Diamondback Peripheral DBP-CART-150CLA145Recalls & reported problems
Cardiovascular Systems, Inc. · Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Clasic, 145 cm shaft, 140krpm High Speed, 90krpm Medium Speed, 60krpm low speed · Class 2
All models of Diamondback Peripheral (33)
Data updated Oct 18, 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 10850000491011), received between Mar 19, 2020 and Mar 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Remains Activated” (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 18, 2026.
Most reported problems
Device problems
- Device Remains Activated1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2020Device Remains Activated; Device Remains Activated
THE DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) SUCCESSFULLY PERFORMED TREATMENT WITH A 2.00MM CLASSIC CROWN CARTRIDGE. THE CARTRIDGE WAS EXCHANGED FOR A 1.50MM CLASSIC CROWN CARTRIDGE. DURING TESTING, THE OAD WOULD NOT TURN OFF WHEN THE POWER BUTTON WAS PUSHED. THE OAD POWER CORD WAS UNPLUGGED AND RE-PLUGGED INTO THE PUMP, AND THE ISSUE RECURRED. THE 1.50MM CARTRIDGE WAS REPLACED WITH THE ORIGINAL 2.00MM CARTRIDGE, AND WHEN TESTED THERE WERE NO ISSUES OBSERVED. THE OAD WAS REPLACED WITH A NON-EXCHANGEABLE DIAMONDBACK OAD TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND NO MAJOR DELAYS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856246 ↗
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- SET Rotarex™S 6 F x 135 cm 80237Straub Medical AG · Catheter, Peripheral, Atherectomy1 recall79 reports
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- Turbo-Elite Laser Atherectomy Catheter 420-006Spectranetics Corporation · Catheter, Peripheral, Atherectomy2 recalls19 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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