SilverHawk™ P4028 (UDI 00763000918910)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000918910), received between May 7, 2026 and May 7, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Entrapment of Device; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT AN ATHERECTOMY PROCEDURE USING THE ATHERECTOMY P4028 SILVERHAWK BTK WAS ATTEMPTED TO TREAT A CALCIFIED TARGET LESION IN THE MID SEGMENT OF THE RIGHT POSTERIOR TIBIAL ARTERY WITH SEVERE CALCIFICATION, 90% STENOSIS, 20 MM LESION LENGTH, 3 MM VESSEL DIAMETER, AND MINIMAL TORTUOSITY. THE VESSEL WAS PRE-DILATED USING A 2 X 20 NANOCROSS DILATION DEVICE, EMBOLIC PROTECTION WAS NOT USED, AND THE DEVICE WAS ADVANCED OVER A COMMAND 014 GUIDEWIRE WITH A FLEXOR CHECK-FLO 5 FR INTRODUCER SHEATH IN PLACE. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE GUIDEWIRE WAS REPORTED TO HAVE RIPPED THROUGH THE WHITE WIRE LUMEN ON THE NOSECONE, CAUSING THE WIRE TO WRAP AROUND THE NOSECONE AND MANGLE THE DEVICE. THE DEVICE WAS THEN PULLED WITH RESISTANCE AND REMOVED SUCCESSFULLY IN TANDEM. THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED ALIVE WITH NO HEALTH CONSEQUENCES OR IMPACT, AND NO VESSEL DAMAGE, INJURY, OR INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25109168 ↗