STEALTH PRD-MAX-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10850026568711), received between Sep 2, 2022 and Aug 12, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Difficult to Remove; Difficult to Remove

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SUCCESSFULLY ADVANCED THROUGH THE 6 X 45 SHEATH WITH NO RESISTANCE MET. SIX LOW SPEED TREATMENTS WERE PERFORMED DOWN THE ENTIRETY OF A HEAVILY CALCIFIED, 30-40% STENOSED, 5MM LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS UNCOMFORTABLE DURING THE TREATMENT. POST-TREATMENT, THE OAD WAS ATTEMPTED TO BE REMOVED FROM THE PATIENT WHEN RESISTANCE WAS MET AT THE DISTAL PART OF THE SHEATH. THE OAD CONTROL KNOB WAS IN LOCKED POSITION AND THE CROWN WAS NOT MOVING IN EITHER DIRECTION. THE SHEATH WAS FLUSHED AND NO MOVEMENT CONTINUED. A BUDDY WIRE WAS USED IN AN ATTEMPT TO DISLODGE THE OAD CROWN. THE OAD WAS ABLE TO BE REMOVED AFTER THE BUDDY WIRE WAS ABLE TO DISLODGE THE OAD CROWN. THE PHYSICIAN DID NOT OBSERVE ANY ISSUES WITH THE WIRE AND THE OAD.

  Patient problems: Discomfort

  MAUDE report 19960773 ↗
• MalfunctionMay 22, 2023Material Separation; Material Separation

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT COMMON FEMORAL ARTERY. AS THE OAD WAS ADVANCED, A HIGH PITCH NOISE WAS HEARD AND THE OAD STOPPED ADVANCING THROUGH THE LESION. THE OAD WAS ATTEMPTED TO BE ADVANCED THREE TIMES BEFORE THE PHYSICIAN STOPPED THE PROCEDURE TO EVALUATE THE OAD. THE SALINE SHEATH APPEARED TO BE SEPARATED, BUT NOT DETACHED. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973892 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA), WHICH HAD SOFT CALCIUM. THE OAD WAS SPUN ON LOW SPEED FOR THREE TREATMENTS AND THEN SPUN ON MEDIUM SPEED. THE PATIENT EXPRESSED PAIN AND THE OAD PRODUCED AN UNUSUAL NOISE. AT THIS TIME, THE PHYSICIAN FELT THE OAD "BUCKLED" AND THEREFORE REMOVED THE OAD. INTRAVASCULAR ULTRASOUND (IVUS) WAS REVIEWED, AND NO DISSECTION WAS OBSERVED. THE OAD WAS REMOVED, AND TISSUE WAS OBSERVED ON THE DRIVESHAFT. BASED ON THIS, THE PHYSICIAN BELIEVED A DISSECTION MAY HAVE OCCURRED AT THE OSTIUM OF THE VESSEL. ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Intraoperative Pain; Vascular Dissection

  MAUDE report 16964874 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A MID-SUPERFICIAL FEMORAL ARTERY (SFA) OF A 5 CM MIXED MORPHOLOGY LESION. THERE WAS A THREE-VESSEL RUNOFF, ALL OF WHICH HAD EMBOLISMS, AND TWO VESSELS WERE OCCLUDED. TISSUE PLASMINOGEN ACTIVATOR (TPA), NITROGLYCERIN, AND MANUAL ASPIRATION WERE USED TO RESOLVE THE EVENT.

  Patient problems: Embolism/Embolus

  MAUDE report 16707619 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEALTH 360 ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE OAD WAS ADVANCED OVER THE VIPERWIRE ADVANCE GUIDE WIRE TO CROSS THE LESION. A DISTAL SLOW FLOW AND DISSECTION WERE OBSERVED AND RESOLVED AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED ON THE DISTAL VESSEL. NITROGLYCERIN AND ADENOSINE WERE ADMINISTERED. THE PHYSICIAN STATED THEY SHOULD HAVE REPOSITIONED THE WIRE BEFORE PLACING THE OAD CROWN PROXIMAL TO THE LESION. IN THE PHYSICIAN'S OPINION, THE CAUSE OF THE DISSECTION WAS DUE TO THE CROWN BEING ADVANCED THROUGH THE LESION WHILE NOT BEING TURNED ON. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 16404512 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTRAVASCULAR ULTRASOUND (IVUS) OF THE VESSELS REVEALED MIXED MORPHOLOGY PLAQUE. ATHERECTOMY WAS PERFORMED IN THE LEFT COMMON FEMORAL ARTERY (CFA), SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). ACCESS WAS GAINED IN THE CFA WITH A 6FR CATHETER. TWO 20 SECOND TREATMENTS WERE PERFORMED ON LOW SPEED, FOLLOWED BY TWO 20 SECOND TREATMENTS ON MEDIUM SPEED IN THE POPLITEAL ARTERY WITH 30 SECOND BREAKS BETWEEN TREATMENTS. VASODILATORS WERE ADMINISTERED FOLLOWING EACH TREATMENT. IVUS WAS PERFORMED AND REVEALED A SPIRAL, FLOW LIMITING DISSECTION FROM THE CFA TO THE MID SFA. BALLOON ANGIOPLASTY WAS PERFORMED. A STENT WAS DEPLOYED AND COVERED THE DISSECTION. IVUS WAS PERFORMED AND REVEALED THE DISSECTION TO HAVE RESOLVED. FOLLOWING THE PROCEDURE, THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 15931680 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED FOR TREATMENT TWENTY TIMES AT TWENTY SECONDS. THE PROCEDURE WENT WELL WITH NO COMPLICATIONS. POST OPERATION, THE PATIENT EXPERIENCED DARK URINE DUE TO MECHANICAL DAMAGE OF RED BLOOD CELLS DURING THE PROCEDURE. THE HEMOGLOBINURIA WAS SUSPECTED TO BE CAUSED BY THE DEVICE. THE PATIENT WAS GIVEN EXTRA FLUIDS TO RESOLVE THE HEMOGLOBINURIA. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 15347987 ↗