Stealth PRD-SC30-150 (REF 7-10059-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10850000491288), received between Apr 5, 2021 and Jul 1, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• 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 ↗
• 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 ↗
• InjuryApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE 1.5 SOLID STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED ANTEGRADE TO TREAT LESION IN LEFT FEMORAL ARTERY. FOLLOWING PROXIMAL-TO-DISTAL TREATMENT, THE OAD WAS REMOVED AND THE LAST 2 CM OF THE DISTAL END OF THE DRIVESHAFT PAST THE CROWN WAS OBSERVED TO BE FRACTURED AND REMAINED IN MID SUPERFICIAL FEMORAL ARTERY (SFA). REMOVAL OF THE FRACTURED COMPONENT WITH A BALLOON AND RETRACTING INTO THE SHEATH WAS ATTEMPTED; HOWEVER, IT WAS UNSUCCESSFUL. THE FRACTURED COMPONENT WAS STENTED TO THE ARTERY WALL IN MID SFA. THE SFA WAS PATENT, WITH GOOD STENT APPOSITION KEEPING THE FRAGMENT FROM MIGRATING AND KEEPING THE SFA OPEN. THERE WAS NO HARM DONE TO PATIENT. THERE ARE NO PLANS TO REMOVE THE FRAGMENT AS IT IS STENTED AND TRAPPED BETWEEN THE STENT AND INTIMAL WALL OF THE ARTERY. TRYING TO RETRIEVE THE FRAGMENT WOULD DO MORE HARM THAN GOOD. THERE WAS NO CLEAR INDICATION AS TO HOW THE FRACTURE OCCURRED, HOWEVER, THE PATIENT WAS MOVING A LOT DURING THE PROCEDURE LIFTING AND LOWERING THEIR LEG, WHICH COULD HAVE CONTRIBUTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21921365 ↗
• MalfunctionJan 27, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ATTEMPTED TO BE USED TO TREAT A LOWER-EXTREMITY LESION THROUGH LEFT COMMON FEMORAL ACCESS BUT COULD NOT BE ADVANCED UP AND OVER. THE PHYSICIAN SWITCHED TO PEDAL, ANTERIOR TIBIAL ACCESS WITH A 5 X 6 SLENDER GUIDING SHEATH. THE OAD WAS ABLE TO BE ADVANCED AND THE PROCEDURE WAS COMPLETED. DURING REMOVAL OF THE OAD WHILE BEING FLUSHED WITH SALINE TO AID WITH THE REMOVAL, IT WAS NOTICED THAT THERE WAS A SALINE LEAK NEAR THE DISTAL END OF THE OAD IN-BODY SECTION / SALINE SHEATH, ABOUT 6 INCHES FROM THE CROWN. THE FLOW OF SALINE TO THE TIP OF THE OAD WAS CONSIDERED SUFFICIENT ENOUGH TO AVOID INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ABBOTT SALES REPRESENTATIVE ON 03 JANUARY 2025 INDICATING THE OAD SALINE SHEATH APPEARED TO BE PUNCTURED WHEN REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241940 ↗
• MalfunctionJan 6, 2025Difficult to Remove; Material Separation; Unexpected Shutdown; Difficult to Remove; Material Separation; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT MODERATE TO SEVERELY CALCIFIED LESION (5 MM IN DIAMETER AND 120 MM IN LENGTH) IN THE PROXIMAL AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS INITIALLY SPUN IN IN THE PROXIMAL LESION SUCCESSFULLY. IT WAS REPOSITIONED TO THE DISTAL LESION AND WAS SPUN ON LOW AND MEDIUM SPEED. THE OAD SEEMED TO TORQUE DOWN AND STOPPED WHEN IT WAS SPUN ON HIGH SPEED AT THE AREA OF PATELLA. THE OAD COULD NOT TURN ON AGAIN. THERE WAS DIFFICULTY DURING REMOVAL OF THE OAD OVER THE GUIDEWIRE. THE OAD AND THE GUIDEWIRE WERE REMOVED TOGETHER. WHEN THE OAD WAS REMOVED OUT OF THE SHEATH, IT WAS NOTED THAT THE DRIVESHAFT OF THE CATHETER WAS FRACTURED AND IT WAS BELIEVED TO BE THE CAUSE OF THE ISSUES DURING REMOVAL. IT WAS FURTHER NOTED THAT THE AREA OF THE FRACTURE WAS WHERE THE SHAFT OF OAD WENT UP AND OVER THE ILIAC BIFURCATION AND WAS, THEREFORE, INSIDE THE SHEATH. THE PHYSICIAN REWIRED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21082861 ↗
• MalfunctionOct 14, 2024Entrapment of Device; Difficult to Remove; Contamination /Decontamination Problem; Entrapment of Device; Difficult to Remove; Contamination /Decontamination Problem

