Stealth DBE-150 (REF 7-10059-08)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10850000491332), received between Oct 19, 2020 and Jun 1, 2026 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Entrapment of Device

  IT WAS REPORTED A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT LESIONS IN THE DISTAL POPLITEAL AND PROXIMAL PERONEAL ARTERY. ONE LOW SPEED TREATMENT, FOLLOWED BY TWO MEDIUM SPEED TREATMENTS WERE PERFORMED IN THE POPLITEAL ARTERY, AND TWO LOW SPEED TREATMENTS WERE PERFORMED IN THE PERONEAL ARTERY. AS THE PHYSICIAN WAS REMOVING THE OAD BY BRINGING THE OAD CONTROL KNOB BACK TO THE START POSITION, THE OAD GOT CAUGHT IN TISSUE, AND POSSIBLY WRAPPED IN TISSUE. THE PHYSICIAN WAS UNABLE TO REMOVE THE OAD. THE VIPERWIRE GUIDE WIRE WAS ABLE TO MOVE FREELY. A NEW ACCESS SITE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND AN UNSPECIFIED BALLOON WERE USED TO HELP THE OAD CROWN GET UNWEDGED, HOWEVER, THIS WAS UNSUCCESSFUL. THE PHYSICIAN HAD TO USE FORCE TO PULL THE OAD OUT SUCCESSFULLY. AN ESPRIT STENT WAS PLACED WHERE THE OAD CROWN CAUSED A DISSECTION/REMOVED TISSUE FROM THE PERONEAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 25355123 ↗
• MalfunctionDec 12, 2025Break; Material Separation; Stretched; Break; Material Separation; Stretched

  IT WAS REPORTED THAT DURING SETUP THE STRAIN RELIEF OF THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) SEPARATED FROM THE OAD. IT WAS UNKNOWN WHAT CAUSED THE DAMAGE. THE OAD WAS LOADED ONTO A VIPERWIRE ADVANCE GUIDE WIRE THAT WAS IN VIVO AT THE TIME OF EVENT. ADDITIONALLY, THE OAD DRIVESHAFT WAS STRETCHED AND THE CROWN BROKE OFF IN THE SHEATH. THE SHEATH WAS REMOVED QUICKLY FROM THE PATIENT, ALONG WITH THE CROWN INSIDE. THE OAD WAS REPLACED TO COMPLETE THE PROCEDURE. MANUAL PRESSURE WAS APPLIED FOR HEMOSTASIS AS NO CLOSURE DEVICE WAS UTILIZED IN THE LABORATORY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789748 ↗
• MalfunctionMay 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE CROWN OF THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DISLODGED FROM THE DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035270 ↗
• MalfunctionApr 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE CROWN OF THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS NOT MOVING RELATIVE TO THE OAD DRIVESHAFT DURING TREATMENT OF LESION IN PERONEAL ARTERY THROUGH FEMORAL IPSILATERAL APPROACH. THE LESION WAS CALCIFIED AND 100% STENOSED. IT WAS OBSERVED THE CROWN HAD COME OFF OF THE DRIVESHAFT WHICH REMAINED INTACT. FOLLOWING PLANNED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH AN UNSPECIFIED BALLOON, THE DETACHED CROWN WAS FOUND ON THE BALLOON UPON BALLOON REMOVAL FROM PATIENT. THE OAD WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21841760 ↗
• InjuryAug 13, 2024Entrapment of Device; Material Separation; Noise, Audible; Unexpected Shutdown; Entrapment of Device; Material Separation; Noise, Audible; Unexpected Shutdown

