SilverHawkTM P4044Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00821684074107), received between Jun 29, 2017 and Jun 8, 2018 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  PHYSICIAN USED A SILVERHAWK DEVICE FOR TREATMENT OF A 90% STENOSED PLAQUE 40MM LESION IN THE PATIENTS PROXIMAL TIBIAL/POPLITEAL TRUNK. SLIGHT TORTUOSITY AND CALCIFICATION WERE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE PROCEDURE USED A 7FR NON-MDT SHEATH AND A 0.014" NON-MDT GUIDEWIRE. IT IS REPORTED THE WIRE BECAME WRAPPED AROUND THE DEVICE AND CAUSED THE WIRE TO BREAK IN HALF. THE DISTAL TIP OF THE DEVICE ALSO BROKE IN HALF. THIS WAS NOTICED WHEN WITHDRAWING THE DEVICE AFTER PERFORMING ATHERECTOMY. THE DISTAL TIP OF THE DEVICE WOULD NOT FIT THROUGH THE SHEATH. THE SHEATH, WIRE, AND DEVICE HAD TO BE REMOVED TOGETHER. NO COMPONENT EMBOLISATION OCCURRED. THE INCIDENT OCCURRED AFTER ATHERECTOMY HAD BEEN PERFORMED AND THE PHYSICIAN STOPPED THE PROCEDURE AFTER THE INCIDENT. THE PATIENT HAD A MINOR HEMATOMA RELATED TO REMOVING THE SHEATH WHILE STILL HEPARINIZED.

  Patient problems: Hematoma

  MAUDE report 7581546 ↗
• MalfunctionMay 22, 2018Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  THE PHYSICIAN INTENDED TO USE THE SILVERHAWK TO TREAT A 20MM PLAQUE LESION WITH LITTLE CALCIFICATION, AND 60% STENOSIS IN THE LEFT MID ANTERIOR TIBIAL ARTERY. THE ARTERY WAS REPORTED AS HAVING LITTLE TORTUOSITY AND A DIAMETER OF 3MM. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED A BREAK OCCURRED IN THE CATHETER DURING RETRACTION OF THE DEVICE INTO THE SHEATH, DUE TO INTERACTION WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A HAWKONE-S,. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532967 ↗
• InjuryApr 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A SILVERHAWK DIRECTIONAL ATHERECTOMY CATHETER DEVICE DURING TREATMENT OF A SLIGHTLY CALCIFIED LESION IN THE PROXIMAL POSTERIOR TIBIAL ARTERY. LESION STENOSIS UNKNOWN. VESSEL REPORTED AS BEING SLIGHTLY TORTUOUS. DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. BALLOON ANGIOPLASTY WAS PERFORMED. IT IS REPORTED THAT THE NOSECONE BECAME LODGED ON THE ON THE WIRE IN THE PATIENT AND AFTER PULLING ON THE DEVICE THE NOSECONE DETACHED AND REMAINED ON THE WIRE. A SNARE WAS USED TO RETRIEVE THE DEVICE. NO FURTHER TREATMENT WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7453440 ↗
• MalfunctionNov 23, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE ONE SILVERHAWK BTK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A MID-RIGHT POSTERIOR TIBIAL ARTERY LESION, EXHIBITING (B)(4) STENOSIS. THE LESION WAS NOT PREDILATED. THE IFU WAS FOLLOWED DURING PREP, PROCEDURE AND POST PROCEDURE. IT WAS REPORTED THAT RESISTANCE WAS NOT FELT, THE DISTAL TIP WAS DAMAGED AND DID NOT ALLOW THE CUTTER BLADE TO FULLY OPEN & CLOSE. THE CUTTER DETACHED FROM THE DRIVESHAFT WHILE PACKING DOWN IN THE NOSECONE. WHEN THE PHYSICIAN THEN ATTEMPTED TO ACTIVATE THE CUTTER, IT WOULD NOT COME BACK TO THE CUTTER WINDOW AND REMAINED IN THE NOSECONE. THE TIP DID NOT SEPARATE AT THE HINGE PIN. THE PHYSICIAN COMPLETED THE PROCEDURE USING A NEW DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7057129 ↗
• MalfunctionOct 13, 2017Mechanical Jam; Mechanical Jam

