HawkOneRecalls & reported problems across all models

We found 11 models of HawkOne by Covidien LP in the FDA's device registry (GUDID). Together they are named in 592 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Sep 22, 2026 — classified as 145 injuries, 447 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (276 reports).

2 FDA recall records name at least one of these models by its device identifier.

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

HawkOne recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 6, 2021Terminated

   Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

   Z-0451-2022 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

2. Dec 6, 2021Terminated

   Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

   Z-0450-2022 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

Most reported HawkOne problems

HawkOne models

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

• HawkOne™ H1-M

  Catheter, peripheral, atherectomy
  1 recall367 reports
• HawkOne™ H1-S

  Catheter, peripheral, atherectomy
  1 recall70 reports
• HawkOne™ H1-M

  Catheter, peripheral, atherectomy
  1 recall20 reports
• HawkOne™ H1-S

  Catheter, peripheral, atherectomy
  1 recall3 reports
• HawkOne™ H1-LX

  Catheter, peripheral, atherectomy
  48 reports
• HawkOne™ H1-LS

  Catheter, peripheral, atherectomy
  37 reports
• HawkOne H1-LS

  Catheter, peripheral, atherectomy
  21 reports
• HawkOne™ H1-M

  Catheter, peripheral, atherectomy
  14 reports
• HawkOne H1-LX

  Catheter, peripheral, atherectomy
  9 reports
• HawkOne™ H1-S

  Catheter, peripheral, atherectomy
  2 reports
• HawkOne™ H1-14550

  Catheter, peripheral, atherectomy
  1 report

Recent HawkOne adverse event reports

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

• MalfunctionSep 22, 2026Physical Resistance/Sticking

  It was reported that during atherectomy of a calcified, 100% stenosed target lesion in the proximal left posterior tibial artery with a vessel diameter of 5.0 mm, the HawkOne H1-M device thumb switch would not move to the off position after cutting, including after removal from the body. Embolic protection was used with a Spider 4.0 device, the vessel was pre-dilated with a Nanocross 3 x 120 device, and post-dilated with an In.Pact 5 x 250 device. The HawkOne H1-M device was safely removed from the patient. The procedure was completed using a new Hawkone LS device. The event delayed surgery by 10 minutes. No patient complications have been reported as a result of this event. Additional information: when the device was returned for evaluation the cutter was detached/broken from the driveshaft.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850904 ↗
• MalfunctionSep 18, 2026Difficult to Remove; Material Deformation

