Stealth PRD-SC30-125 (REF 70056-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10852528005039), received between Aug 13, 2015 and Nov 22, 2019 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Material Separation; Material Separation

  A STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR USE IN THE LEFT PERONEAL, PROXIMAL POPLITEAL, AND DISTAL SUPERIOR FEMORAL ARTERIES. TREATMENT WAS DELIVERED TO A LESION IN THE PROXIMAL PERONEAL ARTERY WITHOUT ISSUE. DURING PULLBACK TO THE POPLITEAL AREA, THE DEVICE WAS SPUN, AND THE WIRE SEEMED TO ARC. TENSION WAS OBSERVED, AND THE CROWN JUMPED AND STOPPED SPINNING. THE OAD CROWN WAS NOW DISTAL TO THE LESION, AND IT WAS RE-POSITIONED WITHOUT SPINNING. WHEN THE DEVICE WAS TURNED ON FOR DISTAL-TO-PROXIMAL TREATMENT, IT SPUN MOMENTARILY BUT STOPPED SPINNING AGAIN. THE OAD WAS THEN RETRACTED IN ORDER TO REMOVE IT FROM THE PATIENT. TENSION WAS AGAIN OBSERVED. WHILE STILL NOT SPINNING, THE OAD JUMPED BACK INTO THE SHEATH. WHEN THE OAD WAS REMOVED FROM THE PATIENT, THE DRIVESHAFT WAS UNRAVELED, AND THE OAD WAS STILL ON THE GUIDE WIRE. THE OAD WAS REMOVED IN ONE SINGLE PIECE AND NOT IN SEPARATE PIECES. ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED WITHOUT ISSUE. AFTER INSPECTING THE DAMAGE, THE PHYSICIAN CATEGORIZED THE DAMAGE AS A FRACTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9364302 ↗
• MalfunctionSep 12, 2019Entrapment of Device; Fluid/Blood Leak; Melted; Material Separation; Noise, Audible; Entrapment of Device; Fluid/Blood Leak; Melted; Material Separation; Noise, Audible

  DURING A PROCEDURE, THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) MADE AN UNUSUAL NOISE AND BECAME STUCK ON THE GUIDE WIRE. THE PHYSICIAN INITIALLY CUT THE SHEATH AND A BIT OF THE DRIVESHAFT INTENDING TO ADVANCE THE SHEATH OVER THE CROWN TO ATTEMPT TO LOOSEN THE OAD FROM THE GUIDE WIRE. HOWEVER, THE PHYSICIAN DECIDED TO REMOVE THE OAD AND GUIDE WIRE FROM THE PATIENT TOGETHER. A SLOW LEAK WAS OBSERVED ON THE DRIVESHAFT SHEATH NEAR THE DISTAL END OF THE DEVICE. THE VESSEL WAS REWIRED, AND A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. THE OAD WAS RECEIVED BY ANALYSIS AND WAS FOUND TO HAVE FRACTURED DRIVESHAFT FILARS LOCATED WITHIN THE SALINE SHEATH. THE FACILITY WAS UNAWARE OF THE FRACTURES WITHIN THE SALINE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9010535 ↗
• MalfunctionJul 11, 2019Melted; Infusion or Flow Problem; Melted; Infusion or Flow Problem

  DURING A PROCEDURE, A MILD TO MODERATELY CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY WAS TREATED WITH A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) VIA A FEMORAL APPROACH. WHEN THE OAD WAS TREATING THE LESION, FLUID WAS NOTED TO BE SPRAYING OUT OF A HOLE IN APPROXIMATELY THE MID-POINT OF THE DRIVESHAFT. THE SECTION OF THE DRIVESHAFT SPRAYING LIQUID WAS STILL LOCATED OUTSIDE OF THE BODY. A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE ALONG WITH BALLOON ANGIOPLASTY, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8780979 ↗
• MalfunctionOct 17, 2018Infusion or Flow Problem; Infusion or Flow Problem

