SilverHawk™ P4028 (UDI 00643169968455)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169968455), received between Dec 10, 2018 and Jan 27, 2023 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Difficult to Advance; Difficult to Advance

  A PHYSICIAN WAS ATTEMPTING TO USE A SLIVERHAWK ATHERECTOMY DEVICE FOR THE TREATMENT OF A PLAQUE LESION IN THE PROXIMAL REGION IN THE COMMON ILIAC ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS ADVANCED OVER AN .014 WIRE WITH RESISTANCE THROUGH A 6FR DESTINATION CONTRALATERAL SHEATH. THE RESISTANCE BECAME MORE SEVERE WHILE ADVANCING ONCE THE DEVICE CAME OUT THE DISTAL END OF THE SHEATH, AND WIRE WRAP OCCURRED, CAUSING THE WIRE TO LOOP. ATTEMPTS WERE MADE BY THE PHYSICIAN TO CORRECT THE WIRE LOOP AND UNWRAP THE DEVICE AROUND THE WIRE, WITHOUT SUCCESS. ATTEMPTS WERE THEN MADE TO REMOVE THE DEVICE SAFELY WITHOUT LOSING WIRE AND SHEATH ACCESS. DUE TO THE SEVERITY OF WIRE WRAP AND WIRE BUCKLING, THE DEVICE, WIRE, AND SHEATH WERE ALL REMOVED FROM THE RIGHT CFA ACCESS SITE, WITHOUT ANY FOREIGN BODIES LEFT IN THE PATIENT. MANUAL PRESSURE WAS HELD SUCCESSFULLY TO THE ACCESS SITE UNTIL ADEQUATE HEMOSTASIS WAS ACHIEVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE BY ACCESSING THE LEFT CFA IN ANTEGRADE APPROACH. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IT WAS NOTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252321 ↗
• MalfunctionMar 30, 2022Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE SILVERHAWK BTK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE PROXIMAL TO MID POSTERIOR TIBIAL ARTERY (PTA) TO ANTERIOR TIBIAL ARTERY (ATA) WITH 30% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT A BREAK OCCURRED WHERE THE WIRE CAME OUT OF SIDE OF NOSE CONE. UNSURE IF THERE WAS A DAMAGE TO THE TECOTHANE. THE PLAQUE DID NOT EMBOLIZE DUE TO THE EVENT. THE TIP/NOSE CONE DID NOT DETACH FROM HINGE PIN. THERE WAS NO VESSEL DAMAGE DUE TO EVENT. THE LESION WAS TREATED WITH A BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13947873 ↗
• MalfunctionMar 2, 2022Peeled/Delaminated; Peeled/Delaminated

  PHYSICIAN WAS ATTEMPTING TO USE THE SILVERHAWK ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT PLAQUE IN THE MID LEFT TIBIAL/POPLITEAL TRUNK. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE WAS INSPECTED WITH ISSUES NOTED. UPON REMOVAL OF THE CATHETER PHYSICIAN NOTICED NEAR THE PROXIMAL WIRE EXIT PORT AT THE RAPID EXCHANGE THE WHITE PORTION OF THE CATHETER WAS PEELING AND MISTOOK IT AS PLAQUE REMOVED FROM THE VESSEL AND SO PULLED ON IT. UPON FURTHER INSPECTION NOTICED IT WAS THE WHITE COATING ON THE SHAFT NEAR THE PROXIMAL WIRE EXIT PORT THAT WAS PEELING. IT IS UNKNOWN WHETHER IT IS THE PET LINER OR HYDROPHILIC COATING. THE DEVICE WAS NOT WIPED DOWN PRIOR OR IN BETWEEN USES. THE PEELING OCCURRED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. A NON MEDTRONIC 0.014¿ WIRE WAS USED. THERE WERE NO ISSUES WITH PATIENT AND NOTHING WAS LEFT IN PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653239 ↗
