SilverHawkTMRecalls & reported problems across all models

We found 7 models of SilverHawkTM by Covidien LP in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2017 and Apr 5, 2019 — classified as 9 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SilverHawkTM problems

SilverHawkTM models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SilverHawkTM P4044

  Catheter, peripheral, atherectomy
  7 reports
• SilverHawkTM P4052

  Catheter, peripheral, atherectomy
  7 reports
• SilverHawkTM P4030

  Catheter, peripheral, atherectomy
  6 reports
• SilverHawkTM P4034

  Catheter, peripheral, atherectomy
  4 reports
• SilverHawkTM P4055

  Catheter, peripheral, atherectomy
  4 reports
• SilverHawkTM P4056

  Catheter, peripheral, atherectomy
  2 reports
• SilverHawkTM P4028

  Catheter, peripheral, atherectomy
  1 report

Recent SilverHawkTM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2019Use of Device Problem; Use of Device Problem

  THE PHYSICIAN WAS USING A SILVERHAWK TO TREAT A CALCIFIED FIBROUS SOFT TISSUE LESION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER OF 6MM AND VESSEL WAS A LITTLE TORTUOUS. THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT IT WAS HARD TO CLOSE THE DEVICE AFTER INITIAL PASS AND THE DEVICE WOULD NOT ACTIVATE A SECOND TIME. THE CUTTER MOUTH WOULDN¿T OPEN AND THE THUMBSWITCH WOULD NOT ENGAGE. THERE WERE NO ISSUES SWITCHING THE MOTOR ON/OFF . NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS USED AFTER THE USE BY DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486116 ↗
• MalfunctionDec 7, 2018Mechanical Problem; Mechanical Problem

  THE PHYSICIAN USED A SILVERHAWK DEVICE TO TREAT A SOFT TISSUE LESION WITH LITTLE DEGREE OF CALCIFICATION AND 90% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL PRESENTED LITTLE TORTUOSITY. THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED WITH NO ISSUED IDENTIFIED. IFU WAS FOLLOWED. IT WAS REPORTED THAT AFTER ONE INSERTION AND EIGHT PASSES, THE THUMBSWITCH BECAME JAMMED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141042 ↗
• MalfunctionDec 4, 2018Mechanical Problem; Mechanical Problem

  THE PHYSICIAN INTENDED TO USE THE SILVERHAWK WITH A 7F NON-MEDTRONIC SHEATH AND A SPIDER FX 6MM, TO TREAT A 150MM SOFT TISSUE LESION WITH 80-90% STENOSIS IN THE SUPERFICIAL AND POPLITEAL ARTERY. ARTERY DIAMETER 5MM. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES NOTED. THE VESSEL WAS NOT PRE-DILATED AND NO RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THE TIP OF THE SILVERHAWK BECAME DAMAGED BUT DID NOT COMPLETELY DETACH. THIS OCCURRED WHERE THE SHAFT MEETS THE CUTTER. THE PHYSICIAN OPENED A SECOND SILVERHAWK DEVICE. IT WAS REPORTED THAT THE THUMB SWITCH WAS STICKING AND COULD NOT BE PUSHED ALL THE WAY FORWARD. IT IS UNKNOWN IF THE CUTTER RETURNED TO THE HOUSING FOR REMOVAL OF THE DEVICE, BUT IT WAS REMOVED SAFELY. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SECOND DEVICE. NO DEFORMATION WAS NOTED IN THE CUTTER WHEN REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8127926 ↗
• 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 ↗
• MalfunctionNov 23, 2018Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  THE PHYSICIAN INTENDED TO USE THE SILVERHAWK WITH A 7F NON-MEDTRONIC SHEATH AND A SPIDER FX 6MM, TO TREAT A SOFT TISSUE LESION WITH 80-90% STENOSIS IN THE LEFT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES. ARTERY DIAMETER 5MM, LESION LENGTH 150MM, DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES NOTED. THE VESSEL WAS NOT PRE-DILATED, NO RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THE TIP OF THE SILVERHAWK DETACHED; THE CUTTER HOUSING PARTED FROM THE SHAFT. THE PHYSICIAN OPENED A SECOND SILVERHAWK AND REPORTED THAT THE THUMB SWITCH WAS STICKING AND COULD NOT BE PUSHED ALL THE WAY FORWARD. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SECOND DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8099854 ↗
• MalfunctionNov 13, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE THE SILVERHAWK DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A SOFT TISSUE LESION, WITH LITTLE TORTUOSITY, NO CALCIFICATION AND 99% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY(SFA) AS PER IFU. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED AFTER TWO PASSES THE DEVICE JAMMED AND BECAME EXCESSIVELY DIFFICULT TO CLOSE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063633 ↗
• InjuryJul 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN ATTEMPTED TO USE A SILVERHAWK WITH A NON-MEDTRONIC SHEATH AND GUIDEWIRE AS PER THE IFU TO TREAT A PLAQUE LESION WITH LITTLE CALCIFICATION AND LITTLE TORTUOSITY WITH 75% STENOSIS IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER AND LENGTH WERE 6MM AND 100MM RESPECTIVELY. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THE TIP DETACHED DURING ADVANCEMENT. THE WIRE LUMEN COVERING BECAME DETACHED DURING ADVANCEMENT OF THE CATHETER OVER ILIAC BIFURCATION, MODERATE RESISTANCE WAS FELT. IT WAS ALSO REPORTED THAT DURING ADVANCEMENT OF THE CATHETER OVER THE ILIAC BIFURCATION RESISTANCE WAS FELT, MORE PRESSURE WAS APPLIED BUT APPARENTLY THE CATHETER BECAME STUCK AND CAUSED THE SHEATH TO PROLAPSE INTO THE AORTA. AS THE PHYSICIAN WAS TRYING TO REMOVE THE CATHETER FROM THE SHEATH THE WIRE LUMEN COVERING PORTION BECAME COMPLETELY DETACHED AND ENDED UP BEING DEPOSITED IN THE LEFT COMMON FEMORAL ARTERY AREA. THE LESION TREATED WAS THE DISTAL RIGHT SFA. THE PATIENT WAS REPORTED TO BE STABLE DURING THE PROCEDURE. AN ATTEMPT WAS MADE TO SNARE THE PIECE OF WIRE LUMEN COVERING, THAT BECAME LODGED IN T