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DEVICE MALFUNCTION OCCURRED. DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED THAT THE SALINE SOLUTION WOULD NOT ADVANCE THROUGH THE TUBING OF THE PERIPHERAL DEVICE. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973603 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), SLOW FLOW, THROMBUS AND VESSEL SPASMS OCCURRED. FOLLOWING ATHERECTOMY, BALLOON ANGIOPLASTY WAS PERFORMED. FOLLOWING BALLOON TREATMENT, SLOW FLOW, THROMBUS AND VESSEL SPASMS OCCURRED. ASPIRATION WAS PERFORMED TO RESOLVE THE THROMBUS AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 7488060 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A SLOW FLOW EVENT OCCURRED. THE TARGET LESION WAS TREATED USING MULTIPLE PASSES WITH THE OAD AT LOW SPEED. WHEN IMAGING WAS PERFORMED, THE FLOW WAS SLOWER THAN ANTICIPATED. THE LESION WAS TREATED AGAIN USING MULTIPLE PASSES WITH THE OAD AT MEDIUM SPEED, HOWEVER THE FLOW WAS STILL OBSERVED TO BE SLOW. BALLOON ANGIOPLASTY WAS PERFORMED AND VASODILATORS WERE ADMINISTERED, HOWEVER THE SLOW FLOW WAS NOT RESOLVED. BALLOON ANGIOPLASTY WAS PERFORMED AGAIN IN MULTIPLE LOCATIONS WITHIN THE VESSEL, HOWEVER THE PROCEDURE WAS COMPLETED WITHOUT RESOLUTION OF THE SLOW FLOW. THE PATIENT REMAINED HOSPITALIZED, AND AN ULCER PRESENT ON THE TOE OF THE PATIENT PRIOR TO THE PROCEDURE WAS NOTED TO WORSEN. AMPUTATION OF THE TOE WAS PERFORMED ON (B)(6) AND THE PATIENT WAS DISCHARGED ON (B)(6). PER THE PHYSICIAN, THE AMPUTATION WAS UNRELATED TO THE PERFORMANCE OF ANY CSI DEVICE.