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF LESION IN DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) VIA RIGHT COMMON FEMORAL ARTERY (CFA) APPROACH. THE VESSEL DIAMETER WAS 5-6MM. A 5FR GUIDING SHEATH WAS ADVANCED BUT REPLACED WITH 6FR 45 CM GUIDING SHEATH FOR LONGER ACCESS AND STABILITY. USING THE 6FR GUIDING SHEATH FOR SUPPORT, A .014 NON-CSI GUIDE WIRE WAS USED TO CROSS THE LESION. THE 6 FR SHEATH WAS EXCHANGED WITH .014 CATHETER. THE GUIDE WIRE WAS REPLACED WITH VIPERWIRE AND THE OAD WAS SUCCESSFULLY ADVANCED TO THE DISTAL SFA. FOLLOWING THE SECOND ATHERECTOMY TREATMENT IN DISTAL SFA WHICH WAS ON MEDIUM SPEED, THE LESION WAS ENGAGED, AND A HIGH-PITCH NOISE WAS HEARD. THE OAD STOPPED SPINNING, BUT THE OAD LED LIGHTS REMAINED LIT. THE PHYSICIAN STARTED TO REMOVE THE OAD, BUT OBSERVED UNDER FLUOROSCOPY THAT THE CROWN HAS FRACTURED AND WAS STUCK IN DISTAL SFA. IT IS UNKNOWN IF THE DETACHMENT OCCURRED WHILE PULLING THE OAD FOR REMOVAL. A 2.0 X 540 BALLOON OF UNKNOWN BRAND WAS USED TO SUCCESSFULLY SNARE THE DETACHED CROWN. UPON REMOVAL, THE BALLOON WAS FOUND STUCK ON THE FRACTURED COMPONENT. NO FRACTURED COMPONENT WAS LEFT IN VIVO. BALLOON ANGIOPLASTY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978075 ↗
• InjuryMar 25, 2024Material Separation; Material Separation

  DURING THE PROCEDURE, THE CROWN ON THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DETACHED. THE COMPONENTS WERE RETRIEVED. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18969625 ↗
• MalfunctionJun 20, 2023Leak/Splash; Leak/Splash

  FOLLOWING TREATMENT AND REMOVAL OF THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), LEAKING FLUID WAS OBSERVED AT THE OAD SHEATH. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165833 ↗
• MalfunctionMar 31, 2023Detachment of Device or Device Component; Improper Flow or Infusion; Detachment of Device or Device Component; Improper Flow or Infusion

  A STEALTH 360 ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE POPLITEAL ARTERY AND ANTERIOR TIBIAL ARTERY VIA ANTEGRADE. DURING REMOVAL OF THE OAD, THE STRAIN RELIEF BECAME DETACHED FROM THE OAD HANDLE. THE VIPERSLIDE SOLUTION WAS LEAKING OUT OF THE OAD NOSE AND NEAR THE END OF THE DRIVESHAFT. WHEN THE OAD WAS REMOVED, BLOOD WAS OBSERVED IN THE SALINE TUBING. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656013 ↗
• MalfunctionNov 16, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  THE SALINE SHEATH OF THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS OBSERVED TO BE DAMAGED UPON REMOVAL OF THE OAD AT THE END OF THE PROCEDURE. SALINE FLUID WAS LEAKING OUTSIDE OF THE STERILE FIELD. IT WAS INDICATED THERE WAS ENOUGH SALINE ENCAPSULATED IN THE SYSTEM TO ALLOW FOR SMOOTH REMOVAL. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808831 ↗
• MalfunctionAug 31, 2022Break; Break

  THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO THE SUPERFICIAL FEMORAL ARTERY WHERE A PROXIMAL OCCLUSION WAS TREATED. THE OAD COULD NOT ADVANCE FURTHER OVER A TORTUOUS ILIAC BIFURCATION. THE OAD WAS REMOVED AND REPLACED. WHEN THE DEVICE WAS REMOVED, THE MID/DISTAL PORTION OF THE SALINE SHAFT WAS NOTED TO BE DAMAGED. THE FLOW OF SALINE TO THE TIP OF THE OAD WAS CONSIDERED SUFFICIENT TO AVOID PATIENT INJURY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327767 ↗
• MalfunctionAug 4, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  WHILE PREPARING THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) TO REENTER THE PATIENT FOR A SECOND TREATMENT, THE USER NOTED A PINHOLE LEAK LOCATED NEAR THE MID SHAFT OF THE SALINE SHEATH. THE FLOW OF THE SALINE TO THE TIP OF THE OAD WAS CONSIDERED SUFFICIENT TO AVOID INJURY TO THE PATIENT, HOWEVER, A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165008 ↗
• InjuryJul 1, 2022Material Separation; Material Separation

  A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED VIA GROIN ACCESS FOR TREATMENT OF LESIONS IN THE RIGHT COMMON FEMORAL ARTERY (CFA), SUPERFICIAL FEMORAL ARTERY (SFA), AND POPLITEAL ARTERY. THE DISTAL SFA LESION WAS TREATED ON LOW, MEDIUM, AND HIGH SPEED. THE POPLITEAL LESION, WHICH WAS A CHRONIC TOTAL OCCLUSION, WAS TREATED ON LOW AND MEDIUM SPEED THEREAFTER. THE CFA WAS TREATED ON LOW, MEDIUM, AND HIGH SPEED. THE CROWN DETACHED FROM THE DRIVESHAFT DURING THE FINAL TREATMENT IN THE CFA AND MIGRATED TO A COLLATERAL VESSEL. THIS WAS OBSERVED ON IMAGING AFTER THE OAD HAD BEEN REMOVED. MULTIPLE UNSUCCESSFUL ATTEMPTS TO RETRIEVE THE CROWN WITH A SNARE WERE MADE. THE CROWN WAS ABANDONED IN VIVO.

