Stealth PRD-SC30-150 (REF 70056-04)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10852528005046), received between Sep 17, 2015 and Aug 13, 2020 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (6 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.

• InjuryAug 13, 2020Entrapment of Device; Use of Device Problem; Entrapment of Device; Use of Device Problem

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE RIGHT LEG VIA PEDAL ACCESS. IT WAS UNKNOWN THAT A PREVIOUSLY PLACED STENT WAS PRESENT IN THE PROXIMAL POSTERIOR TIBIAL ARTERY, AND THE OAD CONTACTED THE STENT WHILE SPINNING. THE OAD WAS REMOVED FROM THE STENT INTACT AND THE VIPERWIRE GUIDE WIRE WAS LEFT IN PLACE, HOWEVER NO ADDITIONAL BALLOONS OR CATHETERS WERE ABLE TO CROSS THE DAMAGED STENT TO PERFORM ADDITIONAL TREATMENT. BALLOON INFLATION WAS PERFORMED WITHIN THE STENT SUCCESSFULLY. THE PATIENT WAS STABLE FOR THE DURATION OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10402868 ↗
• InjuryFeb 28, 2020Entrapment of Device; Entrapment of Device

  AFTER TWO TREATMENT PASSES, THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE GUIDE WIRE BECAME STUCK IN THE ANTERIOR TIBIAL ARTERY. THE OAD AND GUIDE WIRE WERE CUT TO FACILITATE REMOVAL ATTEMPTS. A NON-CSI 8FR SHEATH WAS INSERTED INTO THE PATIENT TO REMOVE THE CROWN AND GUIDE WIRE, BUT WAS UNSUCCESSFUL. THE SHEATH WAS EXCHANGED FOR A NON-CSI 10F SHEATH, AND THE CROWN AND GUIDE WIRE WERE REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DISCHARGED THE SAME DAY. ANALYSIS OF THE DEVICE CONFIRMED THE PRESENCE OF ADHERED STENT MATERIAL ON THE CROWN OF THE OAD. IT WAS UNKNOWN THAT A PREVIOUSLY PLACED STENT WAS PRESENT IN THE PATIENT, AND THAT THE DEVICE HAD INADVERTENTLY OPERATED WITHIN THE STENT.

  Patient problems: No Known Impact Or Consequence To Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 9771979 ↗
• InjuryFeb 12, 2020Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  DURING A PROCEDURE, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO THE TARGET, 70% STENOSED LESION LOCATED IN AN AREA OF THE PERONEAL ARTERY THAT WAS APPROXIMATELY 3 MILLIMETERS IN DIAMETER. THE TARGET LESION VARIED BETWEEN MILD AND SEVERE CALCIFICATION AND WAS ACCESSED VIA A FEMORAL APPROACH. THE OAD STOPPED SPINNING AS SOON AS IT WAS TURNED ON, AND THERE WERE NO LED LIGHTS LIT ON THE OAD HANDLE. TROUBLESHOOTING WAS ATTEMPTED, BUT THE ISSUE RECURRED. IN THE PHYSICIAN'S OPINION, THE OAD AND GUIDE WIRE WERE NOT SUBINTIMAL AND THE GUIDE WIRE WAS NOT KINKED. THE OAD WAS REMOVED FROM THE PATIENT, AND BRIEFLY BECAME STUCK DURING REMOVAL, HOWEVER, IT THEN WAS REMOVED SMOOTHLY. A POSSIBLE PIECE OF INTIMA WAS OBSERVED ON THE CROWN OF THE OAD. IMAGING WAS PERFORMED, AND A TYPE C DISSECTION WAS PRESENT IN THE PERONEAL ARTERY. BALLOON ANGIOPLASTY, WHICH HAD BEEN ORIGINALLY SCHEDULED, WAS THEN PERFORMED IN THE PERONEAL ARTERY. A SECOND OAD WAS USED TO TREAT ANOTHER LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) SUCCESSFULLY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 9701356 ↗
• MalfunctionJan 6, 2020Entrapment of Device; Fluid/Blood Leak; Material Separation; Entrapment of Device; Fluid/Blood Leak; Material Separation

  DURING A PROCEDURE, THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) SOUNDED LIKE IT WAS LOSING POWER, AND IT SHUT OFF. IT WAS NOTED THERE WERE NO LED LIGHTS LIT ON THE OAD. AN ATTEMPT WAS MADE TO REMOVE THE OAD, HOWEVER, IT WAS STUCK ON THE GUIDE WIRE. THE OAD AND GUIDE WIRE WERE REMOVED TOGETHER AND WIRE ACCESS WAS LOST. AS THE OAD WAS BEING REMOVED, LEAKING WAS NOTED FROM THE MIDDLE OF THE DRIVESHAFT SHEATH AT A LOCATION THAT WAS IN THE PATIENT, AND THE DRIVESHAFT APPEARED TO BE FRACTURED AT THE LOCATION WHERE THE SHEATH WAS LEAKING. IT WAS CONFIRMED NO DRIVESHAFT FRAGMENTS WERE LEFT IN THE PATIENT. WIRE ACCESS WAS REGAINED, AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY WITH NO SIGNIFICANT DELAY. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9555087 ↗
• MalfunctionJul 23, 2019Entrapment of Device; Entrapment of Device