  Patient problems: Deformity/ Disfigurement; No Code Available

  MAUDE report 7341288 ↗
• InjuryOct 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON FEMORAL ARTERY (CFA). THE PHYSICIAN USED A 5FR INTRODUCER SHEATH AND A CSI VIPERWIRE GUIDE WIRE TO ACCESS THE LESION. A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO THE GUIDE WIRE AND ADVANCED JUST PROXIMAL TO THE LESION. THE PHYSICIAN PERFORMED MULTIPLE RUNS AT LOW, MEDIUM AND AT HIGH SPEED TO TREAT THE LESION. DURING THE FINAL RUN, IT WAS NOTED THAT THE TIP OF THE OAD FRACTURED OFF. THE OAD WAS REMOVED FROM THE PATIENT AND A SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVE THE TIP OF THE OAD FROM THE PATIENT. THE PHYSICIAN THEN PERFORMED EIGHT ADDITIONAL RUNS USING A SECOND OAD TO COMPLETE TREATMENT OF THE LESION. THE PHYSICIAN FOLLOWED-UP ATHERECTOMY BY PERFORMING THREE BALLOON ANGIOPLASTY INFLATIONS. AT THIS POINT, ANGIOGRAPHY REVEALED A DISSECTION WHICH WAS SUCCESSFULLY RESOLVED BY DEPLOYING TWO STENTS. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 6010530 ↗
• InjuryMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION AND A TYPE A DISSECTION OCCURRED. THE EVENTS WERE IDENTIFIED BY A THIRD PARTY VENDOR, (B)(4). (B)(4) REVIEWED ALL PROCEDURAL ANGIOGRAMS AS PART OF A (B)(4) CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE PERONEAL ARTERY. THE PHYSICIAN USED A 5FR INTRODUCER SHEATH TO ACCESS THE LESION. A (B)(4) VIPERWIRE WAS ADVANCED ACROSS THE LESION AND A (B)(4) ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO IT. THE PHYSICIAN SUCCESSFULLY TREATED THE LESION USING THE OAD AND FOLLOWED-UP ATHERECTOMY WITH BALLOON ANGIOPLASTY. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT. FOLLOW-UP REVIEW BY (B)(4) IDENTIFIED A PERFORATION AND A TYPE A DISSECTION; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE. THE (B)(4) ANGIOGRAM EVALUATION WAS REVIEWED BY (B)(4) FOR POTENTIAL ADVERSE EVENTS ON (B)(6) 2016.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 5684792 ↗
• InjuryMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION AND A TYPE B DISSECTION OCCURRED. THE EVENTS WERE IDENTIFIED BY A THIRD PARTY VENDOR, CORE LAB. CORE LAB REVIEWED ALL PROCEDURAL ANGIOGRAMS AS PART OF A CSI CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL (PT) ARTERY. THE PHYSICIAN USED A 6FR/60CM INTRODUCER SHEATH TO ACCESS THE LESION. A CSI VIPERWIRE WAS ADVANCED ACROSS THE LESION AND A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO IT. THE PHYSICIAN SUCCESSFULLY TREATED THE LESION USING THE OAD AND FOLLOWED-UP ATHERECTOMY WITH BALLOON ANGIOPLASTY. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT. FOLLOW-UP REVIEW BY CORE LAB IDENTIFIED A PERFORATION AND A TYPE B DISSECTION; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE. THE CORE LAB ANGIOGRAM EVALUATION WAS REVIEWED BY CSI FOR POTENTIAL ADVERSE EVENTS ON (B)(6) 2016.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 5684788 ↗
• InjuryOct 14, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE PATIENT EXPERIENCED A THROMBUS EVENT AFTER TREATMENT WITH A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THERE WERE LESIONS LOCATED IN THE RIGHT POPLITEAL (POP), ANTERIOR TIBIAL (AT), TIBIOPERONEAL TRUNK (TPT) AND PERONEAL (PR) ARTERIES. THE PHYSICIAN USED A CONTRALATERAL APPROACH TO ACCESS THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 6-FRENCH INTRODUCER SHEATH, THEN CROSSED THE POPLITEAL OCCLUSION WITH A CXI 0.035 CATHETER AND AN AMPLATZ WIRE. THE CROSSING WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDEWIRE, WHICH WAS INTRODUCED INTO THE AT. THE PHYSICIAN TREATED THE POP WITH LASER ATHERECTOMY, FOLLOWED BY BALLOON ANGIOPLASTY AND THE PLACEMENT OF TWO STENTS TO REPAIR A DISSECTION. THE STENTS WERE THEN FURTHER DILATED WITH A 6MM BALLOON. THE PHYSICIAN THEN EXCHANGED THE LASER ATHERECTOMY DEVICE FOR A CSI OAD AND TREATED THE RIGHT AT AT LOW, MEDIUM AND HIGH SPEEDS FOLLOWED BY BALLOON ANGIOPLASTY. THEN THE VIPERWIRE WAS REDIRECTED VIA THE TPT INTO THE PR WHERE ADDITIONAL ATHERECTOMY WAS PERFORMED WITH THE CSI OAD. AFTER THE TREATMENT IN THE PR, A DISTAL EMBOLIZATION WAS NOTED. THIS WAS TREATED WITH 4MG OF TISSUE PLASMIN

  Patient problems: Thrombus

  MAUDE report 5149815 ↗
• InjurySep 29, 2015Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A CSI ORBITAL ATHERECTOMY DEVICE (OAD) GOT STUCK IN THE PATIENT AND HAD TO BE SURGICALLY REMOVED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN PERFORMED MULTIPLE RUNS AT LOW SPEED USING THE CSI OAD. DURING THE FINAL RUN, THE OAD MADE A HIGH PITCHED NOISE AND THE CSI SALINE INFUSION PUMP (SIP) SWITCHED TO STAND-BY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE TO PERFORM ANGIOGRAPHY, BUT DISCOVERED THAT IT WAS STUCK. AFTER MULTIPLE UNSUCCESSFUL REMOVAL ATTEMPTS, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF THE OAD. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. THE OAD WAS RETAINED BY THE FACILITY, BUT THE SALINE INFUSION PUMP WAS RETURNED FOR ANALYSIS. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE, BUT WERE DENIED BY THE FACILITY DUE TO INTERNAL POLICIES.

