SilverHawk™ P4044 (UDI 00643169968479)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169968479), received between Oct 23, 2018 and Jun 6, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  A SILVERHAWK ATHERECTOMY DEVICE WAS BEING USING FOR TREATMENT OF A 210MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION (CTO) IN THE MID/DISTAL REGION OF THE RIGHT ANTERIOR TIBIAL ARTERY. THE ARTERY DIAMETER WAS 2-3MM WITH MODERATE CALCIFICATION AND TORTUOSITY. THE DEVICE WAS INSPECTED AND PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE CATHETER DID NOT EXPERIENCE DIFFICULTY LOCKING INTO THE CUTTER DRIVER. IT WAS REPORTED THE DEVICE WOULD NOT PACK. ONCE THE CTO WAS CROSSED IT WAS PRE-TREATED WITH 2.0-2.5X 210 TAPEREDNANOCROSS PTA. EXL WAS LOADED ONTO 0.014 NON-MEDTRONIC WIRE AND ADVANCED INTO ANTERIOR TIBIAL ARTERY. SEVERAL PASSES WERE MADE, AND PHYSICIAN NOTICED HE HAD DIFFICULTY TURNING INTO OFF POSITION. THE CUTTER BLADE WOULD NOT GO INTO THE HOUSING POSITION WHEN THE THUMB SWITCH WAS PUSHED INTO THE OFF POSITION BOTH WHEN THE DEVICE WAS IN THE PATIENT AND OUTSIDE THE PATIENT. THE CUTTER WAS OUTSIDE THE HOUSING DURING THE REMOVAL FROM THE PATIENT. THE SCRUB TECH PUSHED THE THUMBSWITCH FORWARD AND KEPT IT FORWARD DURING THE REMOVAL. THE BATTERY PACK WAS TURNED INTO OFF POSITION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND CLEANED PER IFU. NO DAMAGE TO THE PATIENT¿S VE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069681 ↗
• MalfunctionMay 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN USED A SILVERHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A 20MM PLAQUE LESION IN THE PATIENT'S PROXIMAL LEFT TIBIAL/POPLITEAL TRUNK OF DIAMETER 2.5MM. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 75% STENOSIS. THE DEVICE WAS PREPPED AS PER IFU. IT IS REPORTED THE NOSECONE DETACHED FROM CATHETER, THE DRIVESHAFT WAS STILL IN PLACE. DETACHMENT OCCURRED WHILE IN THE PATIENT, LIKELY WHILE ENTERING THE SHEATH. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. THE DETACHED COMPONENT WAS REMOVED. THE NOSECONE DID NOT DETACH COMPLETELY, EVERYTHING WAS REMOVED IN TANDEM WITH NO ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO VESSEL DAMAGE. A NEW CATHETER WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14406333 ↗
• MalfunctionSep 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE SILVERHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID TO DISTAL POSTERIOR TIBIAL ARTERY (PTA) WITH 40-70% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 2-2.5MM AND 150MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUED NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. PACKAGING ISSUE OCCURRED. IT WAS REPORTED THAT AS PHYSICIAN WAS ATHERECTOMIES, THE THUMBSWITCH WOULD NOT GO INTO "OFF" POSITION. AS PHYSICIAN WAS USING THE ATHERECTOMY CATHETER, AFTER A FEW PASSES, THE SILVERHAWK WOULD NOT PACK/THUMBSWITCH WOULD NOT GO INTO "OFF" POSITION. THE DEVICE WAS REMOVED, FLUSHED AND CLEANED AS PER IFU BUT THE PROBLEM PERSISTENT WHEN IT WAS OUTSIDE OF THE PATIENT. PHYSICIAN TRIED RECONNECTING CATHETER TO CUTTER DRIVER, SUBMERGING NOSECONE IN SALINE AND TURNING IT ON, BUT THE PROBLEM PERSISTED. PHYSICIAN PUSHED THE THUMBSWITCH KEEPING FORT INTO OFF POSITION AND CUTTER DRIVER TURNED OFF, THE CUTTER WAS OUTSIDE THE HOUSING WHEN REMOVED FROM PATIENT. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THERE WAS NO INTERVENTION REQUIRED TO REMOVE DEVICE. A NEW CATHET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445384 ↗
• MalfunctionJul 29, 2021Difficult to Remove; Device Damaged by Another Device; Material Deformation; Positioning Problem; Difficult to Remove; Device Damaged by Another Device; Material Deformation; Positioning Problem

