Stealth DBE-200 (REF 70056-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10852528005022), received between Nov 2, 2017 and May 6, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING PRIMING OF THE PERIPHERAL STEALTH ORBITAL ATHERECTOMY DEVICE (OAD), THE OAD WAS NOTED TO BE LEAKING VIPERSLIDE FROM THE STRAIN RELIEF. THE OAD WAS ADVANCED THROUGH THE SHEATH AND BLOOD WAS NOTED TO BE FLOWING BACK THROUGH THE SALINE SHEATH. THE DEVICE WAS REPLACED WITH A SECOND OAD TO COMPLETE THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8583728 ↗
• InjuryNov 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A DISSECTION OCCURRED WHILE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS 90-100% STENOTIC, MODERATELY CALCIFIED AND WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN USED A 6FR GUIDE CATHETER, GLIDEWIRE GUIDE WIRE AND A MINNIE CROSSING CATHETER TO ACCESS THE LESION FROM A CONTRALATERAL APPROACH. THE GLIDEWIRE GUIDE WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE AND THE OAD WAS LOADED ONTO IT. THE PHYSICIAN PERFORMED TWO RUNS AT LOW SPEED WITHOUT ISSUE. DURING THE NEXT RUN AT MEDIUM SPEED, THE OAD BOGGED DOWN AND STOPPED SPINNING. THE OAD WAS REMOVED FROM THE PATIENT AND INSPECTED, BUT NO ISSUES WERE OBSERVED. THE OAD WAS RE-INSERTED INTO THE PATIENT AND THE PHYSICIAN PERFORMED ANOTHER RUN AT LOW SPEED AND AT MEDIUM SPEED. DURING THE RUN AT MEDIUM, THE OAD BOGGED DOWN AGAIN AND STOPPED SPINNING. AT THIS POINT, THE PHYSICIAN DISCOVERED THAT THE OAD WAS STUCK ON THE GUIDE WIRE. THE OAD AND GUIDE WIRE REMOVED AS A UNIT FROM THE PATIENT, BUT POST-ATHERECTOMY ANGIOGRAPHY REVEALED A DISSECTION. THE PHYSICIAN WAS UNABLE TO RECROSS THE LESION WITH A GUIDE WIRE IN ORDER TO COMPL

  Patient problems: Vascular Dissection

  MAUDE report 6995872 ↗