  It was reported that an H1-LS device was initially inserted into the patient without difficulty during treatment of calcified plaque lesions in the left superficial femoral and popliteal arteries at proximal, mid, and distal locations. Difficulty was reported when removing the device for cleaning. After cleaning, the device could not be loaded onto the Spider Filter wire because the wire would not enter the device nosecone. An issue involving the tip was reported; the tip did not detach, and the guidewire lumen was not torn or ripped. A 7FR x 45 Terumo Destination sheath and 7.0 Spider Filter embolic protection were used. The target vessel was post-dilated, with no pre-dilation performed. The device was safely removed from the patient, and the procedure was completed successfully using a new H1-LS device without difficulty. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817342 ↗
• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565018 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 75% STENOSIS, 150 MM LESION IN THE PROXIMAL RIGHT TIBIAL/POPLITEAL TRUNK, THE HAWKONE S CUTTER DRIVER WOULD NOT CLOSE AND SUBSEQUENTLY STOPPED FUNCTIONING WHILE IN USE IN THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE BODY WITH NO DIFFICULTY, AND A NEW H1-S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ADDITIONALLY, THE RAPIDCROSS BALLOON WAS FOUND TO HAVE A CRACKED HUB, INFLATION DIFFICULTIES, AND A LEAK AT THE HUB/LEUR DURING PREPARATION; THIS DEVICE WAS NOT USED IN THE PATIENT. A NEW RAPIDCROSS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION AND PROCEDURE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES, AND THERE WERE NO ISSUES WITH PACKAGING OR DEVICE REMOVAL FROM THE TRAY. EMBOLIC PROTECTION WAS USED WITH A SPIDER FILTER WIRE, AND A 7 FRENCH TERUMO DESTINATION SHEATH WAS UTILIZED. THE VESSEL WAS POST-DILATED USING THE RAPIDCROSS DEVICE. THE PATIENT REMAINED ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE CUTTER WAS DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444481 ↗
• MalfunctionJun 4, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING THE ATHERECTOMY H1-M HAWKONE M TO TREAT A LONG CHRONIC TOTAL OCCLUSION PLAQUE LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, THERE WAS DIFFICULTY REMOVING THE ATHERECTOMY DEVICE FROM A 6F SHEATH. DURING THE PROCEDURE (IN VIVO), THE TIP/NOSECONE DETACHED AND THE GUIDEWIRE LUMEN WAS REPORTED TORN OR RIPPED. UPON REMOVAL, THE PHYSICIAN OBSERVED THE NOSECONE HAD BROKEN OFF AND WAS RETAINED WITHIN THE SHEATH AT THE END OF THE SHEATH, AND THE ENTIRE SHEATH WAS REMOVED TO RETRIEVE THE DETACHED NOSECONE FROM THE BODY. EMBOLIC PROTECTION WAS USED. THE VESSEL WAS POST-DILATED WITH A BALLOON, AND THE PROCEDURE CONTINUED WITH BALLOON AND STENT PLACEMENT. A HEMATOMA WAS REPORTED AS HAVING FORMED AND WAS MAINTAINED. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392173 ↗
• InjuryMay 29, 2026Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT A PATIENT WITH A PREVIOUSLY IMPLANTED NON-MEDTRONIC COVERED STENT IN THE PROXIMAL-TO-MID RIGHT SUPERFICIAL FEMORAL ARTERY UNDERWENT AN ENDOVASCULAR PROCEDURE USING THE HAWKONE LS DIRECTIONAL ATHERECTOMY SYSTEM TO TREAT SIGNIFICANT IN-STENT RESTENOSIS NEAR THE OSTIUM OF THE STENT CLOSE TO THE PROFUNDA ORIGIN. THE LESION EXHIBITED APPROXIMATELY 90% STENOSIS WITH A 30MM LESION LENGTH AND MODERATE CALCIFICATION. DURING PROCEDURAL PLANNING, THE MEDTRONIC REP STATED THAT THE HAWKONE DEVICE IS NOT INDICATED FOR TREATMENT OF IN-STENT RESTENOSIS AND DISCUSSED THE RISK OF INTERACTION BETWEEN THE DEVICE BLADES AND STENT STRUTS. PHYSICIAN STATED HE HAD PREVIOUSLY USED DIRECTIONAL ATHERECTOMY IN IN-STENT RESTENOSIS (ISR) CASES AND WISHED TO PROCEED DUE TO THE SEVERITY OF THE LESION AND DESIRE FOR ADDITIONAL LUMINAL GAIN AND DEBULKING. THE MEDTRONIC REP ALSO STATED THAT THERE WAS NO EXPECTATION OR PRESSURE TO USE MEDTRONIC PRODUCTS DURING THE PROCEDURE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. LEFT FEMORAL ACCESS WAS OBTAINED AND ANGIOGRAPHIC IMAGING WAS PERFORMED. A 7X45 NON-MEDTRONIC SHEATH WAS USED, FOLLOWED BY A 035X150 TRAILBLAZER SUPPORT CATHETER, AND A 5MM SPI

