Diamondback Peripheral DBP-EX-125SOL200Recalls & reported problems
Cardiovascular Systems, Inc. · Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 200 cm shaft, 120 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852528005879), received between Jun 4, 2024 and Jun 4, 2024 — 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. 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
- Material Separation1
- Unexpected Shutdown1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2024Material Separation; Unexpected Shutdown; Material Separation; Unexpected Shutdown
DURING PROCEDURE TO TREAT A LESION IN PROXIMAL ANTERIOR TIBIAL ARTERY, THE DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) STALLED DURING HIGH-SPEED TREATMENT AND FRACTURED BEYOND THE CROWN OF THE OAD RESULTING IN DISSECTION THAT WAS IDENTIFIED THROUGH IMAGING. THE PROCEDURE WAS PERFORMED DISTAL TO PROXIMAL. THE OAD WAS REMOVED, FOLLOWED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND BALLOONING OF THE VESSEL WAS DONE TO COMPLETE THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE DISSECTION OCCURRED DUE TO OAD AND TORTUOSITY OF THE VESSEL.
Patient problems: Vascular Dissection
MAUDE report 19461711 ↗
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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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