Diamondback Peripheral DBP-CART-125SOL200Recalls & reported problems
Cardiovascular Systems, Inc. · Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 200 cm shaft, 120krpm High Speed, 90krpm Medium Speed, 60krpm 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 10852528005985), received between Oct 23, 2020 and Oct 23, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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.
Most reported problems
Device problems
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2020Entrapment of Device; Entrapment of Device
A DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF THE PERONEAL ARTERY AND TIBIOPERONEAL TRUNK. THE OAD WAS BEING POSITIONED USING GLIDEASSIST MODE. THE GUIDE WIRE WAS RELEASED WHILE THE OAD WAS BEING ADVANCED, AND THE OAD BECAME STUCK IN A COLLATERAL VESSEL. ATTEMPTS WERE PERFORMED WITH MULTIPLE TECHNIQUES TO PULL THE OAD BACK, BUT NONE WERE SUCCESSFUL. THE PERONEAL ARTERY WAS OPEN WITH PALPABLE PULSES. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO THE OPERATING ROOM FOR REMOVAL. THE SITE DECLINED TO PROVIDE SURGERY DETAILS. ON (B)(6) 2020, THE PATIENT RETURNED, AND THE ANTERIOR TIBIAL AND POSTERIOR TIBIAL ARTERIES WERE OPENED. IMAGING DID NOT SHOW ANY SIGN OF A CSI DEVICE IN THE PATIENT, SO THE REMOVAL SURGERY WAS ASSUMED TO BE SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10730379 ↗
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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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