HawkOne™ H1-M (UDI 00643169968332)Recalls & reported problems

Summary

The FDA's MAUDE database contains 367 adverse event reports that list this exact device (DI 00643169968332), received between Apr 3, 2018 and Sep 22, 2026 — classified as 96 injuries, 271 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (197 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K161361); 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.

Recalls naming this device

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-0450-2022 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 367 reports, 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 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565018 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 24, 2026Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE HAWKONE M DEVICE TO TREAT PERIPHERAL ARTERY DISEASE IN THE RIGHT MID-POPLITEAL ARTERY, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE THUMB SWITCH. THIS ISSUE CAUSED A DELAY IN SURGERY OF APPROXIMATELY 30 MINUTES. A DISTAL ANEURYSM WAS NOTED IN RELATION TO THE ANATOMY, AND A MEC RUPTURE OR ANEURYSM WAS REPORTED AS A PRODUCT ISSUE. THE PATIENT HAD AN APPROXIMATELY 80% STENOSIS PLAQUE, 150MM IN LENGTH AND 5MM IN DIAMETER, WITH MINIMAL TORTUOSITY AND CALCIFICATION. THE LESION WAS POST-DILATED WITH A DRUG-COATED BALLOON, AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED VIABAHN STENT. EMBOLIC PROTECTION WAS USED WITH A SPIDER DEVICE, AND A TERUMO DESTINATION SHEATH AND 6MM SPIDER WIRE WERE UTILIZED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW H1-M DEVICE. NO DEATHS, ILLNESSES, INFECTIONS, OR ADVERSE HEALTH CONSEQUENCES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674235 ↗
• 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 24673380 ↗
• MalfunctionMar 23, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE USING THE HAWKONE M DEVICE IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY WITH A FIBROUS LESION, A MECHANICAL JAM OCCURRED WHEN THE DEVICE WOULD NOT PACK AFTER THE FIRST PASS IN THE LESION AND THE THUMBSWITCH WOULD NOT FULLY ENGAGE FORWARD. THE UTTER WAS OUTSIDE THE HOSING DURING DEVICE REMOVAL FROM THE PATIENT. THE VESSEL WAS PRE-DILATEDWITH A 3MM X 150MM NANOCROSS, EMBOLIC PROTECTION WAS USED WITH A 4MM SPIDER, A SPIDER GUIDEWIRE WAS UTILIZED, AND A 6F COOK ANSEL SHEATH WAS EMPLOYED. THE DEVICE WAS SAFELY REMOVED AND CLEANED ACCORDING TO INSTRUCTIONS FOR USE, BUT THE ISSUE PERSISTED. ANOTHER H1-M DEVICE WAS OPENED AND USED WITHOUT INCIDENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659895 ↗
• MalfunctionMar 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF PLAQUE IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (6MM ARTERY DIAMETER) WITH THE ATHERECTOMY H1-M HAWKONE M DEVICE, THE DEVICE APPEARED FULL AFTER CUTTING ONE QUADRANT. THE CUTTER WAS OUTSIDE THE HOUSING DURING REMOVAL FROM THE PATIENT. THE THUMB SWITCH WOULD NOT PACK THE CUTTER OR MATERIAL INSIDE TO PROCEED, AND AFTER REMOVAL AND CLEANING PER INSTRUCTIONS FOR USE, THE CUTTER WINDOW WOULD NOT CLOSE. THE THUMB SWITCH WAS DESCRIBED AS JAMMED AND UNABLE TO RETURN TO POSITION, INDICATING A MECHANICAL JAM. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO ABNORMALITIES IN ANATOMY WERE NOTED. NO DEATH WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638627 ↗
• MalfunctionJan 23, 2026Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED WITH THE HAWKONE M DEVICE DURING TREATMENT OF A 100% CHRONIC TOTAL OCCLUSION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, WHICH EXHIBITED MODERATE CALCIFICATION AND FIBROUS TISSUE. THERE WAS NO ISSUES WITH WIRE WRAP, THE DEVICE INSTEAD HAD DIFFICULTY BEING REMOVED FROM THE PATIENT DUE TO AN ISSUE WITH THE NOSE CONE, THERE WAS A KINK IN THE NOSE CONE THAT MADE REMOVING THE HAWK DEVICE DIFFICULT. FURTHERMORE, THE KINK IN THE NOSE COME APPEARED TO RESULT IN PLAQUE EXPUNGING THROUGH THE SIDE. THE PROCEDURE INVOLVED USE OF A 6F SHEATH, SPIDERFX 6MM GUIDEWIRE AND EMBOLIC PROTECTION DEVICE, AND BOSTON SCIENTIFIC RANGER 6X200MM FOR POST-DILATION. THE VESSEL WAS PRE-DILATED AND POST-DILATED, AND MINIMAL TORTUOSITY WAS NOTED. THE DEVICE WAS PULLED WITH RESISTANCE BUT REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY OR INTERVENTION, AND NO VESSEL DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. A NEW HAWK ONE M DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161206 ↗