  PHYSICIAN ATTEMPTED TO USE A SILVERHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT POSTERIOR TIBIAL ARTERY. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. A MEDTRONIC NITREX GUIDEWIRE WAS USED. THE DEVICE WAS INSPECTED WITHOUT ISSUES NOTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PHYSICIAN NOTICED RESISTANCE WHEN TRYING TO REMOVE DEVICE FROM PATIENT. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DEVICE BECAUSE THE NOSE CONE DID NOT PASS THE CALCIFIED LESION. AS PHYSICIAN WAS TRYING TO REMOVE, IT WAS NOTICED THE WIRE LOOKED DISPLACED ANGIOGRAPHICALLY. WHEN THE DEVICE WAS TAKEN OUT IT WAS NOTICED THE GUIDEWIRE LUMEN IN THE NOSECONE CLOSEST TO THE CUTTER WINDOW WAS NOTED TO BE TORN. THE CUTTER WAS INSIDE THE HOUSING DURING DEVICE REMOVAL FROM PATIENT. NO DEFORMATION NOTED IN THE CUTTER. DAMAGE WAS NOTED TO THE TECOTHANE JACKET, WITH IT NOTED TO BE TORN. NO DETACHMENT OCCURRED. NO VESSEL DAMAGE NOTED. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO DAMAGE NOTED TO THE NITREX WIRE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245078 ↗
• MalfunctionJun 3, 2021Device Damaged by Another Device; Device Contamination with Chemical or Other Material; Device Damaged by Another Device; Device Contamination with Chemical or Other Material

  PHYSICIAN ATTEMPTED TO USE A SILVERHAWK BTK ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF AN 80MM SOFT TISSUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID RIGHT POPLITEAL ARTERY. SLIGHT VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 4MM. IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED. IT IS REPORTED THAT AFTER RUNNING THE DEVICE AND PULLED OUT OF THE BODY, A BLACK STRING LIKE SUBSTANCE WAS ENCOUNTERED COMING OUT OF THE CUTTER WINDOW. THE OBSERVED MATERIAL APPEARED TO BE FIBROUS. UNCLEAR IF THIS WAS PART OF THE DEVICE. THE DEVICE WAS NOT WIPED DOWN BETWEEN INSERTIONS. THE CUTTER WAS INSIDE HOUSING WHEN REMOVED. WHEN REMOVED FROM PATIENTS, ALL PARTS OF DEVICE WERE ACCOUNTED FOR. THE DEVICE WAS REMOVED SAFELY. A REPLACEMENT HAWK ONE DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929667 ↗
• MalfunctionOct 23, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A SILVER-HAWK ATHERECTOMY DEVICE DURING TREATMENT OF A 30MM SOFT TISSUE LESION IN THE PATIENT¿S PROXIMAL AND MID PERONEAL ARTERY. SLIGHT VESSEL TORTUOSITY IS REPORTED. LESION EXHIBITED 60% STENOSIS. ARTERY DIAMETER REPORTED AS 3MM. IFU WAS FOLLOWED, AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. A BREAK IS REPORTED. IT IS REPORTED THE NOSE-CONE SEPARATED. THE ISSUE OCCURRED INSIDE THE PATIENT. ALL COMPONENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT WITH NO INTERVENTION REQUIRED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITH THE CUTTER INSIDE THE HOUSING. THERE WAS NO VESSEL DAMAGE NOTED. THE PROCEDURE WAS COMPLETED ALREADY PRIOR TO THE SILVER-HAWK NOSE-CONE DETACHMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10725239 ↗
• MalfunctionAug 24, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN INTENDED TO USE A SILVERHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A 100MM PLAQUE LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. MODERATE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. THE DEVICE WAS INSPECTED. NO ISSUES WERE NOTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT POST ATHERECTOMY WHEN REMOVING HE DEVICE FROM THE PATIENT, THE PHYSICIAN FELT RESISTANCE. UNDER FLUOROSCOPY IT WAS OBSERVED THE WIRE WRAPPED AND PROLAPSED AROUND THE ATHERECTOMY DEVICE. THE PHYSICIAN COULD NOT UNWRAP THE WIRE AND DECIDED PULLED THE DEVICE RESULTING IN THE WIRE AND DEVICE COMING OUT IN PIECES. ALL COMPONENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO VESSEL INJURY AND NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10441406 ↗
• MalfunctionJul 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO THE A MODERATELY CALCIFIED PLAQUE LESION IN THE PROXIMAL POPLITEAL ARTERY, TIBIAL/ POPLITEAL TRUNK AND ANTERIOR TIBIAL ARTERY. THE VESSEL IS LITTLE TORTUOUS. THE DEVICE WAS INSPECTED PER IFU WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED. A BREAK OCCURRED. IT WAS REPORTED THAT PHYSICIAN REALIZED DEVICE WAS BROKEN AFTER LOADING OVER THE WIRE AND THROUGH THE SHEATH. IT WAS NOT BROKEN WHEN INITIALLY LOADING ONTO THE WIRE. DEVICE WAS WORKING FINE, DEVICE WAS REMOVED TO BE CLEANED, THEN ONCE CLEANED, LOADED IT BACK ON THE WIRE. ONCE INSIDE THE BODY, PHYSICIAN REALIZED UNDER X-RAY THAT THE DEVICE WAS DISCONNECTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288135 ↗
