SilverHawk™ P4055Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169968431), received between Dec 4, 2018 and Feb 8, 2021 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2021Incomplete or Missing Packaging; Detachment of Device or Device Component; Incomplete or Missing Packaging; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS LITTLE TORTUOUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT PATIENT HAD DISEASE IN THE SFA ALONG WITH IN-STENT RESTENOSIS. THE PHYSICIAN WANTED TO HAWK WITHIN THE STENT, KNOWING THAT THIS IS AN OFF LABEL PRACTICE AND NOT ADVISED BY MEDTRONIC REPS. PHYSICIAN CHOSE TO CONTINUE AT OWN DISCRETION. PHYSICIAN HAD DONE THIS OFF LABEL PRACTICE BEFORE AND FELT COMFORTABLE PROCEEDING. THE NOSECONE GOT CAUGHT ON THE STENT. PHYSICIAN TRIED TURNING IT OFF, TRIED ROTATING NOSECONE SO IT WOULD RELEASE FROM THE PART OF THE STENT IT WAS CAUGHT ON. VARIOUS DIFFERENT TECHNIQUES WERE TRIED TO FREE THE STENT FROM THE NOSECONE. ADDITIONALLY, PHYSICIAN ATTEMPTED INSERTING A BUDDY WIRE AND FOLLOWED BY BALLOON, BUT BALLOON WOULD NOT PASS. PHYSICIAN TRIED TO MOVE THE CATHETER UP AND DOWN AND ROTATE THE NOSECONE BUT IT WAS CAUGHT. THE NOSECONE ENDED UP BREAKING OFF FROM THE CATHETER. THE SILVERHAWK CATHETER WAS REMOVED AND THEN JAILED THE DET

  Patient problems: Foreign Body In Patient

  MAUDE report 11292530 ↗
• InjurySep 5, 2019Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  PHYSICIAN USED AN SILVERHAWK LXM TO TREAT A FIBROUS/SOFT TISSUE LESION WITH MODERATE DEGREE OF TORTUOSITY AND CALCIFICATION, PRESENTING CTO (CHRONIC TOTAL OCCLUSION -100%) IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER AND LESION LENGTH WERE 6MM AND 80 MM RESPECTIVELY. THE DEVICE WAS INSPECTED AND PREPARED AS PER THE IFU WITH NO ISSUES IDENTIFIED. PATIENT HAD A PRIOR STENT DEPLOYED IN LEFT SFA. THE SILVERHAWK WAS ADVANCED THROUGH THE LEFT PROXIMAL SFA/ COMMON FEMORAL ARTERY WHERE MULTIPLE PASSES WAS PERFORMED. THE DEVICE WAS REMOVED AND A 6X80 CHOCOLATE BALLOON WAS USED F. THE BALLOON WAS REMOVED AND ANGIOGRAM WAS PERFORMED USING A NON-MEDTRONIC (NAVICROSS) CATHETER. THE SILVERHAWK LXM WAS RE-ADVANCED FOR ADDITIONAL PASSES. DURING THE ADDITIONAL PASSES, IT WAS REPORTED THAT THE DEVICE GOT STUCK ON THE STENT STRUTS OF THE PREVIOUSLY DEPLOYED STENT IN THE LEFT SFA. THE SILVERHAWK WAS TURNED OFF AND MULTIPLE ATTEMPTS TO REMOVE THE SILVERHAWK WERE PERFORMED WITH NO SUCCESS. A NON-MEDTRONIC SHEATH (7X90 DESTINATIONS TERUMO ) AND A 3.5X30 SPRINTER BALLOON WERE USED IN ATTEMPT TO REMOVE THE SILVERHAWK FROM THE PATIENT'S VASCULATURE, UNSUCCESSFULLY. ANOTHER ANGIOGRA

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8964183 ↗
• MalfunctionAug 13, 2019Difficult to Flush; Mechanical Jam; Difficult to Flush; Mechanical Jam

