SilverHawkTM P4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00821684074046), received between Jun 9, 2017 and Apr 20, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2018Material Deformation; Material Deformation

  PHYSICIAN USED A SILVERHAWK DEVICE DURING TREATMENT OF A 60MM MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID RIGHT POPLITEAL ARTERY OF DIAMETER 8MM. THE VESSEL WAS DESCRIBED AS HAVING LITTLE TORTUOSITY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED THAT DURING REMOVAL, THE WIRE PORT OF THE SILVERHAWK PEELED AWAY FROM THE CATHETER. THE WIRE WAS STUCK IN THE WIRE PORT AND THE CATHETER AND WIRE HAD TO BE REMOVED TOGETHER. NO PATIENT INJURY REPORTED. PATIENT HAS A HISTORY OF HYPERTENSION AND PERIPHERAL VASCULAR DISEASE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7446068 ↗
• MalfunctionDec 21, 2017Retraction Problem; Retraction Problem

  THE PHYSICIAN INTENDED TO USE THE SILVERHAWK DIRECTIONAL ATHETERCTOMY DEVICE AS PER IFU, TO TREAT A CTO IN THE SUPERFICIAL FEMORAL ARTERY. A NON-MEDTRONIC .014 300 GUIDEWIRE AND A 6 FR NON-MEDTRONIC SHEATH WERE USED. ARTERY DIAMETER 6MM LESION LENGTH 100MM. IT WAS REPORTED THE DEVICE WAS ADVANCED TO THE LESION, MADE 2 PASSES WITH NO ISSUES NOTED. DURING REMOVAL OF THE DEVICE THE PHYSICIAN ENCOUNTERED RESISTANCE, FLUORO IMAGE SHOWED A PROLAPSED WIRE IN PROXIMAL SFA AT THE DISTAL SECTION OF THE DEVICE. THE PHYSICIAN ADVANCED THE WIRE TO STRAIGHTEN. THE WIRE AND DEVICE WERE REMOVED INTACT AS A UNIT. THE WIRE WAS REMOVED FROM THE PROXIMAL PORT, A DEFORMITY WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137134 ↗
• MalfunctionNov 17, 2017Device Damaged by Another Device; Device Damaged by Another Device

  THE PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A 60MM MODERATELY CALCIFIED LESION IN THE MID SFA. THE ARTERY WAS 6MM IN DIAMETER HAD LITTLE TORTUOSITY. THE VESSEL WAS NOT PRE- OR POST-DILATED. THE SILVERHAWK WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 6 FR, 45CM NON-MEDTRONIC SHEATH AND A .014" NON-MEDTRONIC GUIDEWIRE. IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, THE CUTTER SPLIT THE WIRE. THE PHYSICIAN NOTICED THE SPLIT, NO DAMAGE WAS NOTED TO THE CUTTER. THE CUTTER COULD BE RETURNED TO THE HOUSING. THE PROCEDURE WAS COMPLETED USING AN EVERFLEX STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7043320 ↗
• MalfunctionSep 20, 2017Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  THE PHYSICIAN USED A SILVERHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A PLAQUE LESION IN THE RIGHT MID SFA. THE LESION WAS DESCRIBED AS HAVING LITTLE CALCIFICATION, 80 MM IN LENGTH WITH 80% STENOSIS. THE ARTERY WAS 6 MM IN DIAMETER WITH LITTLE TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A 0.014"NON-MEDTRONIC GUIDEWIRE WAS USED WITH A 6 FR NON-MEDTRONIC SHEATH. NO EMBOLIC PROTECTION WAS USED. IT WAS REPORTED UPON REMOVAL OF THE DEVICE, A WIRE WAS NOTED TO BE HANGING FROM THE WORKING PORTION OF THE DEVICE ALONG THE NOSECONE OR CUTTER WINDOW. NO RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT OR WITHDRAWAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881667 ↗
• MalfunctionJul 7, 2017Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY DEVICE FOR THE TREATMENT OF A 20 MM MODERATELY CALCIFIED, SLIGHTLY TORTUOUS LESION IN PROXIMAL LOCATION IN THE RIGHT POSTERIOR TIBIAL ARTERY OF DIAMETER 3.2 MM. LESION EXHIBITED 90% STENOSIS. THE DEVICE WAS INSPECTED BEFORE USE WITHOUT ISSUE. DEVICE IFU WAS FOLLOWED, AND PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT THE DEVICE WOULD NOT CROSS THE LESION AND THE CUTTER MOUTH WOULD NOT CLOSE ONCE THE PHYSICIAN SHAVED PROXIMAL TO IT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6692649 ↗
• MalfunctionJun 9, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS USING A SILVERHAWK BTK WITH A SIZE 6F NON-MEDTRONIC SHEATH AND A SIZE .014 NON-MEDTRONIC GUIDEWIRE FOR THE TREATMENT OF A MODERATELY CALCIFIED PLAQUE LESION IN THE LEFT PROXIMAL MID TIBIAL/POPLITEAL TRUNK WHICH EXHIBITED LITTLE TORTUOSITY AND 70-90% STENOSIS. THE IFU WAS FOLLOWED. DURING ADVANCEMENT OF THE SILVERHAWK INTO THE PT TRUNK/PERONEAL REGION, MODERATE RESISTANCE WAS MET. IT WAS REPORTED THAT WHEN PHYSICIAN ATTEMPTED TO ROTATE THE DEVICE AND OBSERVED THAT THE WIRE PORT CAME OUT THROUGH THE DISTAL PORTION OF THE DEVICE. THE WIRE PORT WHICH THE DEVICE IS ADVANCED OVER SHREDDED AND CAME OUT OF PLACEMENT. TIP SEPARATED AT THE HINGE PIN. NO DEVICE COMPONENT WAS LOST IN THE PATIENT. PROCEDURE WAS NOT COMPLETED. PHYSICIAN TERMINATED INTERVENTION OF THE VESSEL. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6628993 ↗

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