  Patient problems: Foreign Body In Patient

  MAUDE report 14885336 ↗
• InjuryMay 26, 2021Entrapment of Device; Entrapment of Device

  THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) STOPPED SPINNING FOLLOWING TREATMENT. DURING REMOVAL OF THE OAD, THE CROWN BECAME STUCK ON A STENT IN THE POPLITEAL ARTERY. PEDAL ACCESS WAS GAINED, AND THE CROWN WAS ADVANCED THROUGH THE PEDAL SHEATH. THE CROWN WAS THEN CUT, AND THE REMAINDER OF THE DRIVESHAFT WAS PULLED BACK THROUGH THE INITIAL ACCESS SHEATH. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887221 ↗
• InjuryMar 26, 2021Material Separation; Material Separation

  A STEALTH GEN2 PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS SELECTED FOR TREATMENT OF A 99% STENOSED, SEVERELY CALCIFIED LESION IN THE MID TO DISTAL ANTERIOR TIBIAL ARTERY. THE ARTERY WAS NOT TORTUOUS AND 2.0MM IN DIAMETER. TREATMENT WAS STARTED ON LOW SPEED, HOWEVER, THE OAD DID NOT PASS THROUGH THE LESION. MEDIUM SPEED WAS SELECTED, AND ADDITIONAL FORCE WAS APPLIED. THE CROWN STAYED IN PLACE PROXIMAL TO THE LESION, HOWEVER, THE DISTAL TIP OF THE DRIVESHAFT ADVANCE THROUGH THE LESION. THE CROWN WAS OBSERVED TO BE DETACHED. A BALLOON WAS INFLATED TO 2 ATMS AND USED TO RETRIEVE THE CROWN FROM THE VESSEL. ADDITIONAL BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE PROCEDURE FOR A GOOD RESULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11575479 ↗
• MalfunctionOct 27, 2020Device Remains Activated; Device Remains Activated

  ORBITAL ATHERECTOMY TREATMENT WITH A STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR A LONG DIFFUSELY DISEASED RIGHT SUPERFICIAL FEMORAL, POPLITEAL TIBIAL AND TIBIOPERONEAL TRUNK ARTERIES. SEVERAL TREATMENTS WERE ADMINISTERED ON EACH SPEED IN THE FIRST TWO LESIONS. THE OAD WAS ADVANCED TO THE THIRD LESION, HOWEVER THE OAD DID NOT SPIN WHEN PROMPTED. DESPITE TROUBLESHOOTING, THE ISSUE RECURRED. THE OAD WAS REMOVED AND REPLACED WITH A SECOND DEVICE TO CONTINUE TREATMENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. ADDITIONAL EX VIVO TESTING WAS PERFORMED, AND THE OAD SPUN. HOWEVER, IT WOULD NOT STOP SPINNING UNTIL THE BRAKE WAS UNLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741838 ↗
• InjuryOct 19, 2020Entrapment of Device; Entrapment of Device

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A CHRONIC TOTAL OCCLUSION IN THE MID AND PROXIMAL ANTERIOR TIBIAL ARTERY (AT). DURING TREATMENT, AN AUDIBLE INCREASE IN PITCH WAS NOTED. THE OAD WAS STOPPED AND AN ATTEMPT WAS MADE TO REMOVE THE DEVICE, HOWEVER THE CROWN WAS STUCK IN THE VESSEL. SEVERAL ATTEMPTS WERE REQUIRED TO REMOVE THE DEVICE VIA PULLING, AND AN ANGIOGRAM FOLLOWING REMOVAL SHOWED A SMALL PERFORATION. MULTIPLE BALLOON INFLATIONS WERE PERFORMED AND HEPARIN WAS ADMINISTERED OVER A 25-30 MINUTE PERIOD TO RESOLVE THE PERFORATION. THE TIP OF THE OAD APPEARED DAMAGED FOLLOWING REMOVAL. THE PATIENT WAS DISCHARGED AND WAS MONITORED OVER THE FOLLOWING 72 HOURS. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 10701575 ↗