SilverHawkTM P4055Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684074145), received between May 17, 2017 and Dec 7, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2018Mechanical Problem; Mechanical Problem

  THE PHYSICIAN USED A SILVERHAWK DEVICE TO TREAT A SOFT TISSUE LESION WITH LITTLE DEGREE OF CALCIFICATION AND 90% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL PRESENTED LITTLE TORTUOSITY. THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED WITH NO ISSUED IDENTIFIED. IFU WAS FOLLOWED. IT WAS REPORTED THAT AFTER ONE INSERTION AND EIGHT PASSES, THE THUMBSWITCH BECAME JAMMED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141042 ↗
• InjuryJul 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN ATTEMPTED TO USE A SILVERHAWK WITH A NON-MEDTRONIC SHEATH AND GUIDEWIRE AS PER THE IFU TO TREAT A PLAQUE LESION WITH LITTLE CALCIFICATION AND LITTLE TORTUOSITY WITH 75% STENOSIS IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER AND LENGTH WERE 6MM AND 100MM RESPECTIVELY. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THE TIP DETACHED DURING ADVANCEMENT. THE WIRE LUMEN COVERING BECAME DETACHED DURING ADVANCEMENT OF THE CATHETER OVER ILIAC BIFURCATION, MODERATE RESISTANCE WAS FELT. IT WAS ALSO REPORTED THAT DURING ADVANCEMENT OF THE CATHETER OVER THE ILIAC BIFURCATION RESISTANCE WAS FELT, MORE PRESSURE WAS APPLIED BUT APPARENTLY THE CATHETER BECAME STUCK AND CAUSED THE SHEATH TO PROLAPSE INTO THE AORTA. AS THE PHYSICIAN WAS TRYING TO REMOVE THE CATHETER FROM THE SHEATH THE WIRE LUMEN COVERING PORTION BECAME COMPLETELY DETACHED AND ENDED UP BEING DEPOSITED IN THE LEFT COMMON FEMORAL ARTERY AREA. THE LESION TREATED WAS THE DISTAL RIGHT SFA. THE PATIENT WAS REPORTED TO BE STABLE DURING THE PROCEDURE. AN ATTEMPT WAS MADE TO SNARE THE PIECE OF WIRE LUMEN COVERING, THAT BECAME LODGED IN T

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 7662327 ↗
• MalfunctionJun 28, 2017Break; Break

  PHYSICIAN WAS USING A SILVERHAWK DEVICE FOR AN ATHERECTOMY PROCEDURE OF A FIBROUS LESION IN THE LEFT PROXIMAL SFA WITH 80% STENOSIS. THE DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THERE WAS DIFFICULTY IN FLUSHING THE TISSUE OUT OF THE NOSECONE. PROBE WAS UNABLE TO PUSH OUT THE TISSUE. THE PROCEDURE WAS COMPLETED USING A NEW TURBOHAWK DEVICE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6676027 ↗
• MalfunctionMay 17, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY CATHETER DURING PROCEDURE. A 7FR 45CM SHEATH AND .014 GUIDEWIRE FOR THE TREATMENT OF A MODERATELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY WHICH DISPLAYED A MODERATE DEGREE OF TORTUOSITY. THE DEVICE WAS PREPPED AS PER IFU. MINIMAL RESISTANCE WAS FELT DURING ADVANCEMENT. THE TIP DETACHED AT THE HINGE PIN DURING ADVANCEMENT OF DEVICE THROUGH SHEATH. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574202 ↗

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