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 7662327 ↗
• 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 ↗
• InjuryMay 3, 2018Device Operational Issue; Device Operational Issue

  THE PHYSICIAN USED A SILVERHAWK DEVICE FOR THE TREATMENT OF A MODERATELY CALCIFIED LESION EXHIBITING 95% STENOSIS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT REPORTED TO BE TORTUOUS. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. IT IS REPORTED AFTER COMPLETING 4 PASSES, THE THUMBSWITCH BECAME STUCK IN THE ON POSITION. THE CUTTER WAS OUTSIDE OF THE HOUSING WHEN IT CRASHED BUT WAS ABLE TO GET INSIDE THE HOUSING WHEN THE TECH HELD FORWARD PRESSURE ON THE THUMBSWITCH AFTER THE POWER WAS TURNED OFF TO REMOVE THE DEVICE SAFELY FORM THE PATIENT. NO DEFORMATION WAS NOTED TO THE DEVICE ON REMOVAL FROM THE PATIENT. FOLLOWING REMOVAL, THE THUMBSWITCH REMAINED IN THE ON POSITION AFTER CLEANING THE DEVICE PREVENTING THE PHYSICIAN FROM MAKING ANY MORE PASSES. NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING STENTING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7482413 ↗
• 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 ↗
• MalfunctionApr 20, 2018Material Deformation; Material Deformation

  PHYSICIAN USED A SILVERHAWK DEVICE DURING TREATMENT OF A 60MM MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID RIGHT POPLITEAL ARTERY OF DIAMETER 8MM. THE VESSEL WAS DESCRIBED AS HAVING LITTLE TORTUOSITY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED THAT DURING REMOVAL, THE WIRE PORT OF THE SILVERHAWK PEELED AWAY FROM THE CATHETER. THE WIRE WAS STUCK IN THE WIRE PORT AND THE CATHETER AND WIRE HAD TO BE REMOVED TOGETHER. NO PATIENT INJURY REPORTED. PATIENT HAS A HISTORY OF HYPERTENSION AND PERIPHERAL VASCULAR DISEASE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7446068 ↗
• MalfunctionApr 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY CATHETER TO TREAT A PLAQUE LESION WITH LITTLE CALCIFICATION IN THE PROXIMAL SFA-POPLITEAL ARTERY (80% STENOSIS). THE ARTERY WAS NON-TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS NOT PRE OR POST DILATED. DURING THE INITIAL ADVANCEMENT SEVERE RESISTANCE WAS ENCOUNTERED. THE BLADE OF THE DEVICE COULD NOT BE RELEASED. THE TIP OF THE DEVICE EMBOLISED AND WAS CAPTURED WITHIN THE SHEATH. A NEW SILVERHAWK WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395126 ↗
• MalfunctionMar 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN USED A SILVERHAWK DEVICE DURING TREATMENT OF A SLIGHTLY CALCIFIED PLAQUE LESION IN THE LEFT MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS DESCRIBED AS SLIGHTLY TORTUOUS. THE LESION EXHIBITED 90% STENOSIS. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. FOLLOWING REMOVAL OF THE DEVICE AND WITH THE THUMBSWITCH IN THE CLOSED/OFF POSITION AND THE CUTTER WAS INSIDE OF THE HOUSING. IT WAS REPORTED THAT THE NOSECONE OF THE DEVICE APPEARED TO HAVE DETACHED FROM THE SHAFT AND NOT THE GUIDEWIRE LUMEN BUT THERE IS ACTUAL SEPARATION OF THE NOSECONE AND SHAFT OF THE DEVICE. NO DEFORMATION WAS REPORTED IN THE CUTTER. THE LESION WAS TREATED WITH A 5X40 BALLOON AND 6X40 STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7365198 ↗
• InjuryMar 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING A SILVERHAWK WITH A NON-MDT 7 FR SHEATH AND NON-MDT 0.014 GUIDEWIRE FOR THE TREATMENT OF A SLIGHTLY CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) PLAQUE LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS PREPPED AS PER IFU. THE VESSEL WAS NOT PRE OR POST DILATED. THE VESSEL WAS REPORTED TO BE SLIGHTLY TORTUOUS. IT IS REPORTED THAT MODERATE RESISTANCE WAS EXPERIENCED DURING WITHDRAWAL. THE TIP SEPARATED AT THE HINGE PIN AND THE NOSECONE TWISTED OFF. THE PATIENT WENT FOR SURGERY TO REMOVE THE DETACHED PORTION WHICH HAD OCCLUDED THE VESSEL. THE PATIENT IS REPORTED TO BE FINE.

  Patient problems: Device Embedded In Tissue or Plaque; Occlusion

  MAUDE report 7333513 ↗

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