Diamondback Peripheral DBP-125SOLID200 (REF 7-10057-05)Recalls & reported problems
Cardiovascular Systems, Inc. · Diamondback Peripheral, Solid Crown, 1.25MM, 200CM shaft, 120 krpm high speed, 90 krpm medium speed, 60 krpm low speed · Class 2
- 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 10850000491219), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Positioning Problem1
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.
InjuryMar 31, 2023Positioning Problem; Positioning Problem
DURING THE ORBITAL ATHERECTOMY PROCEDURE, THE STEALTH 360 ORBITAL ATHERECTOMY DEVICE (OAD) PROLAPSED NEAR THE PATIENT'S HEART WHEN IT WAS INTRODUCED. THE PHYSICIAN RE-OBTAINED ACCESS VIA THE PATIENT'S OTHER ARM RATHER THAN VIA PEDAL ACCESS. A NEW OAD WITH GREATER LENGTH WAS USED AND THE SAME EVENT OCCURRED. UNDER FLUOROSCOPY, IT WAS OBSERVED THE OAD WAS NOT ADVANCING. THE PHYSICIAN OBSERVED THE OAD PROLAPSED IN THE HEART ONCE AGAIN. BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16656799 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.