Stealth DBE-150 (REF 70056-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10852528005015), received between Oct 13, 2015 and Aug 27, 2019 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Infusion or Flow Problem; Noise, Audible; Infusion or Flow Problem; Noise, Audible

  THE PERIPHERAL STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) MADE AN UNUSUAL SOUND WHEN IT WAS ACTIVATED TO PERFORM TREATMENT, AND BLOOD BACKED UP INTO THE SALINE TUBING. THE OAD WAS REMOVED FROM THE PATIENT AND REPLACED WITH A SECOND DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. THE TARGET LESION WAS LOCATED IN THE MID TO DISTAL SIDE OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 100 MILLIMETERS IN LENGTH WITH MODERATE CALCIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8937270 ↗
• MalfunctionDec 26, 2018Entrapment of Device; Separation Problem; Entrapment of Device; Separation Problem

  DURING A PROCEDURE, A DEVICE MALFUNCTION OCCURRED WITH THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). THE INITIAL TARGET LESION WAS A 100% STENOSED, 100MM IN LENGTH, IN THE ANTERIOR TIBIAL ARTERY WITH A DIAMETER OF 3.5 MM. THE INITIAL LESION WAS TREATED WITH MULTIPLE PASSES OF THE DEVICE. THE OAD BECAME STUCK ON THE GUIDE WIRE AND THE OAD AND GUIDE WIRE WERE REMOVED TOGETHER RESULTING IN LOSS OF WIRE ACCESS. RE-WIRING WAS PERFORMED FOR A SECOND LESION LOCATED IN THE POSTERIOR TIBIAL ARTERY, RESULTING IN A PROCEDURAL DELAY OF OVER 30 MINUTES. PRIOR TO ATHERECTOMY OF THE SECOND LESION, THE SHEATH COVERING THE DRIVESHAFT OF THE OAD WAS NOTED TO BE LOOSE. THE OAD WAS REMOVED, AND THE SECOND VESSEL WAS BALLOONED WITHOUT USING ATHERECTOMY. THERE WERE NO PATIENT COMPLICATIONS FROM THE PROCEDURE REPORTED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8197119 ↗
• InjuryAug 8, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE BECAME STUCK IN THE LESION. THE TARGET LESION WAS 90% STENOSED AND LOCATED IN THE DISTAL PEDAL ARTERY. FOLLOWING ONE PASS OF THE OAD ON LOW SPEED, THE DEVICE BECAME STUCK IN THE VESSEL. THE OAD WAS CUT AT THE NOSE CONE AND A NON-CSI EXCHANGE CATHETER WAS INSERTED AROUND THE CROWN TO REMOVE THE DEVICE. REMOVAL OF THE DEVICE RESULTED IN A ONE HOUR PROCEDURAL DELAY. NO ADDITIONAL TREATMENT WAS PERFORMED ON THE INITIAL LESION DUE TO VESSEL SPASM. BALLOON ANGIOPLASTY WAS PERFORMED ON A SECOND LESION IN THE LATERAL PLANTAR AREA AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Code Available; Vessel Or Plaque, Device Embedded In

  MAUDE report 7763989 ↗
• InjuryJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), AN EMBOLIZATION OCCURRED. ON (B)(6) 2017, A PERIPHERAL ATHERECTOMY WAS PERFORMED USING A CSI OAD. THE TARGET LESION WAS LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY AND WAS TREATED WITH THE OAD USING EIGHT PASSES FOLLOWED BY BALLOON ANGIOPLASTY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH WARMTH IN THE LEFT FOOT AND AN EMBOLIZATION WAS FOUND TO HAVE OCCURRED, RESULTING IN AMPUTATION OF THE THIRD TOE. THE CAUSE OF THE EMBOLIZATION WAS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Embolism

  MAUDE report 7209551 ↗
• InjuryOct 13, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A TYPE B DISSECTION OCCURRED DURING USE WITH A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS HIGHLY CALCIFIED AND LOCATED IN THE MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 95% STENOSIS. THE LESION WAS ACCESSED USING BALLOON INFLATION TO ASSIST IN INTRODUCING A 45CM COOK SHEATH TO REACH THE SFA. A CONTRALATERAL APPROACH WAS USED WITH BALLOON INFLATION OVER THE ILLIAC BIFURCATION IN ORDER TO GUIDE THE 45CM INTRODUCER SHEATH THROUGH TO THE TREATMENT AREA. THE CSI OAD WAS INTRODUCED TO THE SFA TO PERFORM ATHERECTOMY. THE PHYSICIAN PERFORMED MULTIPLE RUNS AT LOW, MEDIUM AND HIGH SPEEDS. THE PHYSICIAN THEN TREATED THE SFA WITH LOW PRESSURE BALLOON INFLATION USING A 6 X 15 CM BARD ULTRAVERSE BALLOON. ANGIOGRAPHY WAS THEN PERFORMED WHERE A POSSIBLE DISSECTION WAS NOTED ALONG WITH A LESION THAT WAS STILL 50% OCCLUDED. THE PHYSICIAN THEN PLACED A COOK ZILVER PTX 6 X 100 DRUG ELUTING SFA STENT AND POST DILATED THE STENT WITH A 6 X 80MM BALLOON. REPEAT ANGIOGRAPHY DEMONSTRATED FLOW WITH NO RESIDUAL. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 5144781 ↗