  PHYSICIAN USED A SILVERHAWK DEVICE WITH A 7FR SHEATH AND 0.014 WIRE DURING TREATMENT OF A FIBROUS LESION IN THE PATIENT¿S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). NO TORTUOSITY OR CALCIFICATION REPORTED. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED. IT IS REPORTED THAT DURING THE PROCEDURE, DIFFICULTY WAS EXPERIENCED WHEN TRYING TO FLUSH TISSUE. THE THUMB SWITCH ON THE CUTTER DRIVER WOULD FULLY TRANSITION INTO THE ON AND OFF POSITIONS. THE CUTTER DRIVER WAS RELEASED FROM THE CATHETER AND REATTACHED. A NEW CUTTER DRIVER WAS THEN CONNECTED. DUE TO THE INABILITY TO FULLY OPEN AND CLOSE THE CUTTER WINDOW DUE TO THE THUMB SWITCH, PLAQUE WAS NOT ABLE TO BE FLUSHED FROM THE NOSECONE. NO DAMAGE NOTED TO DEVICE. A SECOND ATHERECTOMY DEVICE AS OPENED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887204 ↗
• MalfunctionJul 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A SILVERHAWK ATK DEVICE DURING TREATMENT OF A 50 MM CALCIFIED 70% STENOTIC LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6 MM. NO TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. THE DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. IT WAS REPORTED THAT DEVICE BROKE AND THE NOSECONE SEPARATED JUST DISTAL TO THE CUTTER WINDOW. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784225 ↗
• MalfunctionApr 10, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED USE A SILVERHAWK TO TREAT A 40MM SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE MID LEFT COMMON FEMORAL ARTERY. MODERATE TORTUOSITY WAS REPORTED IN THE 7MM DIAMETER ARTERY. A 7FR NON MEDTRONIC SHEATH AND A 5MM SPIDERFX WAS USED IN THE PROCEDURE. THE VESSEL WAS PRE-DILATED. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO FLUSH TISSUE FROM THE DEVICE DURING CLEANING. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT MODERATE RESISTANCE WAS FELT DURING WITHDRAWAL OF THE DEVICE AND THAT THE NOSE CONE TIP DETACHED FROM THE DEVICE AT THE HINGE PIN. THE DETACHED TIP WAS REMOVED FROM THE PATIENT AND SUCCESSFULLY CLEANED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8498888 ↗
• MalfunctionMar 26, 2019Mechanical Problem; Mechanical Problem

  THE PHYSICIAN WAS USING A SILVERHAWK TO TREAT A MODERATELY CALCIFIED PLAQUE CTO IN THE RIGHT PROXIMAL/MID/DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE TORTUOSITY WAS REPORTED. A NON MEDTRONIC 7FR 45CM SHEATH AND A NON MEDTRONIC 0.035 180CM STIFF GUIDEWIRE WERE USED IN THE PROCEDURE. THE IFU WAS FOLLOWED. AFTER THE FIRST PASS THE DEVICE WAS REMOVED FROM THE PATIENT. THE THUMBSWITCH WOULD NOT ADVANCE FORWARD AND THE DEVICE WOULD NO LONGER PACK. A NEW SILVERHAWK DEVICE AND DRIVER WERE USED TO COMPLETE THE PROCEDURE WITH A GOOD RESULT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451092 ↗
• MalfunctionFeb 26, 2019Mechanical Problem; Mechanical Problem

  PHYSICIAN WAS TREATING A LESION IN THE MID COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY WITH A SILVERHAWK ATHERECTOMY DEVICE. THE LESION WAS FIBROUS CTO LESION WITH SEVERE TORTUOSITY AND LITTLE CALCIFICATION. THE ANATOMY WAS DESCRIBED AS HAVING A VERY ACUTE ANGLE AORTO ILIAC BIFURCATION. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE JAMMED AND WOULD NOT CLOSE. ANOTHER SILVERHAWK DEVICE WAS USED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369560 ↗
• MalfunctionJan 21, 2019Mechanical Problem; Mechanical Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DEVICE. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES. IT WAS REPORTED THAT AFTER MULTIPLE PASSES THROUGH A MODERATELY CALCIFIED LESION WITH 50% STENOSIS AT THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THE THUMB SWITCH WOULD NOT ADVANCE TO CLOSE THE BLADE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264020 ↗
• MalfunctionDec 4, 2018Mechanical Problem; Mechanical Problem

  THE PHYSICIAN INTENDED TO USE A SECOND SILVERHAWK TO TREAT A FIBROUS LESION IN THE RIGHT-MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL PRESENTED LITTLE TORTUOSITY AND 50% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITHOUT ISSUES NOTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUES IDENTIFIED. IT IS REPORTED THIS DEVICE WAS JAMMED AND WOULD NOT CLOSE. THE CUTTER COULD NOT BE RETURNED TO THE HOUSING. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO VISIBLE DEFECTS WERE NOTED. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8128044 ↗