SilverHawkTM P4028Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684074039), received between Apr 4, 2017 and Apr 4, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2017Detachment Of Device Component; Material Fragmentation; Detachment Of Device Component; Material Fragmentation

  PHYSICIAN WAS ATTEMPTING TO TREAT A FIBROUS LESION IN THE TIBIAL/POPLITEAL TRUNK USING SILVERHAWK ATHERECTOMY DEVICE. IT WAS REPORTED THAT THE NOSE CONE OF THE ATHERECTOMY DEVICE WAS SHEARED OFF INSIDE PATIENT ARTERY AND COULD NOT BE REMOVED WITH SNARE. PATIENT HAD TO GO TO OPERATING ROOM (OR) TO GET THE NOSE CONE REMOVED. THE PATIENT WAS DOING WELL POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6459106 ↗

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