  Patient problems: Perforation; Vascular Dissection

  MAUDE report 25329737 ↗
• MalfunctionMay 25, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT A HAWKONE M ATHERECTOMY DEVICE WAS USED DURING TREATMENT OF A FIBROUS LESION IN THE PATIENTS MID/DISTAL RIGHT POPLITEAL ARTERY. THE TARGET LESION WAS DESCRIBED AS 70% STENOSIS WITH A 120MM LENGTH IN A 5MM VESSEL AND MINIMAL TORTUOSITY. A 65CM 6FR NON-MEDTRONIC SHEATH AND A 300CM .014 NON-MEDTRONIC GUIDEWIRE WERE USED. THE DEVICE WAS ADVANCED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT WHILE IN USE THE CUTTER DRIVER THUMBSWITCH STOPPED FUNCTIONING AND A MECHANICAL JAM OCCURRED. THE CUTTER WAS REPORTED TO HAVE CRASHED WITH THE CUTTER POSITIONED OUTSIDE THE HOUSING, INCLUDING DURING DEVICE REMOVAL FROM THE PATIENT. THE THUMBSWITCH WAS ABLE TO BE TURNED OFF, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO DEFORMATION WAS NOTED TO THE CUTTER. THE VESSEL WAS POST-DILATED WITH A 5X150MM INPACT DRUG-COATED BALLOON, AND THE PROCEDURE WAS COMPLETED USING A NEW HAWKONE M ATHERECTOMY DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25269273 ↗
• MalfunctionMay 23, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE TO TREAT A PERIPHERAL ARTERIAL PLAQUE LESION IN THE RIGHT SUPERFICIAL FEMORAL A RTERY (PROXIMAL AND MID SEGMENTS), A HAWKONE M ATHERECTOMY DEVICE WAS USED WITH EMBOLIC PROTECTION AND THE VESSEL WAS POST-DILATED WITH AN INPACT 018 DRUG-COATED BALLOON. DURING THE PROCEDURE, THE CATHETER REPORTEDLY HAD DIFFICULTY LOCKING INTO THE CUTTER DRIVER, AND THE CUTTER DRIVER REPORTEDLY STOPPED FUNCTIONING WHILE THE DEVICE WAS IN USE IN THE PATIENT. DURING DEVICE REMOVAL, THE CUTTER POSITION WAS REPORTED TO BE OUTSIDE THE HOUSING. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW H1-M DEVICE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264572 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATHERECTOMY H1-M HAWKONE M WAS USED TO TREAT A PERIPHERAL ARTERY TARGET LESION IN THE LEFT MID POPLITEAL ARTERY THAT WAS CALCIFIED WITH SEVERE CALCIFICATION, 95% STENOSIS, 25 MM LESION LENGTH, AND 6 MM VESSEL DIAMETER, WITH MINIMAL TORTUOSITY. THE VESSEL WAS PRE-DILATED USING A 3X40X130 NANOCROSS, AND EMBOLIC PROTECTION WAS USED WITH A 7 MM SPIDERFX 320 MM. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND DEVICE TIP DAMAGE WAS NOTED. DURING THE PROCEDURE IN VIVO, THE DEVICE TIP DETACHED AT THE HINGE PIN, AND GUIDEWIRE PROLAPSE WAS REPORTED TO HAVE LED TO THE TIP DETACHMENT. THE DETACHED TIP WAS REMOVED WITHIN THE SHEATH, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. AFTER REMOVAL OF THE DEVICE AND SHEATH, WIRE POSITION WAS MAINTAINED, A NEW SHEATH WAS INSERTED, AND THE LESION WAS BALLOONED WITH A DRUG-COATED BALLOON TO COMPLETE THE PROCEDURE, WITH POST-DILATION PERFORMED USING ADM06006013P. THE PATIENT WAS REPORTED ALIVE WITH NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160509 ↗