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ATTEMPTED TO BE USED FOR TREATMENT OF 70% STENOSED, MODERATELY CALCIFIED, 6MM-DIAMETER LESION IN RIGHT COMMON FEMORAL ARTERY (CFA). PEDAL ACCESS VIA RIGHT POSTERIOR TIBIAL ARTERY (PT) WAS GAINED AND INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO IMAGE THE RIGHT LOWER EXTREMITY. A 6FR GUIDING SHEATH WAS IN USE. THE RIGHT PT HAD DIFFUSE MODERATE CALCIUM BUT THE PHYSICIAN FELT LIKE THEY COULD ADVANCE A 1.5 SOLID OAD THROUGH THE PT AND UP TO THE CFA AND SUPERFICIAL FEMORAL ARTERY (SFA) TO TREAT. THE RIGHT SFA WAS 80% STENOSED, MODERATELY CALCIFIED AND 5MM IN DIAMETER. UPON ADVANCING THE OAD, RESISTANCE WAS MET AND THE OAD COULD NOT BE ADVANCED THROUGH THE PT. WHEN TRYING TO TAKE AN IMAGE AND INJECTING THROUGH THE PEDAL SHEATH, EXTRAVASATION WAS OBSERVED. OAD REMOVAL WAS ATTEMPTED BUT MET RESISTANCE. AS THE OAD COULD NOT BE ACTIVATED, THE PHYSICIAN KNEW THAT THE RIGHT PT HAD SPASMED OVER THE OAD. THE OAD WAS ABLE TO BE REMOVED ALONG WITH THE VIPERWIRE AND SHEATH BY STEADILY PULLING THE OAD WITH A LITTLE TENSION. EX VIVO, THE VIPERWIRE WAS FOUND STUCK WITHIN THE OAD. THERE WAS NO TISSUE OR PLAQUE OBSERVED ON THE OAD. AFTER MAINTA

  Patient problems: Perforation of Vessels; Vasoconstriction

  MAUDE report 20445625 ↗
• InjurySep 9, 2022Entrapment of Device; Entrapment of Device

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE VESSEL. AN EXTENDED PERIOD OF TIME WAS SPENT NAVIGATING DEVICE REMOVAL. AFTER MANEUVERING THE SHEATH, THE OAD WAS REMOVED WITH NO ISSUE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15388448 ↗
• MalfunctionAug 18, 2022Material Separation; Material Separation

  DURING TREATMENT, THE STEALTH GEN2 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ON LOW SPEED AND PASSED TWICE THROUGH THE POPLITEAL ARTERY. DURING THE THIRD PASS, ON MEDIUM SPEED, THE DEVICE BECAME JAMMED ON THE WIRE. TROUBLESHOOTING WAS ATTEMPTED TO RESOLVE THE EVENT, HOWEVER, THE ISSUE PERSISTED. A SPIN TEST WAS NOT TESTED PRIOR TO IN VIVO USE. THE SYSTEM WAS REMOVED; NO DAMAGE WAS OBSERVED ON THE GUIDE WIRE OR DRIVESHAFT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE PHYSICIAN SUSPECTED THAT THERE MAY HAVE BEEN SOMETHING CAUGHT IN THE DRIVESHAFT IN THE DEVICE INNER WORKINGS THAT MAY HAVE RESULTED IN A BUILDUP OF TENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254750 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS INTENTIONALLY OPERATED SUBINTIMAL AND SEIZED DURING TREATMENT TO THE POSTERIOR TIBIAL ARTERY. THE OAD WAS REMOVED, AND TORQUE BUILD UP WAS OBSERVED IN THE SALINE SHEATH. IMAGING REVEALED A TISSUE EMBOLUS AND ASPIRATION WAS PERFORMED TO REMOVE THE INTIMA PIECE. TREATMENT WAS CONTINUED WITH A SECOND OAD AND WHEN THE GUIDE WIRE WAS REMOVED A SECOND PIECE OF INTIMA WAS STUCK ON THE GUIDE WIRE TIP AS A RESULT OF THE EMBOLI TRAVELING DOWNSTREAM AND BECOMING STUCK ON THE GUIDE WIRE.

