HawkOne™ H1-S (UDI 00643169968356)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00643169968356), received between Apr 25, 2018 and Jun 9, 2026 — classified as 24 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (42 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. How this data works · Data updated Oct 13, 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-0451-2022 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 11, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE USING THE ATHERECTOMY HAWKONE , REMOVAL DIFFICULTIES WERE ENCOUNTERED IN THE MID LEFT ANTERIOR TIBIAL ARTERY, WHICH WAS SEVERELY CALCIFIED WITH 95% STENOSIS AND MINIMAL TORTUOSITY. THE DEVICE WAS PULLED WITH RESISTANCE AND REMOVED SUCCESSFULLY IN TANDEM WITH THE WIRE, WITHOUT INJURY OR INTERVENTION. IT WAS NOTED THAT THE WIRE WRAP AND MARKER BAND WERE PARTIALLY DETACHED. THE VESSEL WAS PRE-DILATED WITH A 2.5MM CHOCOLATE DEVICE AND POST-DILATED WITH A 3MM BD ULTRAVERSE. A 6F TERUMO DESTINATION SHEATH AND A .014 GLIDEWIRE ADVANTAGE TERUMO GUIDEWIRE WERE USED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND THERE WAS NO VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574859 ↗
• MalfunctionJan 23, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE HAWKONE DEVICE, THE ENTIRE DEVICE CAME OFF THE WIRE INSIDE THE BODY. THE EVENT OCCURRED IN THE PERIPHERAL ARTERIES, SPECIFICALLY THE SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, AND ANTERIOR TIBIAL ARTERY. THE TARGET LESION WAS CHARACTERIZED AS CALCIFIED, FIBROUS, PLAQUE, AND SOFT TISSUE WITH A MODERATE DEGREE OF CALCIFICATION AND MINIMAL TORTUOSITY, MEASURING APPROXIMATELY 40 MILLIMETERS IN LENGTH. UNDER ANGIOGRAPHY, THE WIRE APPEARED LOOPED IN A U SHAPE, AND IT WAS NOTED THAT THE WIRE WAS DAMAGED. THE DEVICE WAS REMOVED WITH RESISTANCE BUT WAS SUCCESSFULLY EXTRACTED IN TANDEM WITHOUT INJURY OR INTERVENTION. THE PROCEDURE WAS COMPLETED WITH POST-DILATION USING A NANOCROSS DEVICE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223503 ↗
• MalfunctionDec 10, 2024Difficult to Remove; Difficult to Advance; Positioning Problem; Difficult to Remove; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ATHERECTOMY HAWKONE S DEVICE, THERE WERE SEVERAL ISSUES ENCOUNTERED. THE PROCEDURE WAS DELAYED BY 15 MINUTES DUE TO A PRODUCT MALFUNCTION. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THERE WERE DIFFICULTIES IN REMOVING THE DEVICE. ADDITIONALLY, THE DEVICE WAS UNABLE TO CROSS THE LESION LOCATED IN THE PROXIMAL ANTERIOR TIBIAL ARTERY, WHICH WAS IDENTIFIED AS CALCIFIED. THE ARTERY DIAMETER WAS NOTED TO BE 2.8MM. THE VESSEL HAD BEEN PRE-DILATED USING A NANOCROSS DEVICE, BUT THE VESSEL WAS NOT POST-DILATED. DESPITE THE RESISTANCE, EXCESSIVE FORCE WAS NOT USED, AND THE DEVICE WAS EVENTUALLY REMOVED SUCCESSFULLY WITHOUT CAUSING VESSEL DAMAGE OR REQUIRING ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WHICH WAS NOT A MEDTRONIC PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891138 ↗
• MalfunctionNov 11, 2024Difficult to Remove; Difficult to Remove

