (AT) ARTERIES WERE CROSSED FROM AN ANTEGRADE APPROACH. THE AT WAS ACCESSED VIA THE PEDAL ARCH AND A DIAMONDBACK PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE PT. GLIDEASSIST WAS USED TO NAVIGATE THE OAD AROUND THE PEDAL ARCH AND TREATMENT WAS PERFORMED IN THE AT. WHEN TREATMENT WITH THE OAD WAS COMPLETED, GLIDEASSIST WAS ACTIVATED TO REMOVE THE DEVICE, HOWEVER IT WAS STUCK IN THE VESSEL. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE DEVICE, BUT THEY WERE UNSUCCESSFUL. CUT DOWN SURGERY WAS PERFORMED TO REMOVE THE DEVICE AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11724969 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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