StealthRecalls & reported problems across all models

We found 17 models of Stealth by Cardiovascular Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 225 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2015 and Sep 18, 2026 — classified as 1 death, 155 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (68 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Stealth problems

Stealth models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Stealth PRD-SC30-MICRO

  Catheter, Peripheral, Atherectomy
  1 death56 reports
• Stealth PRD-SC30-125

  Catheter, Peripheral, Atherectomy
  27 reports
• Stealth PRD-SC30-200

  Catheter, Peripheral, Atherectomy
  26 reports
• Stealth PRD-SC30-200

  Catheter, Peripheral, Atherectomy
  24 reports
• Stealth PRD-SC30-150

  Catheter, Peripheral, Atherectomy
  16 reports
• Stealth DBE-150

  Catheter, Peripheral, Atherectomy
  16 reports
• Stealth PRD-SC30-150

  Catheter, Peripheral, Atherectomy
  16 reports
• Stealth PRD-SC30-125

  Catheter, Peripheral, Atherectomy
  14 reports
• STEALTH PRD-MAX-200

  Catheter, Peripheral, Atherectomy
  7 reports
• Stealth DBE-200

  Catheter, Peripheral, Atherectomy
  6 reports
• Stealth DBE-150

  Catheter, Peripheral, Atherectomy
  5 reports
• Stealth RAD-SC30-150

  Catheter, Peripheral, Atherectomy
  3 reports
• Stealth RAD-SC30-175

  Catheter, Peripheral, Atherectomy
  3 reports
• Stealth RAD-SC30-175

  Catheter, Peripheral, Atherectomy
  2 reports
• Stealth DBE-200

  Catheter, Peripheral, Atherectomy
  2 reports
• Stealth RAD-SC30-125

  Catheter, Peripheral, Atherectomy
  1 report
• Stealth RAD-SC30-150

  Catheter, Peripheral, Atherectomy
  1 report

Recent Stealth adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825007 ↗
• InjuryJul 30, 2026Entrapment of Device

  It was reported that the procedure was to treat mildly calcified, mildly tortuous lesion in anterior tibial artery (AT) through common femoral artery access. The vessel diameter was unknown as no intravascular ultrasound (IVUS) was used. During treatment, the crown of the 1.25 solid Stealth 360 Peripheral Orbital Atherectomy Device (OAD) became stuck at the midpoint of the artery. Additional nitroglycerin beyond standard of care was administered, the OAD was turned off/on several times, and the OAD was removed from the patient. The OAD was intact and had no tissue/plaque. The procedure was completed without using other devices. There was no clinically significant delay in procedure and no adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090293 ↗
• InjuryJul 1, 2026Entrapment of Device

  IT WAS REPORTED THAT TWO STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICES BECAME STUCK IN VESSEL AND ONE WAS OBSERVED TO BE BENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25683770 ↗
• InjuryJul 1, 2026Entrapment of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT TWO STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICES BECAME STUCK IN VESSEL AND ONE WAS OBSERVED TO BE BENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25683629 ↗
• InjuryJun 25, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING PROCEDURE THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS STUCK WHILE IN USE. THERE WAS NO TISSUE/PLAQUE OBSERVED ON THE OAD UPON REMOVAL FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623105 ↗
• MalfunctionJun 11, 2026Break

  IT WAS REPORTED THAT DURING PREPARATION THE DRIVESHAFT PROXIMAL TO THE CROWN OF THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOOSE AND THE OAD WAS NOT USED. THE ISSUE WAS FOUND AFTER REMOVING THE OAD FROM THE PACKAGE. THE OAD DID NOT ENTER THE ANATOMY. THE OAD WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DEVICE ANALYSIS IDENTIFIED FOUND THE DISTAL TIP OF THE SALINE SHEATH TO BE SEPARATED BUT STILL ON THE DRIVESHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473991 ↗
• 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 ↗
• MalfunctionMar 12, 2026Material Separation

  IT WAS REPORTED THAT DURING TREATMENT OF A MODERATELY CALCIFIED UNSPECIFIED ARTERY IN LOWER EXTREMITY WITH A 1.25 MICRO STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IT FELT ABNORMAL. THE OAD WAS REMOVED AND THE TIP OF THE SALINE SHEATH WAS OBSERVED FREE FLOATING ON THE OAD DRIVESHAFT. THE OAD WAS REPLACED WITH SAME TYPE AND SIZE OAD TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO INDICATION AS TO WHY THE DETACHMENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582440 ↗
• InjuryMar 12, 2026Unexpected Shutdown