• MalfunctionAug 26, 2021Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE THE SILVERHAWK ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE MID LEFT TIBIAL/POPLITEAL TRUNK WITH 100% CHRONIC TOTAL OCCLUSION(CTO).THE VESSEL WAS MODERATELY TORTUOUS AND WAS 2-3MM IN DIAMETER. THE LESION LENGTH WAS 10-12MM. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE GUIDEWIRE LUMEN BEGAN TO TEAR OR DISLODGE. THE TECOTHANE JACKET WAS TORN OPEN. NO GUIDEWIRE PROLAPSE NOTED. THE LUMEN DID NOT DISLODGE FROM SILVERHAWK. THE CUTTER WAS INSIDE THE HOUSING UNIT DURING REMOVAL FROM PATIENT. THE DEVICE WAS EASILY REMOVED FROM PATIENT. NO DETACHMENT WAS VISIBLE. NO INTERVENTION REQUIRED FOR REMOVAL. ARTERY WAS BALLOONED WITH NANOCROSS PTA BALLOON TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369253 ↗
• InjuryJun 8, 2021Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN ATTEMPTED TO USE A SILVERHAWK ATHERECTOMY DEVICE WITH AN 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 95% STENOSIS. THE DEVICE WAS INSPECTED WITHOUT ISSUE. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT THE NON-MEDTRONIC GUIDEWIRE WRAPPED AROUND THE DISTAL NOSECONE OF THE CATHETER UPON ATTEMPTING TO REMOVE THE CATHETER. THE PHYSICIAN HAD TO PULL THE WIRE, ATHERECTOMY CATHETER, AND SHEATH OUT AT ONE TIME. IT CAUSED THE .014 NON-MEDTRONIC WIRE TO BREAK OFF ON THE DISTAL END. THE DISTAL TIP DETACHED FROM THE SILVERHAWK CATHETER. THE DISTAL TIP WAS TORN OFF. THE CUTTER WAS INSIDE THE HOUSING DURING REMOVAL FROM PATIENT. A SNARE WAS USED TO REMOVE THE DETACHED PIECE AND GUIDEWIRE. THE PHYSICIAN PULLED THE REMAINING .014 WIRE OUT OF THE BODY. NO VESSEL DAMAGE NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11956723 ↗
• InjuryFeb 6, 2020Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Physical Resistance/Sticking; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Physical Resistance/Sticking

  PHYSICIAN INTENDED TO USE A SILVERHAWK ATHERECTOMY DEVICE AND NITREX GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA)/TIBIAL ARTERY OF DIAMETER 6MM. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION IS REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. LESION LOCATED IN THE PATIENT¿S TIBIAL VESSEL. TREATMENT WITH THE ATHERECTOMY DEVICE WAS SUCCESSFUL. RESISTANCE WAS NOTED WHEN ATTEMPTING TO REMOVE THE DEVICE. FLUOROSCOPIC VISUALIZATION OF THE DEVICE SHOWED THAT THE NITREX WIRE WAS LOOPED IN THE ILIAC ARTERY. WHEN THE DEVICE WAS PULLED WITH MORE FORCE, THE TIP BROKE FREE, BUT REMAINED ON THE WIRE. WHEN AN ATTEMPT TO SNARE FAILED, THE OPERATOR DECIDED TO SURGICALLY REMOVE THE DEVICE AND PERFORM AN ENDARTERECTOMY OF THE CFA AND PROXIMAL SFA. NO PARTS OF THE DEVICE REMAINED IN THE PATIENT, AND NO FURTHER INCIDENT WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9675745 ↗
• MalfunctionOct 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS USING SILVERHAWK ALONG WITH NON MEDTRONIC 6FR SHEATH AND GUIDE WIRE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT DISTAL TIBIAL/POPLITEAL TRUNK WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS WITH 4 MM DIAMETER. THE VESSEL WAS PRE DILATED BUT NOT POST DILATED. IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. IT WAS REPORTED THAT THE DEVICE TIP DETACHED DURING WITHDRAWAL. MODERATE RESISTANCE WAS FELT AND THE NOSECONE DETACHED. THE SILVERHAWK WAS USED TO SHAVE THE DISTAL POPITEAL AND PT TRUNK. AFTER SHAVING, THE DEVICE WAS INSIDE THE SHEATH COMING ACROSS THE EXTERNAL ILIAC AND THE NOSECONE SEPARATED AND REMAINED IN THE SHEATH AFTER THE CATHETER WAS REMOVED. THE NOSECONE REMAINED ON THE WIRE INSIDE THE SHEATH UNTIL THE SHEATH WAS REMOVED. A NON MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9166673 ↗