• MalfunctionMay 5, 2026Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING THE ATHERECTOMY H1-M HAWKONE M IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND RIGHT POPLITEAL ARTERY (PROXIMAL, MID, AND DISTAL SEGMENTS), THE DEVICE WAS INSERTED AND USED SUCCESSFULLY FOR 5¿6 PASSES, AFTER WHICH THE THUMB SWITCH FELT RESTRAINED WHEN SWITCHING THE DEVICE OFF AND THE NOSE CONE GAUGE DID NOT APPEAR TO REGISTER/READ CORRECTLY. THE PHYSICIAN WAS ASKED TO REMOVE THE DEVICE, AND RESISTANCE WAS ENCOUNTERED AT THE SHEATH SUCH THAT THE PHYSICIAN INITIALLY COULD NOT REMOVE IT AND REQUIRED SEVERAL ATTEMPTS TO ADVANCE, TURN, AND RETRACT BEFORE IT WAS SUCCESSFULLY REMOVED. AFTER REMOVAL, THE NOSE CONE WAS VISIBLY BULGED, THE FLUSH TOOL WAS UNABLE TO BE REMOVED FROM THE NOSE CONE, AND SIGNIFICANT PLAQUE REMAINED VISIBLE IN THE FLUSH TOOL AFTER CLEANING AND FLUSHING. THE VESSEL WAS NOT ABLE TO BE COMPLETELY TREATED AND THE DEVICE COULD NOT BE REINSERTED TO CONTINUE USE DURING THE PROCEDURE. A 6F TERUMO PINNACLE SHEATH WAS USED. A IRONMAN 014 GUIDEWIRE WAS USED. THE TARGET LESION WAS DESCRIBED AS CALCIFIED AND SOFT TISSUE WITH MINIMAL TORTUOSITY AND MODERATE CALCIFICATION, AND THE VESSEL DIAMETER WAS REPORTED AS 6 M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086077 ↗
• MalfunctionApr 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATHERECTOMY H1-M HAWKONE M DEVICE WAS USED DURING TREATMENT OF A PERIPHERAL ARTERIAL LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY WITH CALCIFIED PLAQUE AND 80% STENOSIS, THE INNER PLUNGER BROKE DURING USE. THE TARGET VESSEL DIAMETER WAS REPORTED AS 6 MM, WITH MINIMAL TORTUOSITY AND MINIMAL CALCIFICATION. A 6FR ANSEL SHEATH AND A .014 RUNTHROUGH GUIDEWIRE WERE USED, EMBOLIC PROTECTION WAS NOT USED, THE VESSEL WAS NOT PRE-DILATED, POST-DILATION WAS PERFORMED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW H1-M DEVICE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO HEALTH CONSEQUENCES OR IMPACT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893863 ↗
• MalfunctionApr 14, 2026Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED THAT AN ATHERECTOMY PROCEDURE USING THE ATHERECTOMY HAWKONE S DEVICE WAS PERFORMED VIA PROXIMAL ACCESS TO THE RIGHT PROXIMAL ANTERIOR TIBIAL ARTERY TO TREAT A CALCIFIED LESION WITH MINIMAL TORTUOSITY, A LESION LENGTH OF 40MM, AND A VESSEL DIAMETER OF 3.5MM. A 70CM 6FR NON-MEDTRONIC SHEATH AND A 300CM .014 NON-MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS PRE-DILATED WITH A 3X80 NANOCROSS PTA BALLOON. THE HAWKONE S DEVICE WAS USED FOR 20 PLUS PASSES EASILY. PHYSICIAN STATED HE ONLY CUT IN 2 PLANES. RESISTANCE WAS REPORTED WHEN REMOVING THE DEVICE AT THE END OF THE PROCEDURE WHILE IT WAS INSIDE THE SHEATH, AND THE DEVICE WAS PULLED WITH A LITTLE FORCE. WIRE WRAP WAS REPORTED. DURING REMOVAL, THE DEVICE BROKE AT THE DISTAL END WITH TIP DETACHMENT OCCURRING, AND THE BROKEN FRAGMENT REMAINED WITHIN THE SHEATH. PHYSICIAN WAS ABLE TO SAFELY REMOVE WIRE AND SHEATH WITH BROKEN FRAGMENT INSIDE SHEATH. PHYSICIAN USED ANOTHER SHEATH TO TAKE POST-OP PICS TO ASSURE VESSEL WAS FREE OF FRAGMENT. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872385 ↗
