SilverHawk™ P4056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169968448), received between Sep 26, 2018 and Sep 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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. 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.

• MalfunctionSep 26, 2018Mechanical Jam; Mechanical Jam

  THE PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK ATK WITH A PROTÉGÉ EF AS PER THE IFU TO TREAT A FIBROUS LESION WITH A SMALL DEGREE OF CALCIFICATION AND WITH 80% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENTS ANATOMY. THE LESION HAD A LENGTH OF 200MM AND THE ARTERY HAD A DIAMETER OF 5MM. THE PROCEDURE USED A NON MEDTRONIC 7FR SHEATH AND AN EV3 NITREX 0.014 300CM GUIDEWIRE. THE LESION WAS PREDILATED WITH A 5 X 150MM DEVICE. THE DEVICE WAS PREPPED WITH NO ISSUED IDENTIFIED. IT WAS REPORTED THAT THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS REPORTED WHEN ADVANCING THE DEVICE NOR WAS EXCESSIVE FORCE USED. IT WAS REPORTED THE PACKING MECHANISM OF THE SILVERHAWK JAMMED AND WOULD NOT CLOSE. THE BLADE RETURNED INTO THE HOUSING BEFORE IT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN REPORTED THAT A 7 X 120 EVERFLEX STENT WAS ADVANCED OVER THE WIRE TO THE TARGET LESION. THE MD DETERMINED THE STENT HE REQUESTED WAS TOO LONG AND WAS HE NOT COMFORTABLE DEPLOYING THIS STENT. HE SUBSEQUENTLY REMOVED THE UNDEPLOYED 7 X120 STENT AND REPLACED IT WITH A 7 X100 EVERFLEX STENT. AFTER SEEING THE 7 X 100 STENT UNDE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7909169 ↗