SilverHawkTM P4034Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684074084), received between Jun 9, 2017 and Dec 3, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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

• InjuryDec 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN USED A SILVERHAWK DEVICE TO TREAT A CTO (CHRONIC TOTAL OCCLUSION) IN A SEVERELY CALCIFIED AND TORTUOUS DISTAL COMMON ILIAC ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. IFU WAS FOLLOWED AND NO ISSUES WERE IDENTIFIED. IT WAS REPORTED THAT THE NOSECONE BROKE OFF FROM THE TIP OF THE DEVICE IN THE SUPERFICIAL FEMORAL ARTERY LEADING TO VESSEL OCCLUSION. PATIENT WAS SENT TO SURGERY TO REMOVE THE SILVERHAWK NOSECONE.

  Patient problems: Occlusion

  MAUDE report 8124222 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL POSTERIOR TIBIAL ARTERY (PTA). THE VESSEL HAD LITTLE TORTUOSITY AND 50% STENOSIS. THE DEVICE WAS PREPPED AS PER THE DEVICE WITH NO ISSUES IDENTIFIED. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THROUGH THE VASCULATURE. RESISTANCE WAS ENCOUNTERED REMOVING THE DEVICE. THE NOSECONE OF THE DEVICE DETACHED, DISTAL TO THE CUTTER BLADE, DURING REMOVAL FROM THE PATIENT. THE TIP SEPARATED FROM THE BODY OF THE DEVICE BUT THE WIRE WAS REMOVED WITH THE NOSE CONE ON IT. NO INTERVENTION WAS REQUIRED. THE TIP DID NOT SEPARATE AT THE HINGE PIN. THERE WERE NO PATIENT SYMPTOMS, COMPLICATIONS OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317207 ↗
• MalfunctionJul 12, 2017Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A SILVERHAWK DEVICE FOR THE TREATMENT OF A MODERATELY TORTUOUS MODERATELY CALCIFIED LESION IN MID TIBIAL/POPLITEAL TRUNK WHICH EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. DEVICE PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE IS REPORTED AS BEING: JAMMED/WILL NOT CLOSE. THIS ISSUE OCCURRED DURING THE FIRST PASS. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH BUT NOT ALL OF THE WAY. THE DEVICE STOPPED FUNCTIONING WHILE IN USE IN THE PATIENT. PHYSICIAN WAS USING A SILVERHAWK DIRECTIONAL ATHERECTOMY DEVICE FOR THE TREATMENT OF A MODERATELY TORTUOUS MODERATELY CALCIFIED LESION IN MID TIBIAL/POPLITEAL TRUNK WHICH EXHIBITED CTO (CHRONIC TOTAL OCCLUSION). DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. THE DEVICE IS REPORTED AS BEING: JAMMED/WILL NOT CLOSE. IT WAS REPORTED THAT THIS ISSUE OCCURRED DURING THE FIRST PASS. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH BUT NOT ALL THE WAY. THE DEVICE STOPPED FUNCTIONING WHILE IN USE IN THE PATIENT. DEVICE WOULD NOT CLOSE ALL THE WAY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THERE WERE NO PIECES OF THE CUTTER NOTICED TO BE MISSING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6709758 ↗
• MalfunctionJun 9, 2017Split; Split

  PHYSICIAN ATTEMPTED TO USE A SILVERHAWK ATHERECTOMY DEVICE WITH A 6FR 45 CM SHEATH AND 0.014 GUIDEWIRE FOR THE TREATMENT OF A 100-300MM MODERATELY TORTUOUS SEVERELY CALCIFIED LESION WHICH EXHIBITED 70-80% STENOSIS LOCATED IN THE LEFT PROXIMAL MID POPLITEAL ARTERY <(>&<)> ANTERIOR TIBIAL (AT) ARTERY OF DIAMETER 2-2.5MM. THE IFU WAS FOLLOWED AND THE VESSEL WAS PRE-DILATED. GUIDEWIRE WAS HYDRATED AT PREP. SEVERE RESISTANCE WAS FELT DURING INITIAL ADVANCEMENT. DEVICE WAS UNABLE TO CROSS LESION. DEVICE WAS ADVANCED OVER BIFURCATION. GUIDEWIRE LUMEN WAS TORN FROM DISTAL TIP. AT WAS PRE DILITATED WITH A 2.5X 200 PTA. A NEW CATHETER WAS ABLE TO ADVANCE POST DILATATION TO TREAT LESION AND COMPLETE THE PROCEDURE. NO DAMAGE WAS DONE TO THE VESSEL. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6628996 ↗

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