  Patient problems: Embolism/Embolus

  MAUDE report 12926997 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH CRITICAL LIMB ISCHEMIA PRESENTED WITH HEAVILY CALCIFIED LESIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL, TIBIOPERONEAL TRUNK (TPT) AND PROXIMAL PERONEAL. TREATMENT WAS PERFORMED WITH A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) ON ALL SPEEDS IN THE SFA, LOW AND MEDIUM SPEEDS IN THE TPT AND PROXIMAL PERONEAL WITH GOOD TECHNIQUE. BALLOON ANGIOPLASTY WAS PERFORMED AT ALL TREATMENT LOCATIONS. ANGIOGRAPHY WAS PERFORMED AND REVEALED SLOW FLOW IN THE SFA AND POPLITEAL AND NO FLOW IN THE UNTREATED MID PERONEAL. THE PERONEAL WAS TREATED WITH BALLOON ANGIOPLASTY, BUT FLOW WAS NOT RESTORED. ANGIOGRAPHY WAS PERFORMED IN THE DISTAL PERONEAL AND IT WAS FOUND TO BE PATENT. BALLOON ANGIOPLASTY WAS PERFORMED AGAIN AND ANGIOGRAPHY RESULTS WERE CONSISTENT WITH EMBOLIZATION OF THE MID PERONEAL. A THROMBECTOMY DEVICE WAS ADVANCED AND THROMBOLYSIS WAS PERFORMED ALONG WITH THROMBECTOMY AND ADMINISTRATION OF TISSUE PLASMINOGEN ACTIVATOR. ANGIOGRAPHY REVEALED IMPROVED PERONEAL FLOW, HOWEVER SLOW FLOW WAS STILL NOTED. BALLOON ANGIOPLASTY WAS AGAIN PERFORMED AND SLOW FLOW REMAINED, HOWEVER FLOW IN THE PERONEAL WAS CONTINUOUS TO THE FOOT AND A DOPPLER SIGNAL TO THE DOR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Embolism/Embolus

  MAUDE report 12790572 ↗
• InjuryOct 6, 2021Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  MATERIAL RESEMBLING A STENT WAS OBSERVED ON THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DURING DEVICE ANALYSIS FOR A NON-REPORTABLE COMPLAINT (DEVICE STALL AND RESISTANCE DURING REMOVAL). IT APPEARED DURING ANALYSIS THAT THE OAD HAD INADVERTENTLY CONTACTED A PRE-EXISTING STENT. APPARENTLY, THE STENT WAS INADVERTENTLY EXTRACTED WHEN THE OAD WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583163 ↗
• MalfunctionApr 21, 2021Infusion or Flow Problem; Infusion or Flow Problem

  EXCESSIVE FLUID EXITED THE STRAIN RELIEF OF THE STEALTH GEN 2 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) FOLLOWING THE FIRST TREATMENT. TWO MORE TREATMENTS WERE ADMINISTERED, AND BLOOD BACKED UP INTO THE SALINE SHEATH. THE OAD WAS REMOVED FROM THE PATIENT, AND A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699762 ↗
• MalfunctionApr 8, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS REMOVED FOLLOWING EIGHT TREATMENTS. BLOOD LEAKED FROM A SMALL CRACK IN THE SALINE SHEATH OF THE OAD. FOLLOWING THE BLOOD LEAKAGE, VIPERSLIDE THEN LEAKED FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637630 ↗
• InjuryApr 5, 2021Entrapment of Device; Entrapment of Device

  A STEALTH PERIPHERAL GEN2 ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A CALCIFIED, 90% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. AFTER TREATMENT, THE OAD BECAME STUCK ON THE GUIDE WIRE. THE OAD, GUIDE WIRE, AND NON-CSI FILTER WERE ALL REMOVED TOGETHER, AND A FILTER RETRIEVAL CATHETER WAS UNABLE TO BE USED. THE CONTENT OF THE FILTER WAS POSSIBLY SPILLED DURING THE RETRIEVAL. NO DAMAGE WAS OBSERVED ON THE OAD OR GUIDE WIRE. BIOLOGICAL EMBOLI WAS OBSERVED IN THE VESSEL. A SECOND NON-CSI FILTER WAS DEPLOYED DISTAL TO THE EMBOLIZATION, AND THE EMBOLI WAS CAPTURED. THE PATIENT WAS DISCHARGED HOME FOLLOWING THE PROCEDURE.

  Patient problems: Embolism/Embolus

  MAUDE report 11615980 ↗