  DIFFICULTY WAS ENCOUNTERED DURING ADVANCEMENT OF THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) THROUGH THE INSERTION SHEATH. THE OAD WAS EVENTUALLY ABLE TO BE ADVANCED TO TREAT THE POPLITEAL ARTERY, BUT THE OAD BECAME STUCK DURING ADVANCEMENT TO THE SUPERIOR FEMORAL ARTERY (SFA). THE OAD WAS MANUALLY REMOVED BY PULLING. TREATMENT OF THE SFA WAS ABORTED, AND THE PATIENT WAS STAGED FOR A FUTURE BYPASS PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8816538 ↗
• InjuryMay 30, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A PERFORATION OCCURRED IN THE POSTERIOR TIBIAL ARTERY FOLLOWING USE OF THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) TO TREAT A HEAVILY CALCIFIED LESION. THE OAD BECAME STUCK ON THE GUIDE WIRE. A COVERED STENT WAS USED TO COMPLETE THE PROCEDURE WITH NO ADDITIONAL ISSUE. THE OPINION OF THE PHYSICIAN WAS THAT THE OAD CROWN MAY HAVE BEEN TOO LARGE FOR THE VESSEL, WHICH WAS ABOUT 2.0MM IN DIAMETER.

  Patient problems: Perforation of Vessels

  MAUDE report 8654692 ↗
• MalfunctionSep 3, 2018Infusion or Flow Problem; Infusion or Flow Problem

  RESISTANCE WAS ENCOUNTERED, AND THE GUIDE WIRE COULD NOT BE ADVANCED THROUGH THE PERIPHERAL STEALTH ORBITAL ATHERECTOMY DEVICE (OAD). THE BRAKE WAS LIFTED, BUT THE ISSUE PERSISTED. A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE WITH A MINIMAL DELAY OF ONE TO TWO MINUTES. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE. INFORMATION WAS RECEIVED ON (B)(6) 2018 THAT, DURING THE REPORTED EVENT, THE VIPERSLIDE FLUID DID NOT EXIT THE TIP OF THE OAD EITHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7840992 ↗
• MalfunctionMar 2, 2018Device Remains Activated; Device Remains Activated

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DEVICE MALFUNCTION OCCURRED. FOLLOWING TREATMENT OF THE LESION WITH THE OAD, THE DEVICE WOULD NOT POWER OFF AND CONTINUED TO SPIN INSIDE THE VESSEL. THE POWER CORD WAS REMOVED TO POWER OFF THE DEVICE, AND THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7310905 ↗
• InjuryFeb 26, 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 HEMATOMA OCCURRED. THE TARGET LESION WAS 90% STENOSED AND LOCATED IN THE POPLITEAL ARTERY. WHEN THE INITIAL GUIDE WIRE WAS EXCHANGED FOR THE CSI VIPERWIRE, WIRE ACCESS WAS LOST DUE TO MOVEMENT OF THE SHEATH. THE PATIENT THEN PRESENTED WITH A HEMATOMA AT THE ACCESS SITE AND THE SHEATH WAS UNABLE TO BE ADVANCED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Hematoma

  MAUDE report 7295894 ↗
• InjuryJan 11, 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), IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED. THE TARGET LESIONS WERE HEAVILY CALCIFIED AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE LESIONS WERE TREATED USING THE OAD AT LOW AND MEDIUM SPEEDS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND THE PATIENT STATUS BEGAN TO DECLINE. A RAPID RESPONSE TEAM WAS IMPLEMENTED AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING THE PROCEDURE AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Dyspnea

  MAUDE report 7181943 ↗
• InjuryNov 29, 2017Material Separation; Material Separation

  DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED AND REMAINED IN THE PATIENT. AFTER TREATMENT OF THREE TARGET LESIONS, THE DEVICE WAS DIFFICULT TO REMOVE OVER THE GUIDEWIRE. WHEN THE DEVICE AND GUIDEWIRE WERE REMOVED, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE HAD BECOME DETACHED AND REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7068644 ↗
• InjuryMar 24, 2017Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION OCCURRED. THE PATIENT HAD CRITICAL LIMB ISCHEMIA (CLI) AND ATHERECTOMY WAS BEING ATTEMPTED AS A FINAL EFFORT AS THE PATIENT WAS NOT A SURGICAL CANDIDATE. THERE WERE TARGET LESIONS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE PHYSICIAN TREATED THE LESIONS USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), BUT DURING TREATMENT THE OAD SEEMED TO GET STUCK IN THE VESSEL. THE PHYSICIAN WAS ABLE TO FORCEFULLY PULL THE OAD FROM THE PATIENT, BUT ANGIOGRAPHY REVEALED A PERFORATION. THE PERFORATION WAS RESOLVED AND THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. THREE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE, BUT NONE HAS YET BEEN RECEIVED.