  THE PHYSICIAN WAS ATTEMPTING TO USE ONE SILVERHAWK DIRECTIONAL ATHETERCTOMY DEVICE TO TREAT A SLIGHTLY TORTUOUS AND MODERATELY CALCI FIED LESION LOCATED IN THE TIBIAL/POPLITEAL TRUNK. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU. IT WAS REPORTED THAT THE CUTTER WINDOW JAMMED DURING THE PROCEDURE AND THAT THE PHYSICIAN WAS UNABLE TO CLOSE THE WINDOW DURING CUTTING. THE PHYSICIAN WAS UNABLE TO RETURN THE CUTTER TO THE HOUSING BEFORE THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN REMOVED THE DEVICE AND USED A NEW DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950203 ↗
• InjurySep 15, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY. THE RIGHT TIBIAL PERONEAL TRUNK HAD A DISTAL 90% LUMINAL DIAMETER STENOSIS AND THE RIGHT ANTERIOR TIBIAL ARTERY HAD A 10MM HAZY BAND IN THE PROXIMAL PORTION WHICH THE PHYSICIAN DECIDED TO PERFORM A PRESSURE PULL BACK GRADIENT WHICH YIELDED A 44 MMHB PRESSURE GRADIENT. THE ARTERY WAS DESCRIBED AS HAVING MODERATE TORTUOSITY WITH A 3MM DIAMETER. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A NON-MEDTRONIC 6FR 45CM SHEATH AND A 0.014¿ NO-MEDTRONIC GUIDEWIRE WAS USED DURING THE PROCEDURE. THE GUIDEWIRE WAS HYDRATED DURING PREPARATION. NO RESISTANCE WAS FELT DURING ADVANCEMENT AND EXCESSIVE FORCE WAS NOT USED. THE PHYSICIAN STATED THE FIRST PASS FELT FINE BUT ON THE SECOND PASS THE TIP OF THE SILVERHAWK ON THE GUIDEWIRE FELT AS IF IT PROLAPSED. VERY DISTAL EMBOLIZATION OCCURRED WITH NO TREATMENT REQUIRED. THE DEVICE WAS INSPECTED AND THE CUSTOMER STATED IT APPEARED THE WIRE LUMEN OF THE DEVICE WAS TORN. A KINK WAS FOUND ON THE DEVICE AND THE CUSTOMER BELIEVE THE DAMAGE OCCURRED WHEN THE DEVICE WAS PUSHED FORWARD. THE

  Patient problems: Embolism

  MAUDE report 6871254 ↗
• InjuryJun 29, 2017Difficult to Remove; Component or Accessory Incompatibility; Detachment of Device or Device Component; Difficult to Remove; Component or Accessory Incompatibility; Detachment of Device or Device Component

  THE PHYSICIAN USED ONE SILVERHAWK TO TREAT A NON-TORTUOUS AND NON-CALCIFIED LESION. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. ON ATTEMPTING TO REMOVE THE DEVICE, THE NON-MDT GUIDEWIRE PROLAPSED BETWEEN THE NOSECONE AND THE SHEATH CAUSING THE DEVICE TO BECOME STUCK. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO REMOVE THE DEVICE, EVENTUALLY CAUSING THE DISTAL TIP OF THE DEVICE TO BREAK OFF. THE TIP MIGRATED DOWN THE PERONEAL OF THE PATIENT RESULTING IN AN OCCLUDED PERONEAL ARTERY. IT WAS REPORTED THAT NO ATTEMPTS WERE MADE TO REMOVE THE DETACHED TIP AND THAT THE DEVICE FRAGMENT WAS LEFT IN THE PATIENT. NO OTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Occlusion

  MAUDE report 6676769 ↗

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