DIAMONDBACK DBP–EX-200MAX145Recalls & reported problems
Cardiovascular Systems, Inc. · DIAMONDBACK EXCHANGEABLE SYSTEM, 2.00 MAX CROWN, 145CM SHAFT · Class 2
Data updated Oct 13, 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 10850026568476), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Embolism/Embolus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MULTIPLE TREATMENTS WERE PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH THE DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). POST TREATMENT, ANGIOGRAPHIC IMAGING CONFIRMED NO FLOW BELOW THE KNEE. A STENT WAS PLACED AND THEN AN ASPIRATION CATHETER AND TISSUE PLASMINOGEN ACTIVATOR (TPA) WERE USED TO TREAT THE PLAQUE EMBOLISM. FLOW WAS RESTORED IN THE POSTERIOR (PT) AND A PART OF THE PERONEAL ARTERIES BUT NOT IN THE ANTERIOR TIBIAL (AT). THE FOLLOWING DAY, THE PATIENT WAS CONFIRMED TO HAVE PALPABLE PULSES. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Embolism/Embolus
MAUDE report 17487660 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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