• MalfunctionJan 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE END OF THE CLEAN OUT DEVICE BLEW OFF DURING SALINE ASPIRATION WHILE FLUSHING FOR CLEANOUT OF PACKING STORAGE OF THE ATHERECTOMY H1-M HAWKONE M DEVICE. THE PATIENT WAS BEING TREATED FOR PLAQUE IN THE LEFT PROXIMAL, MID, DISTAL SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. ARTERY DIAMETER REPORTED AS 3-5 MM. A 6FR NON-MEDTRONIC (TERUMO DESTINATION) SHEATH AND A 5MM SPIDER FX EMBOLIC PROTECTION DEVICE WERE USED. THE VESSEL WAS PRE-DILATED WITH A 3X200 NON-MEDTRONIC (BOSTON SCIENTIFIC STERLING) BALLOON. THE VESSEL WAS POST-DILATED WITH AN IPU05015013P IN.PACT 018 DRUG COATED BALLOON. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW H1-M DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055737 ↗
• MalfunctionDec 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING USE OF THE ATHERECTOMY H1-M HAWKONE M, THE THUMB SWITCH WOULD NOT PUSH ALL THE WAY FORWARD TO CLOSE THE CUTTING MOUTH. THE DEVICE WAS CLEANED NORMALLY BUT THE EXPOSED BLADE PREVENTED DEVICE REMOVAL FROM THE CLEANING TOOL. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW HAWKONE M DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776466 ↗
• MalfunctionDec 2, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF A PLAQUE/SOFT TISSUE LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (PROXIMAL, MID, AND DISTAL SEGMENTS; 90% STENOSIS; 30CM LENGTH; 6MM DIAMETER) WITH THE HAWKONE M DEVICE, A BULGE WAS OBSERVED IN THE NOSECONE AFTER FOUR PASSES AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WAS ONLY HALF FULL AT THE TIME OF THE ISSUE. THE DEVICE WAS PULLED WITH RESISTANCE AND REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY OR INTERVENTION, AND THE TECOTHANE JACKET REMAINED INTACT. A 55CM 6F NON-MEDTRONIC SHEATH AND A 7MM SPIDER FX EMBOLIC PROTECTION DEVICE WERE USED. POST-DILATION WAS PERFORMED USING .035 INPACT 6X250 AND 6X80 DEVICES. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691506 ↗
• InjuryNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HAWKONE M ATHERECTOMY DEVICE¿S TIP BROKE OFF AND LODGED IN THE PATIENT'S ARTERY. A RETURN TO SURGERY OCCURRED AND THE BROKEN TIP WAS SUCCESSFULLY RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 23645074 ↗
• MalfunctionNov 20, 2025Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY USING THE HAWKONE M DEVICE, THE DEVICE BECAME STUCK IN A 6F NON-MEDTRONIC (DESTINATION) SHEATH AND COULD NOT BE REMOVED. SEVERE WIRE WRAP AND KINKS IN BOTH THE NON-MEDTRONIC (BOSTON SCI PLATINUM PLUS .014) WIRE AND CATHETER WERE OBSERVED, RESULTING IN THE SYSTEM BEING STUCK IN THE SHEATH. RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE SYSTEM FROM THE WIRE. AFTER REVIEWING IMAGES AND LIVE FLUOROSCOPY TO ASSESS DEVICE INTEGRITY AND POSITION, THE SYSTEM APPEARED INTACT WITH NO DETACHMENT AT THAT TIME. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO UN-WRAP THE SYSTEM. THE PHYSICIAN WAS DIRECTED TO REMOVE THE WIRE, SYSTEM, AND SHEATH TOGETHER, WHICH WAS PERFORMED SUCCESSFULLY WITHOUT VESSEL DAMAGE. AFTER REMOVAL FROM THE PATIENT, SEVERAL ATTEMPTS WERE MADE TO EXTRACT THE HAWK CATHETER FROM THE SHEATH, AND THE DEVICE WAS EVENTUALLY PULLED OUT WITH EXTREME FORCE, AT WHICH POINT NOSECONE DETACHMENT OCCURRED OUTSIDE THE PATIENT. NO EMBOLIC PROTECTION WAS USED, AND THE VESSEL WAS NOT PRE- OR POST-DILATED. THE PHYSICIAN HAD MADE FIVE PASSES WITH THE DEVICE OVER A .014 NON-MEDTRONIC (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606112 ↗
• MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TH HAWKONE M DEVICE EXPERIENCED DETACHMENT OF THE NOSECONE FROM THE CUTTER AND PACKER DURING CLEANING AFTER USE. THE PROCEDURE INVOLVED TREATMENT OF THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. EMBOLIC PROTECTION WAS USED WITH A SPIDER EPD DEVICE, AND POST-DILATION WAS PERFORMED WITH AN INPACT 018 DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT PRIOR TO THE DETACHMENT EVENT, AND THE DETACHED COMPONENT WAS REMOVED DURING CLEANING. THE PROCEDURE WAS COMPLETED AFTER CLEANING THE DEVICE WITH POST-DILATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520607 ↗
• MalfunctionOct 21, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING USE OF THE HAWKONE M DEVICE, REMOVAL DIFFICULTIES WERE ENCOUNTERED AS THE DEVICE WAS DIFFICULT TO REMOVE FROM THE SHEATH. UPON REMOVAL, DEBRIS APPEARED TO BE COMING OUT OF PORES IN THE NOSECONE. THE DEVICE WAS PULLED WITH RESISTANCE AND REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY OR INTERVENTION, AND THERE WAS NO VESSEL DAMAGE. NO TEARS WERE NOTICED TO THE TECOTHANE JACKET. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347858 ↗
• MalfunctionJul 22, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF PLAQUE IN THE LEFT SUPERFICIAL FEMORAL ARTERY USING THE HAWKONE M DEVICE, PLAQUE EXCISED FROM THE ARTERY WAS OBSERVED COMING OUT OF THE SIDES OF THE DEVICE (MEC HOLES) INSTEAD OF BEING PACKED WITHIN THE NOSECONE. THE PATIENT PRESENTED WITH PLAQUE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (PROXIMAL, MID, AND DISTAL SEGMENTS) WITH GREATER THAN 50% STENOSIS, MINIMAL TORTUOSITY, MINIMAL CALCIFICATION, AND A VESSEL DIAMETER OF 7 MM. THE PROCEDURE INVOLVED POST-DILATION AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. (THE PHYSICIAN STATED THAT THE DEVICE WAS WORKING HOW IT NORMALLY DOES, THAT IT TURNED OFF ONCE THE THUMBSWITCH WAS IN THE OFF POSITION, AND THAT THERE WAS NO RESISTANCE FELT ON THE THUMBSWITCH. REGARDING THE CUTTER ITSELF, HE STATED THAT HE DID NOT NOTICE ANY DEFORMATION IN THE CUTTER, BUT ALSO SAID THAT HE DIDN'T LOOK AT THE CUTTER. HE JUST WANTED A NEW DEVICE OPEN SO HE CAN CONTINUE TREATING THE PATIENT). THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW H1-M DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563244 ↗
• InjuryJul 4, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE HAWKONE M DEVICE TO TREAT A CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, A PATIENT PRESENTED WITH A SEVERELY CALCIFIED LESION CHARACTERIZED BY 80% STENOSIS, MINIMAL TORTUOSITY, A LENGTH OF 10 CM, AND AN ARTERY DIAMETER OF 5.5 MM. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. TIP DAMAGE AND A TORN GUIDEWIRE LUMEN WERE OBSERVED. THE NOSE CONE WAS SNARED OUT AS AN INTERVENTION, AND 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 22402624 ↗
• InjuryJun 23, 2025Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE USING THE HAWKONE M DEVICE IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, THERE WERE DELAYS IN SURGERY DUE TO PRODUCT MALFUNCTION, ADDING TWO HOURS TO THE CASE AND REQUIRING A SECOND ACCESS SITE. THE DEVICE TIP DETACHED IN VIVO DURING THE PROCEDURE, AND THE GUIDEWIRE LUMEN WAS TORN OR RIPPED. GUIDEWIRE PROLAPSE LED TO THE TIP DETACHMENT. THE DEVICE BECAME STUCK AT A LOCATION WHERE A STENT WAS PINCHED WITHIN A TORTUOUS GRAFT, AND MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING ADVANCEMENT, AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT IN AN AREA WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE ANATOMY WAS ABNORMAL, WITH THE PROCEDURE PERFORMED IN A GRAFT WITH A PINCHED STENT AT THE TOP. THE DETACHED TIP WAS SNARED AND REMOVED, AND THE PROCEDURE WAS COMPLETED WITH POST DRUG COATED BALLOON AND CLOSURE DEVICES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE HAWK DEVICE DID NOT ENTANGLE W ITH THE SPIDER DEVICE, ONCE THE PHYSICIAN TRIED REMOVING IT, AND PULLED UP INTO ILIAC AND THEN OVER BIFURCATION IT ENTANGLED BECAUSE IT GOT BEN