  Patient problems: Perforation of Vessels

  MAUDE report 6432510 ↗
• InjuryOct 26, 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, AN ABRUPT VESSEL CLOSURE OCCURRED. THE EVENT WAS 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 130MM IN LENGTH AND WAS LOCATED IN THE ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN TREATED THE LESION USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE PHYSICIAN REMOVED THE OAD AND FOLLOWED-UP ATHERECTOMY WITH BALLOON ANGIOPLASTY. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT. IT WAS NOTED THAT THE AT ARTERY WAS PATENT AT THE END OF THE PROCEDURE, BUT THE DISTAL SEGMENT REMAINED OCCLUDED. FOLLOW-UP REVIEW BY CORE LAB IDENTIFIED AN ABRUPT VESSEL CLOSURE; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6058664 ↗
• InjuryFeb 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF A CSI ORBITAL ATHERECTOMY DEVICE (OAD) BROKE OFF AND REQUIRED SURGICAL REMOVAL. THE TARGET LESION WAS 50% STENOTIC AND WAS LOCATED IN THE ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN USED A 6FRX45CM INTRODUCER SHEATH AND A STIFF GLIDE GUIDE WIRE TO ACCESS THE LESION. THE STIFF GLIDE WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE AND THE OAD WAS LOADED ONTO IT. THE PHYSICIAN COMPLETED THREE RUNS AT LOW SPEED FOR 25-30 SECONDS TOTAL. DURING THE FINAL RUN, THE OAD SEEMED TO BOG DOWN AND STOPPED SPINNING. THE PHYSICIAN ATTEMPTED TO PULL BACK THE OAD AND REMOVE IT, BUT IT WAS STUCK IN THE PATIENT. THE DRIVESHAFT WAS CUT AT THE POINT WHERE IT EXITED THE INTRODUCER SHEATH OUTSIDE THE PATIENT AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REMOVAL. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. THREE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NONE HAS YET BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 5450716 ↗
• InjuryOct 27, 2015Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF A CSI VIPERWIRE GUIDE WIRE BROKE OFF AND WAS LEFT IN THE PATIENT. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A CSI ORBITAL ATHERECTOMY DEVICE WAS LOADED ONTO THE VIPERWIRE GUIDE WIRE AND ADVANCED TO THE SITE OF TREATMENT. THE PHYSICIAN SUCCESSFULLY TREATED THE LESION USING THE OAD, BUT UPON REMOVAL OF THE OAD AND GUIDE WIRE, DISCOVERED THAT THE TIP OF THE GUIDE WIRE HAD SHEERED OFF AND WAS LEFT IN THE PATIENT. THE TIP OF THE WIRE WAS LOCATED IN A DISTAL COLLATERAL VESSEL AND WAS NOT RETRIEVED. THE PHYSICIAN COMPLETED THE INTERVENTION VIA BALLOON ANGIOPLASTY. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE OF THE FACILITY, BUT WERE DENIED.

  Patient problems: Foreign Body In Patient

  MAUDE report 5180250 ↗
• InjurySep 17, 2015Device Operates Differently Than Expected; Failure to Shut Off

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WOULD NOT SHUT OFF AND THE SALINE INFUSION PUMP HAD TO BE MANUALLY UNPLUGGED FROM THE WALL. ADDITIONALLY, A DISSECTION OCCURRED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS SEVERELY CALCIFIED, 90% STENOTIC AND 15MM IN LENGTH. IT WAS LOCATED IN THE PROXIMAL SFA WHICH HAD A REFERENCE VESSEL DIAMETER OF 5MM. THE PHYSICIAN USED A 6FR INTRODUCER SHEATH TO ACCESS THE LESION. A CSI VIPERWIRE GUIDEWIRE WAS ADVANCED ACROSS THE LESION AND THE OAD WAS LOADED ONTO IT. THE PHYSICIAN PERFORMED TWO SUCCESSFUL RUNS AT MEDIUM. DURING THE THIRD RUN AT MEDIUM SPEED, THE DEVICE BOGGED DOWN, BUT ATHERECTOMY WAS CONTINUED. DURING THE FOURTH RUN, THE DEVICE MADE AN UNUSUAL SOUND. WHEN THE PHYSICIAN ATTEMPTED TO TURN OFF THE OAD, THE POWER BUTTON WAS UNRESPONSIVE. THE SALINE INFUSION PUMP WAS UNPLUGGED FROM THE WALL. POST-ATHERECTOMY ANGIOGRAPHY REVEALED A DISSECTION IN THE SFA. THE PHYSICIAN RESOLVED THE DISSECTION BY DEPLOYING TWO STENTS. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. THREE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NONE HAS YET BEEN

  Patient problems: Vascular Dissection

  MAUDE report 5085096 ↗