  IT WAS REPORTED THAT DURING PROCEDURE, STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT CALCIFIED PROXIMAL ANTERIOR TIBIAL ARTERY FROM PEDAL ACCESS. AFTER TWO TO THREE TREATMENTS, THE OAD WAS HEARD BOGGING DOWN. THE OAD WAS REMOVED AND A SMALL PERFORATION WAS OBSERVED. A BALLOON WAS INFLATED TO TAMPONADE THE PERFORATION. PERFORATION WAS RESOLVED AFTER THE BALLOON WAS INFLATED FOR TWO MINUTES. THE PATIENT WAS STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 24582294 ↗
• MalfunctionDec 19, 2025Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS DEFECTIVE. DETAILED ANALYSIS ON THE RETURNED OAD SHOWED THE DEVICE WAS USED ON (B)(6) 2023. DETAILED ANALYSIS SHOWED THAT THE DEVICE WAS POWERED AND NOT SPUN DURING THE PROCEDURE. DETAILED ANALYSIS SHOWED THREE HIGH SPINS AND TWO MEDIUM SPINS AND NO ISSUES WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23852701 ↗
• 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 ↗
• InjuryOct 3, 2025Off-Label Use; Difficult to Remove; Device-Device Incompatibility; Unexpected Shutdown; Off-Label Use; Difficult to Remove; Device-Device Incompatibility; Unexpected Shutdown

  IT WAS REPORTED THAT THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED WITH THE ABBOTT COMMAND GUIDE WIRE. THE 60-70% STENOSED POPLITEAL ARTERY POST INTRAVASCULAR ULTRASOUND (IVUS) WAS TREATED SUCCESSFULLY. THE OAD WAS THEN ADVANCED DISTALLY TO THE CALCIFIED, 70-80% STENOSED POSTERIOR TIBIAL (PT) ARTERY. THE OAD STALLED IN THE DISTAL PT. THE COMMAND WIRE BECAME STUCK ON THE OAD AND HAD TO BE REMOVED TOGETHER CAUSING LOSS OF WIRE ACCESS. A SMALL PERFORATION WAS OBSERVED IN THE DISTAL PT WHERE THE OAD CROWN STALLED. PLANNED PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO RESOLVE THE PERFORATION. THE PATIENT WAS STABLE. WHILE EX VIVO, THE PHYSICIAN WAS ABLE TO REMOVE THE COMMAND WIRE OUT OF THE OAD. THE PHYSICIAN UNDERSTOOD USING THE COMMAND WIRE WITH THE OAD IS OFF LABEL AND THE INSTRUCTIONS FOR USE (IFU) WAS NOT DIFFICULT TO READ/UNDERSTAND. THE PHYSICIAN WAS ALLEGING MALFUNCTION OF THE OAD.

  Patient problems: Perforation of Vessels

  MAUDE report 23211158 ↗
• InjuryOct 3, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF 99% STENOSED MID ANTERIOR TIBIAL ARTERY (AT). THE VESSEL WAS SMALL AND TORTUOUS. THE OAD BECAME STUCK ON THE VIPERWIRE ADVANCE GUIDE WIRE IN THE VESSEL. THE PROCEDURE WAS ABORTED AND THE OAD AND VIPERWIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS ABORTED DUE TO PATIENT ANATOMY AND THE OAD UNABLE TO BE SEPARATED FROM VIPERWIRE. THE PATIENT WAS BROUGHT BACK TWO DAYS LATER FOR PLAIN OLD BALLOON ANGIOPLASTY (POBA) ON THE SAME VESSEL WHICH WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO A HOSPITAL THAT DAY FOR AMPUTATION WHERE BELOW-THE-KNEE AMPUTATION WAS PERFORMED THE SAME DAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THREE DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23211033 ↗
• InjuryOct 1, 2025Material Separation; Material Separation

  IT WAS REPORTED A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DRIVESHAFT FRACTURED DURING TREATMENT OF THE ANTERIOR TIBIAL ARTERY (AT). THE FRACTURED COMPONENT WAS RETRIEVED WITH AN UNSPECIFIED BALLOON. IT WAS INDICATED THE FRACTURE LIKELY OCCURRED DURING AN AGGRESSIVE TRANSITION TO THE AT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190244 ↗
• 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 ↗

Other Cardiovascular Systems, Inc. products

• Diamondback Coronary7 models · 616 reports
• Diamondback Peripheral33 models · 346 reports
• ViperWire2 models · 214 reports
• ViperWire Advance FlexTip4 models · 188 reports
• ViperWire, Advance2 models · 55 reports · 1 recall