SilverHawk™ P4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169968462), received between Jul 25, 2019 and Jan 8, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

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

• MalfunctionJan 8, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN WAS USING SILVERHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT PROXIMAL COMMON ILIAC ARTERY WITH 90% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 30MM RESPECTIVELY. DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT A NON MEDTRONIC SHEATH WAS USED AND PLACED AT BIFURCATION, WOULD NOT GO TO RIGHT SIDE OF ILIAC ARTERY. THE SILVERHAWK WAS ADVANCED AND UPON MOVING OVER BIFURCATION, DEVICE WAS CAUGHT NEAR BIFURCATION AND WIRE LUMEN WITH THE WIRE WENT UP INTO AORTA. THE WIRE AND DEVICE WERE REMOVED WITHOUT ANY ISSUES. THE WHOLE DEVICE WAS INSPECTED WITH ALL PARTS PRESENT. THE LUMEN WAS STRIPPED FROM DEVICE AND A HAWKONE WAS USED AND PROCEDURE COMPLETED WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9563654 ↗
• MalfunctionDec 23, 2019Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY ALONG WITH NON-MEDTRONIC 6FR SHEATH AND NON-MEDTRONIC .014 GUIDE WIRE TO TREAT A VESSEL. THE VESSEL WAS NOT PRE DILATED. IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. THE GUIDE WIRE WAS HYDRATED AT PREPARATION. THE GUIDE WIRE DID NOT HAVE DIFFICULTY ACCESSING PORTS AND THE DEVICE WAS NOT ADVANCED OVER A BIFURCATION. IT WAS REPORTED THAT DURING ADVANCEMENT, MINIMAL RESISTANCE WAS FELT. THE GUIDE WIRE LUMEN WAS TORN FROM THE DISTAL TIP WHICH CAUSED GUIDE WIRE LOCK-UP ON CATHETER. UPON LOADING THE ATHERECTOMY CATHETER ON THE GUIDE WIRE, THE DEVICE HUNG UP ON THE WIRE NOT ALLOWING DEVICE TO ADVANCE ACROSS THE GUIDE WIRE. THE GUIDE WIRE WAS PULLED FROM LUMEN WITH RESISTANCE. THERE WAS NO DAMAGE TO THE GUIDEWIRE TIP. ANOTHER SILVERHAWK SS+ WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9509201 ↗
• MalfunctionDec 19, 2019Defective Device; Material Deformation; Defective Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT A LESION IN THE MID TIBIAL ARTERIES, AT, PT, AND PERONEAL. THE LESION HAD MODERATE CALCIUM. THE DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT THE CUTTER DRIVER STOPPED WORKING AND THE PHYSICIAN OPENED A NEW CUTTER DRIVER. THE DEVICE DID NOT START WITH THE NEW CUTTER DRIVER. THE PHYSICIAN REMOVED THE DEVICE TO FIND THE NOSECONE "SHREDDED". THE PHYSICIAN REPLACED THE DEVICE WITH A TURBOHAWK TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9496977 ↗
• MalfunctionJul 25, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A SILVERHAWK DEVICE TO TREAT A MODERATELY CALCIFIED, SEVERELY TORTUOUS SOFT TISSUE LESION IN THE MID LEFT TIBIAL/POPLITEAL TRUNK. A 6FR SHEATH AND A NON-MEDTRONIC(ASAHI, GLADIUS) 0.014 GUIDEWIRE WAS USED. THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 2-3MM & 8-9MM, RESPECTIVELY. THE IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. MODERATE RESISTANCE WAS FELT DURING ADVANCEMENT OF THE GUIDE WIRE; THE DEVICE WAS REPORTED TO HAVE BEEN TAKEN OFF WIRE AND THE GUIDEWIRE LUMEN HAD PROLAPSED. A NEW SILVERHAWK WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY, IT WAS NOTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8825684 ↗