SilverHawkTM P4052Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00821684074121), received between Jun 14, 2017 and Apr 5, 2019 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K061188); they may or may not involve this specific model.

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

• MalfunctionApr 5, 2019Use of Device Problem; Use of Device Problem

  THE PHYSICIAN WAS USING A SILVERHAWK TO TREAT A CALCIFIED FIBROUS SOFT TISSUE LESION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER OF 6MM AND VESSEL WAS A LITTLE TORTUOUS. THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT IT WAS HARD TO CLOSE THE DEVICE AFTER INITIAL PASS AND THE DEVICE WOULD NOT ACTIVATE A SECOND TIME. THE CUTTER MOUTH WOULDN¿T OPEN AND THE THUMBSWITCH WOULD NOT ENGAGE. THERE WERE NO ISSUES SWITCHING THE MOTOR ON/OFF . NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS USED AFTER THE USE BY DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486116 ↗
• MalfunctionDec 4, 2018Mechanical Problem; Mechanical Problem

  THE PHYSICIAN INTENDED TO USE THE SILVERHAWK WITH A 7F NON-MEDTRONIC SHEATH AND A SPIDER FX 6MM, TO TREAT A 150MM SOFT TISSUE LESION WITH 80-90% STENOSIS IN THE SUPERFICIAL AND POPLITEAL ARTERY. ARTERY DIAMETER 5MM. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES NOTED. THE VESSEL WAS NOT PRE-DILATED AND NO RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THE TIP OF THE SILVERHAWK BECAME DAMAGED BUT DID NOT COMPLETELY DETACH. THIS OCCURRED WHERE THE SHAFT MEETS THE CUTTER. THE PHYSICIAN OPENED A SECOND SILVERHAWK DEVICE. IT WAS REPORTED THAT THE THUMB SWITCH WAS STICKING AND COULD NOT BE PUSHED ALL THE WAY FORWARD. IT IS UNKNOWN IF THE CUTTER RETURNED TO THE HOUSING FOR REMOVAL OF THE DEVICE, BUT IT WAS REMOVED SAFELY. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SECOND DEVICE. NO DEFORMATION WAS NOTED IN THE CUTTER WHEN REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8127926 ↗
• MalfunctionNov 23, 2018Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  THE PHYSICIAN INTENDED TO USE THE SILVERHAWK WITH A 7F NON-MEDTRONIC SHEATH AND A SPIDER FX 6MM, TO TREAT A SOFT TISSUE LESION WITH 80-90% STENOSIS IN THE LEFT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES. ARTERY DIAMETER 5MM, LESION LENGTH 150MM, DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES NOTED. THE VESSEL WAS NOT PRE-DILATED, NO RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THE TIP OF THE SILVERHAWK DETACHED; THE CUTTER HOUSING PARTED FROM THE SHAFT. THE PHYSICIAN OPENED A SECOND SILVERHAWK AND REPORTED THAT THE THUMB SWITCH WAS STICKING AND COULD NOT BE PUSHED ALL THE WAY FORWARD. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SECOND DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8099854 ↗
• InjuryMay 3, 2018Device Operational Issue; Device Operational Issue

  THE PHYSICIAN USED A SILVERHAWK DEVICE FOR THE TREATMENT OF A MODERATELY CALCIFIED LESION EXHIBITING 95% STENOSIS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT REPORTED TO BE TORTUOUS. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. IT IS REPORTED AFTER COMPLETING 4 PASSES, THE THUMBSWITCH BECAME STUCK IN THE ON POSITION. THE CUTTER WAS OUTSIDE OF THE HOUSING WHEN IT CRASHED BUT WAS ABLE TO GET INSIDE THE HOUSING WHEN THE TECH HELD FORWARD PRESSURE ON THE THUMBSWITCH AFTER THE POWER WAS TURNED OFF TO REMOVE THE DEVICE SAFELY FORM THE PATIENT. NO DEFORMATION WAS NOTED TO THE DEVICE ON REMOVAL FROM THE PATIENT. FOLLOWING REMOVAL, THE THUMBSWITCH REMAINED IN THE ON POSITION AFTER CLEANING THE DEVICE PREVENTING THE PHYSICIAN FROM MAKING ANY MORE PASSES. NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING STENTING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7482413 ↗
• MalfunctionApr 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY CATHETER TO TREAT A PLAQUE LESION WITH LITTLE CALCIFICATION IN THE PROXIMAL SFA-POPLITEAL ARTERY (80% STENOSIS). THE ARTERY WAS NON-TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS NOT PRE OR POST DILATED. DURING THE INITIAL ADVANCEMENT SEVERE RESISTANCE WAS ENCOUNTERED. THE BLADE OF THE DEVICE COULD NOT BE RELEASED. THE TIP OF THE DEVICE EMBOLISED AND WAS CAPTURED WITHIN THE SHEATH. A NEW SILVERHAWK WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395126 ↗
• InjuryMar 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING A SILVERHAWK WITH A NON-MDT 7 FR SHEATH AND NON-MDT 0.014 GUIDEWIRE FOR THE TREATMENT OF A SLIGHTLY CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) PLAQUE LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS PREPPED AS PER IFU. THE VESSEL WAS NOT PRE OR POST DILATED. THE VESSEL WAS REPORTED TO BE SLIGHTLY TORTUOUS. IT IS REPORTED THAT MODERATE RESISTANCE WAS EXPERIENCED DURING WITHDRAWAL. THE TIP SEPARATED AT THE HINGE PIN AND THE NOSECONE TWISTED OFF. THE PATIENT WENT FOR SURGERY TO REMOVE THE DETACHED PORTION WHICH HAD OCCLUDED THE VESSEL. THE PATIENT IS REPORTED TO BE FINE.

  Patient problems: Device Embedded In Tissue or Plaque; Occlusion

  MAUDE report 7333513 ↗
• MalfunctionJun 14, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PHYSICIAN USED THE SILVERHAWK ATK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED THE SILVERHAWK WAS USED TO TREAT AN IN-STENT RESTENOSIS (ISR), THE PHYSICIAN WAS INFORMED THAT THE SILVERHAWK IS CONTRAINDICATED FOR ISR, BUT ELECTED TO USE THE DEVICE FOR THIS PROCEDURE. DURING THE PROCEDURE THE SIVERHAWK BECAME STUCK ON A STENT STRUT, THE REP WAS CALLED INTO THE ROOM. THE SILVERHAWK WAS TURNED OFF; THE CUTTER WINDOW WAS LEFT OPEN. THE PHYSICIAN ATTEMPTED TO TORQUE THE SILVERHAWK TO FREE THE DEVICE FROM THE STENT STRUT BUT WAS UNABLE TO DO SO. THE SILVERHAWK WAS PULLED BACK AND EVENTUALLY DISLODGED FROM THE STENT CUTTING THROUGH A STENT STRUT AS IT WAS BEING REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641257 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061188. One submission often covers many models, so check the product and lot details in each record.

• Z-1162-2010 · Jan 21, 2010 · Terminated
  SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 554