  Patient problems: No Code Available

  MAUDE report 5112129 ↗
• InjurySep 10, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, MULTIPLE DISSECTIONS OCCURRED WHILE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS 80% STENOTIC, 150MM IN LENGTH AND WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN USED A 6FR INTRODUCER SHEATH FROM A RETROGRADE APPROACH TO ACCESS THE LESION. MULTIPLE RUNS WERE PERFORMED USING THE OAD AT LOW, MEDIUM AND AT HIGH SPEED. POST-ATHERECTOMY ANGIOGRAPHY REVEALED MULTIPLE DISSECTION PLANES. THE PHYSICIAN RESOLVED THE DISSECTIONS BY DEPLOYING TWO ZILVER PTX STENTS. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 5067264 ↗
• InjuryAug 13, 2015Device Stops Intermittently

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A CSI ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK ON THE GUIDEWIRE. ADDITIONALLY, A PERFORATION HAD OCCURRED DURING USE WITH THE OAD. THE TARGET LESION WAS 2CM IN LENGTH AND WAS 90% STENOTIC. IT WAS LOCATED IN THE DISTAL ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN ACCESSED THE LESION USING A 6FR INTRODUCER SHEATH AND A 0.014" REGALIA GUIDEWIRE. THE PHYSICIAN EXCHANGED THE REGALIA WIRE FOR A CSI VIPERWIRE GUIDEWIRE AND LOADED THE OAD ONTO IT. DURING THE FIRST RUN AT LOW SPEED, THE DEVICE LOCKED DOWN ON THE GUIDEWIRE. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO REMOVE THE OAD, BUT WAS UNSUCCESSFUL. THE OAD AND GUIDEWIRE WERE THEN REMOVED AS A UNIT, BUT FOLLOW-UP ANGIOGRAPHY REVEALED A PERFORATION. THE PHYSICIAN WAS UNABLE TO ADVANCE A GUIDEWIRE PAST THE PERFORATION TO RESOLVE IT, SO HE PROLAPSED AND COILED THE TIP OF THE WIRE. A BALLOON WAS THEN ADVANCED OVER THE GUIDEWIRE AND INFLATED TO STOP BLOOD FLOW TO THE PERFORATION. HEPARIN ADMINISTRATION WAS STOPPED AT THIS POINT TO PROMOTE CLOTTING, AND THE PERFORATION EVENTUALLY RESOLVED. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. REQUESTS FOR ADDITIONAL

  Patient problems: Great Vessel Perforation

  MAUDE report 5001882 ↗
• InjuryAug 13, 2015Break

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF A CSI ORBITAL ATHERECTOMY DEVICE (OAD) BROKE OFF AND WAS LEFT IN THE PATIENT. THE TARGET LESION WAS SEVERELY CALCIFIED, 90% STENOTIC AND WAS 3-4CM IN LENGTH. IT WAS LOCATED IN THE POSTERIOR TIBIAL (PT) ARTERY, BUT ORIGINATED IN THE TIBIO-PERONEAL TRUNK (TPT). THE PHYSICIAN USED A 6FR/70CM INTRODUCER SHEATH AND A COMMAND ES GUIDEWIRE TO ACCESS THE LESION. THE COMMAND ES GUIDEWIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDEWIRE AND THE OAD WAS LOADED ONTO IT. THE PHYSICIAN PERFORMED THREE RUNS AT LOW SPEED AND ONE RUN AT MEDIUM SPEED. DURING THE FINAL RUN, THE DEVICE SEEMED TO JUMP THROUGH THE LESION. WHEN ATTEMPTING TO REMOVE THE OAD, THE PHYSICIAN DISCOVERED THAT THE DISTAL TIP OF THE DEVICE WAS NOT RETRACTING WITH THE PROXIMAL DRIVESHAFT SECTION. THE PROXIMAL OAD DRIVESHAFT SECTION WAS REMOVED AND THE PHYSICIAN THEN USED A 2.5X23MM DRUG-ELUTING STENT TO PIN THE DISTAL DRIVESHAFT TIP AGAINST THE VESSEL WALL. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. THREE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NONE HAS YET BEEN RECEIVED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 5001847 ↗