  Patient problems: Insufficient Information

  MAUDE report 22307386 ↗
• MalfunctionMay 9, 2025Detachment of Device or Device Component; Difficult to Advance; Positioning Problem; Detachment of Device or Device Component; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ATHERECTOMY H1-M HAWKONE M DEVICE, SEVERAL ISSUES WERE ENCOUNTERED. A 45CM 6FR NON-MEDTRONIC SHEATH WAS POSITIONED IN ORDER TO USE THE H1-M DEVICE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE DEVICE WAS ADVANCED OVER A 6MM SPIDER WIRE. THE DEVICE WOULD NOT PASS OVER THE BIFURCATION WITH MODERATE FORCE DUE TO THE PATIENT'S BILATERAL COMMON ILIAC 8X27 VISIPRO STENTS AND NARROW BIFURCATION, CONTRIBUTING TO MODERATE RESISTANCE. THE DEVICE WAS ROTATED IN THE SHEATH TO SEE IF THE JOG WOULD ALLEVIATE SOME TENSION. THE DEVICE WOULD STILL NOT ADVANCE AND THE TIP WAS SEEN ON X-RAY TO BE SEPARATING FROM THE CUTTER WITHIN THE SHEATH. THE DEVICE WAS SAFELY REMOVED FROM THE SHEATH IN ONE PIECE, WITH THE NOSECONE HANGING ON BY THE CUTTER. A H1-S WAS ALSO ATTEMPTED TO BE ADVANCED OVER THE BIFURCATION WITHOUT SUCCESS. THE TARGET LESION, SPECIFICALLY THE COMMON ILIAC ARTERIES ON BOTH THE RIGHT AND LEFT SIDES, WAS NOTED TO HAVE MODERATE TORTUOSITY AND CALCIFICATION. VESSEL DIAMETER REPORTED AS 8MM. THE PROCEDURE WAS COMPLETED USING POBA AND A DRUG COATED BALLOON INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161361. One submission often covers many models, so check the product and lot details in each record.

• Z-0451-2022 · Dec 6, 2021 · Terminated
  Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkO