Stealth DBE-200 (REF 7-10059-09)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10850000491349), received between Oct 6, 2020 and Sep 25, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A 6FR SHEATH TO DORSALIS PEDIS FOR PEDAL ACCESS WAS GAINED AND A 2.0 CLASSIC DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO 90% STENOSED, HEAVILY CALCIFIED, NON TORTUOUS PROXIMAL ANTERIOR TIBIAL (AT) FOR TREATMENT. THE VESSEL DIAMETER WAS 3.5 MM. THE SOUND OF DEVICE BOGGING DOWN WAS HEARD AND WHEN THE PHYSICIAN PULLED THE OAD, IT WAS UNSUCCESSFUL. SEVERAL ATTEMPTS WERE MADE TO PULL IT OUT, BUT IT WAS UNABLE TO REMOVE THE OAD. THE CATHETER WAS CUT OFF THE DEVICE AND ATTEMPTED TO REMOVE AGAIN, BUT IT FAILED. AFTER SEVERAL MORE ATTEMPTS, THE CATHETER SEPARATED AND AN ATTEMPT WAS MADE TO SNARE THE CROWN OUT, BUT WAS UNSUCCESSFUL. THE CROWN WAS STUCK IN DISTAL ANTERIOR TIBIAL ARTERY AND A STENT WAS PLACED OVER THE CROWN TO KEEP IT IN PLACE. IT IS UNKNOWN WHY THE OAD WAS STUCK. THE PATIENT WAS DISCHARGED THE SAME DAY AND WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23144867 ↗
• InjuryJan 22, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  A 2.0 CLASSIC STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY (CFA) AND LEFT POPLITEAL ARTERIES. LOW SPEED, MEDIUM SPEED, AND HIGH SPEED TREATMENTS WERE SUCCESSFUL IN THE CFA. WHEN ATTEMPTING TO TREAT THE POPLITEAL ARTERY, THE DEVICE DID NOT SPIN. THE CONTROL KNOB WAS MOVED FULLY BACK AND IT WAS OBSERVED THE CROWN WAS NOT MOVING WITH THE CONTROL KNOB. DURING REMOVAL, FORCE WAS REQUIRED TO REMOVE THE CROWN FROM THE LESION WHICH RESULTED IN THE CROWN BECOMING DETACHED. SEVERAL ANGIOGRAMS WERE TAKEN AND THE CONCLUSION WAS MADE THAT THE WIRE HAD ENTERED INTO A SMALL SIDE BRANCH IN THE PATIENTS DISTAL POPLITEAL AREA WHICH CAUSED THE CROWN OF THE OAD TO BECOME STUCK IN THE PATIENTS SMALL SIDE BRANCH ARTERY. THE CROWN REMAINED IN VIVO. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED IN THE POPLITEAL ARTERY. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21211061 ↗
• InjuryAug 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  FOLLOWING THE SECOND TREATMENT, A HOLE WAS OBSERVED ON THE SALINE SHEATH OF THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BETWEEN THE DISTAL AND PROXIMAL END OF THE CATHETER. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE. IN THE PHYSICIAN'S OPINION, THE FLOW OF SALINE SOLUTION WAS SUFFICIENT TO AVOID PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613082 ↗
• InjurySep 12, 2022Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  A STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS SPUN OVER A NON-CSI WIRE IN THE POPLITEAL ARTERY. THE CROWN DID NOT ENGAGE IN THE ONE TO ONE MOTION INSIDE THE DISTAL SUPERIOR FEMORAL ARTERY AND POPLITEAL ARTERY. THE OAD WAS REMOVED AND THE WIRE WAS NOTED TO BE FRACTURED WITH THE DISTAL PORTION OF THE NON-CSI WIRE IN VIVO. AN ATTEMPT WAS MADE TO RETRIEVE THE FRACTURED COMPONENT, HOWEVER, WAS UNSUCCESSFUL. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15406415 ↗
• MalfunctionMar 29, 2021Material Separation; Material Separation

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS UNABLE TO ADVANCE TO THROUGH THE VESSEL AND THE PROCEDURE WAS COMPLETED WITH A SMALLER SIZED CROWN. UPON RECEIPT OF THE OAD FOR ANALYSIS, THE CROWN WAS FOUND TO BE DETACHED. PER CSI FIELD STAFF, THERE WERE NO FRAGMENTS LEFT IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580873 ↗
• MalfunctionOct 6, 2020Material Separation; Material Separation

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED, AND THE VESSEL WAS 6 MM IN DIAMETER WITH NO TORTUOSITY. THE OAD LOOKED ODD, BUT TREATMENT CONTINUED AND THE OAD WAS INSERTED INTO THE PATIENT. THE CROWN WAS DIFFICULT TO SEE UNDER FLUOROSCOPY. THE OAD WAS REMOVED FROM THE PATIENT, AND A SHARP ANGLE WHERE THE CROWN WOULD HAVE BEEN LOCATED WAS OBSERVED. UPON EXAMINATION, THE CROWN DID NOT APPEAR TO BE ATTACHED TO THE DRIVESHAFT. IT WAS NOT KNOWN WHEN THE CROWN BECAME DETACHED FROM THE DRIVESHAFT OR IF IT WAS ATTACHED PRIOR TO INTRODUCTION TO THE PATIENT. IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED IN THE PATIENT. THE OAD WAS UNABLE TO BE RE-ADVANCED ON THE GUIDE WIRE. A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10636879 ↗