• InjurySep 9, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  PHYSICIAN USED A SILVERHAWK DEVICE DURING TREATMENT OF A 200 MM CALCIFIED LESION IN THE PATIENT¿S MID, DISTAL AND PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6 MM. MODERATE TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 30-40% STENOSIS. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. IT IS REPORTED THAT THE DEVICE WAS USED WITHOUT ISSUE TO TREAT AN INITIAL CTO AT MID/DISTAL LESION. FOUR PASSES WERE MADE WITH THE SILVERHAWK DEVICE. MINIMAL RESISTANCE WAS EXPERIENCED WHEN REMOVING THE DEVICE. MINIMAL GRIP APPLIED AND THE RESISTANCE WAS RELINQUISHED AS BREAK OCCURRED. ANGIOGRAM VISUALIZED A LOOP IN THE WIRE DISTAL TO SHEATH TIP AND CONFIRMATION OF DEVICE TIP REMAINING ON WIRE. A DILATOR ADVANCED THROUGH THE SHEATH IN AN ATTEMPT TO STRAIGHTEN WIRE UNSUCCESSFULLY, RESULTING IN THE WIRE BREAKING APART. THE DILATOR AND WIRE END WERE REMOVED. A NON-MEDTRONIC 0.014 GUIDEWIRE WAS ADVANCED TO THE ORIGINAL LESION, FOLLOWED BY SUCCESSFUL USE OF TWO NANOCROSS PTA BALLOONS AT 10ATM AND 8 ATM RESPECTIVELY. A GOOSENECK SNARE WAS THEN ADVANCED VIA RIGHT ANTEGRADE ACCESS WITH A 6FR SHEATH IN ATTEMPT TO SNARE THE BROKEN WIRE AND TIP. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MAD

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 8974734 ↗
• MalfunctionMay 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A SILVERHAWK BTK FOLLOWED BY A NANOCROSS PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID POSTERIOR TIBIAL ARTERY. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. IFU WAS FOLLOWED. THE ATHERECTOMY DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT DURING REMOVAL OF THE DEVICE, IT BECAME WRAPPED AND THE TIP SEPARATED BUT REMAINED ON THE WIRE. THE SILVERHAWK AND WAS REMOVED IN TANDEM WITH THE SHEATH. DUE TO REMOVAL OF THE SHEATH ACCESS WAS LOST AND THE PROCEDURE WAS COMPLETED AT THIS POINT. NO ALLEGATION AGAINST THE NANOCROSS DEVICE. DEVICE NOT USED IN PATIENT. NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8649013 ↗
• InjuryDec 10, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE AND A SILVERHAWK TO TREAT A SEVERELY CALCIFIED LESION WITH 75-90% STENOSIS IN THE RIGHT MID PROXIMAL TIBIAL POPLITEAL TRUNK. ARTERY DIAMETER AND LESION LENGTH WERE 3MM AND 40MM RESPECTIVELY. PHYSICIAN USED A COOK 6FR 90CM SHEATH AND A COOK HYDRO 014X300. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. VESSEL WAS PRE AND POST DILATED. THE H1-S WOULD NOT CROSS. THE VESSEL WAS PRE-DILATED WITH A NANO 2X80 DEVICE AT 8ATM FOR 1MINUTE. THE H1-S WAS ATTEMPTED AGAIN BUT IT WOULD NOT CROSS THE LESION. PRE-DILATED AGAIN WITH THE SAME NANO DEVICE AT 14 ATM FOR 1.5 MIN. PHYSICIAN THEN ATTEMPTED TO USE A SILVERHAWK. THIS DEVICE CROSSED THE PROXIMAL LESION UPON THIRD ADVANCEMENT, BUT DID NOT CROSS MID OR DISTAL LESION AND UPON REMOVAL SCRUB TECHNICIAN NOTICED AN IRREGULARITY IN THE CLEAR HOUSING TIP. THE TIP OF THE SILVERHAWK WAS REPORTED TO FEEL RIDGED AND LOOKED IRREGULAR TO THE TECHNICIAN. IT WAS REMOVED SAFELY AND INTACT <(>&<)> WITHOUT DIFFICULTY. THERE WAS NO DEFORMITY NOTED WITH THE CUTTER. PHYSICIAN THEN CHOSE TO USE A 0.9 LASER FORWARD PASS AT 45/45 AND REVERSE PASS AT 45/60 ANGIOGRAM BUT WAS STILL NOT ACCEPTABLE. THUS, THE PHYSICIAN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8145801 ↗