• MalfunctionApr 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A SILVERHAWK BTK ATHERECTOMY DEVICE DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S PROXIMAL AND MID PERONEAL ARTERY. NO VESSEL TORTUOSITY AND SLIGHT CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED DURING USE IN THE PATIENT, THE DEVICE BROKE. THE END OF THE NOSECONE NEAR THE CUTTER WINDOW IS REPORTED TO HAVE SEPARATED FROM THE END OF THE CATHETER BUT REMAINED ATTACHED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9967589 ↗
• MalfunctionApr 8, 2020Misfire; Defective Device; Misfire; Defective Device

  PHYSICIAN INTENDED TO USE A SILVERHAWK DEVICE WITH A 6FR SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID AND DISTAL POPLITEAL ARTERY AND ANTERIOR TIBIAL ARTERY. NO VESSEL TORTUOSITY OR CALCIFICATION REPORTED. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS NOT PERFORMED. IT IS REPORTED THE DEVICE DID NOT ENGAGE WITH THE PLAQUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. IT IS UNKNOWN ABOUT THE POSITION OF THE BLADE RELATIVE TO THE HOUSING DURING REMOVAL OF THE DEVICE. THERE WAS NO DEFORMATION NOTED IN THE CUTTER. THE DEVICE WAS REPLACED WITH ANOTHER ATHERECTOMY DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO VESSEL DAMAGE NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9937927 ↗
• MalfunctionMay 29, 2019Mechanical Problem; Mechanical Problem

  PHYSICIAN INTENDED TO USE A SILVERHAWK DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID ANTERIOR TIBIAL ARTERY. MODERATE CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 75% STENOSIS. IFU WAS FOLLOWED. PRE-DILATION NOT PERFORMED. IT IS REPORTED THE BLADE WOULD NOT ADVANCE BACK INTO THE HOUSING UNIT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8649025 ↗
• MalfunctionMay 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN USED A SILVERHAWK BTK DEVICE TO TREAT A FIBROUS MODERATELY CALCIFIED, MODERATELY TORTUOUS 80% LESION IN THE PATIENT¿S MID TIBIAL/POPLITEAL ARTERY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. MODERATE RESISTANCE WAS FELT DURING WITHDRAWAL. IT WAS REPORTED THAT THE TIP BECAME DAMAGED AND DETACHED. IT DID NOT SEPARATE AT THE HINGE PIN BUT BECAME ENTANGLED IN WIRE. BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631084 ↗
• MalfunctionFeb 20, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE THE SILVERHAWK BTK DEVICE TO TREAT A FIBROUS SLIGHTLY CALCIFIED 60% STENOTIC LESION IN THE MID TIBIAL/POPLITEAL TRUNK. SLIGHT CALCIFICATION AND MODERATE TORTUOSITY ARE REPORTED. THE DEVICE WAS PREPPED AS PER IFU. THE VESSEL WAS PRE-DILATED. THE NITREX 014 GUIDEWIRE WAS HYDRATED AT PREP. NO RESISTANCE WAS FELT WHEN ADVANCING THE DEVICE OVER THE BIFURCATION. THE GUIDEWIRE WAS REPORTED TO HAVE COME OUT THROUGH THE NOSE CONE RESULTING IN A PERFORATION IN THE NOSE CONE. THE GUIDEWIRE LUMEN REMAINED IN-TACT. NO DIFFICULTY ENCOUNTERED REMOVING THE DEVICE, ALL DEVICE COMPONENTS WERE REMOVED FROM THE PATIENT, THE LESION WAS TREATED WITH A NANOCROSS BALLOON SUCCESSFULLY. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353982 ↗
• MalfunctionFeb 15, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A SILVER HAWK BTK DEVICE TO TREAT THE RIGHT (MID-DISTAL) PERONEAL ARTERY THAT WAS CALCIFIED AND PLAQUED WITH NO TORTUOSITY AND 80-90% STENOSIS IN A PATIENT. ARTERY DIAMETER AND LENGTH WERE 2.5MM AND 350MM RESPECTIVELY. THERE WAS NO ABNORMALITY REPORTED IN RELATION TO THE ANATOMY. ONCE THE TREATMENT WAS COMPLETED, THE THUMBSWITCH WOULD NOT MOVE FORWARD INTO OFF POSITION. ONCE REMOVED FROM THE PATIENT, DEVICE WAS CLEANED PER IFU AND THE PROBLEM PERSISTED. PHYSICIAN WAS UNABLE TO TURN IT OFF AND THE MOTOR WAS RUNNING. A NEW CUTTER DRIVER WAS USED TO SOLVE THE PROBLEM, BUT THE THUMBSWITCH STILL WOULD NOT CLOSE. IT WAS REPORTED THAT IT WAS JAMMED/WILL NOT CLOSE. A BRAND NEW CATHETER WAS USED TO CONTINUE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8342948 ↗
• MalfunctionOct 23, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A SILVERHAWK DEVICE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. WHILE IN USE IN THE PATIENT, THE CUTTER IS REPORTED TO HAVE JAMMED. IT WAS NOT POSSIBLE TO GET THE SWITCH INTO A FULL OFF POSITION. THE CUTTER WAS REPORTED TO HAVE BEEN CAUGHT IN THE MIDDLE OF THE HOUSING, LEAVING SOME OF IT EXPOSED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND NO DEFORMATION WAS NOTICED ON THE CUTTER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7995395 ↗