• MalfunctionApr 10, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED PERIPHERAL ARTERY LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY USING THE HAWKONE DEVICE, THE THUMB SWITCH STOPPED WORKING AFTER TWO PASSES IN A HARD CALCIFIED LESION AND A MECHANICAL JAM WAS REPORTED. THE DEVICE WAS INITIALLY USED IN A SOFTER LESION IN THE COMMON FEMORAL ARTERY WITHOUT ISSUE. THE TARGET LESION WAS DESCRIBED AS MINIMALLY CALCIFIED WITH 60% STENOSIS, 40 MM LESION LENGTH, AND 6 MM VESSEL DIAMETER. EMBOLIC PROTECTION WAS USED WITH A SPIDERFX DEVICE, AND THE DEVICE WAS USED WITH A 7FR NON-MEDTRONIC SHEATH AND A 014 SPIDERFX WIRE. THE VESSEL WAS NOT PRE-DILATED AND WAS POST-DILATED USING A CHOCOLATE AND AN 018 DRUG COATED BALLOON. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO TURN OFF THE THUMB SWITCH, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO CUTTER DEFORMATION WAS NOTICED. DURING DEVICE REMOVAL, THE CUTTER POSITION WAS REPORTED AS OUTSIDE THE HOUSING, AND THE DEVICE WAS SAFELY REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW H1-LX DEVICE. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843806 ↗
• InjuryMar 30, 2026Entrapment of Device; Device Difficult to Setup or Prepare; Difficult to Remove; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN HAWKONE S WAS USED DURING A PERIPHERAL ARTERY PROCEDURE INVOLVING THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH A CALCIFIED, FIBROUS, PLAQUE, AND SOFT TISSUE TARGET LESION AND MODERATE TORTUOSITY. THE VESSEL WAS PRE-DILATED WITH A NANOCROSS 014 AND POST-DILATED WITH A COYOTE 2 MM 014, USING A TERUMO 6 FR SHEATH AND A COMMAND 014 300 CM GUIDEWIRE, AND EMBOLIC PROTECTION WAS NOT USED. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE DISTAL LESION COULD NOT BE CROSSED WHILE THE DEVICE WAS TURNED OFF. A GUIDEWIRE WRAP AROUND THE DEVICE WAS REPORTED DURING ATTEMPTED DEVICE REMOVAL, AND PHOTOS WERE SAID TO SHOW THE GUIDEWIRE HAD BEEN LOADED INCORRECTLY DURING SETUP, WHICH WAS NOT RECOGNIZED WHILE INSERTING THROUGH THE SHEATH. DEVICE AND WIRE REMOVAL WAS DIFFICULT AND REQUIRED TRANSFER TO THE OPERATING ROOM, WHERE A SMALL APPROXIMATELY 3-INCH SURGICAL CUT-DOWN INCISION WAS PERFORMED TO REMOVE THE DEVICE AND GUIDEWIRE. THE CASE WAS COMPLETED BY TREATING BELOW THE KNEE WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOONS AT THE ANTERIOR TIBIAL AND PATIENT SEGMENT ONLY. THE PATIENT WAS REPORTED TO BE STABLE, ALIVE, AND WITHOUT INJURY, AND THE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729263 ↗
• MalfunctionMar 24, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF A 100% STENOSIS DUE TO PLAQUE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (PROXIMAL AND MID SEGMENTS, LESION LENGTH 30CM, ARTERY DIAMETER 6MM, MINIMAL TORTUOSITY AND CALCIFICATION), THE ATHERECTOMY H1-M HAWKONE M EXPERIENCED A MECHANICAL JAM AND THE CUTTER DRIVER/THUMBSWITCH STOPPED FUNCTIONING WHILE IN USE IN THE PATIENT. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH. THE CUTTER WAS POSITIONED OUTSIDE THE HOUSING AT THE TIME OF THE ISSUE AND DURING DEVICE REMOVAL, WITH NO DEFORMATION NOTED IN THE CUTTER. THIS ISSUE IS REPORTED FOR 2 HAWKONE M ATHERECTOMY DEVICES. A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS PRE-DILATED WITH A 3X150 NANOCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. THE VESSEL WAS POST-DILATED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680117 ↗

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