SilverHawkTM P4056Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684074169), received between Mar 23, 2018 and Nov 13, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE THE SILVERHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A SOFT TISSUE LESION, WITH LITTLE TORTUOSITY, NO CALCIFICATION AND 99% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY(SFA) AS PER IFU. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED AFTER TWO PASSES THE DEVICE JAMMED AND BECAME EXCESSIVELY DIFFICULT TO CLOSE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063633 ↗
• MalfunctionMar 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN USED A SILVERHAWK DEVICE DURING TREATMENT OF A SLIGHTLY CALCIFIED PLAQUE LESION IN THE LEFT MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS DESCRIBED AS SLIGHTLY TORTUOUS. THE LESION EXHIBITED 90% STENOSIS. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. FOLLOWING REMOVAL OF THE DEVICE AND WITH THE THUMBSWITCH IN THE CLOSED/OFF POSITION AND THE CUTTER WAS INSIDE OF THE HOUSING. IT WAS REPORTED THAT THE NOSECONE OF THE DEVICE APPEARED TO HAVE DETACHED FROM THE SHAFT AND NOT THE GUIDEWIRE LUMEN BUT THERE IS ACTUAL SEPARATION OF THE NOSECONE AND SHAFT OF THE DEVICE. NO DEFORMATION WAS REPORTED IN THE CUTTER. THE LESION WAS TREATED WITH A 5X40 BALLOON AND 6X40 STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7365198 ↗

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