  A PHYSICIAN WAS USING A HAWKONE ATHERECTOMY DEVICE FOR TREATMENT OF A 250MM PLAQUE LESION WITH 80% STENOSIS IN THE RIGHT ANTERIOR TIBIAL ARTERY. THE ARTERY WAS 3-4MM IN DIAMETER WITH MINIMAL CALCIFICATION AND TORTUOSITY. A 6FR NON MEDTRONIC SHEATH AND A SPIDER GUIDEWIRE. SPIDER WAS USED FOR EMBOLIC PROTECTION. THE VESSEL WAS NOT PRE-DILATED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE IFU WAS FOLLOWED. IT WAS REPORTED THERE WERE DIFFICULTY WITH REMOVAL OF THE DEVICE, THE PHYSICIAN PULLED WITH RESISTANCE, REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY/INTERVENTION. THE PROCEDURE WAS COMPLETED USING PTA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650866 ↗
• MalfunctionApr 8, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  A PHYSICIAN WAS USING A HAWKONE ATHERECTOMY DEVICE FOR TREATMENT OF A 100MM FIBROUS, PLAQUE, SOFT TISSUE LESION WITH 70% STENOSIS IN THE LEFT POSTERIOR TIBIAL ARTERY. THE ARTERY WAS 2.5-3MM IN DIAMETER WITH MILD TORTUOSITY AND CALCIFICATION. A NON MEDTRONIC SHEATH AND GUIDEWIRE WERE USED. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT MODERATE RESISTANCE WAS FELT DURING WITHDRAWAL AND THERE WAS PLAQUE BULGE THROUGH NOSECONE, THE TECOTHANE JACKET WAS INTACT. THE NOSECONE HAS A MALFORMATION OF THE JACKET WHERE THE PLAQUE HAS CAUSED A BULGE. THE PROCEDURE WAS COMPLETED USING PTA. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE TECOTHANE JACKET WAS BREACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058273 ↗
• InjuryFeb 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A HAWKONE TO TREAT A CALCIFIED LESION IN THE LEFT DISTAL ANTERIOR TIBIAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS MODERATE. LESION STENOSIS WAS 90%. A 6FR SHEATH WAS USED. A 014 GUIDEWIRE WAS USED. THE VESSEL WAS PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. IFU WAS FOLLOWED. MODERATE RESISTANCE WAS FELT. TIP DETACHED DURING WITHDRAWAL. TIP DID NOT SEPARATE AT HINGE PIN. TIP DETACHED APPROXIMATELY 2MM PROXIMAL TO NOSE CONE. SNARE WAS USED TO RETRIEVE TIP. WIRE/SNARE WAS RETRACTED. PRESSURE WAS HELD. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18623763 ↗
• InjuryAug 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A HAWKONE FOR TREATMENT OF A PLAQUE LESION WITH CHRONIC TOTAL OCCLUSION IN THE DISTAL REGION OF THE LEFT POPLITEAL ARTERY. THERE WAS MODERATE TORTUOSITY AND CALCIFICATION. A 6FR NON MEDTRONIC SHEATH AND A 0.014" NON MEDTRONIC GUIDEWIRE WERE USED. THE IFU WAS FOLLOWED. IT WAS REPORTED MODERATE RESISTANCE WAS MET DURING ADVANCEMENT AND THE TIP DETACHED AT THE HINGE PIN. THE TIP WAS SNARED OUT AND THE PROCEDURE WAS ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 17660716 ↗
• MalfunctionJun 20, 2023Entrapment of Device; Material Deformation; Physical Resistance/Sticking; Entrapment of Device; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A HAWKONE TO TREAT A CALCIFIED LESION IN THE LEFT MID ANTERIOR TIBIAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS MODERATE. STENOSIS WAS 90%. A 6 FR ANSEL SHEATH WAS USED. A .014 THRUWAY GUIDEWIRE WAS USED. VESSEL WAS NOT PRE-DILATED. VESSEL WAS NOT POST-DILATED. IFU WAS FOLLOWED. DEVICE WAS ADVANCED OVER BIFURCATION. GUIDEWIRE WAS HYDRATED AT PREPARATION. SEVERE RESISTANCE WAS FELT DURING WITHDRAWAL. AS A RESULT THERE WAS TIP DAMAGE. THE GUIDEWIRE LOCKED UP ON THE CATHETER. IT WAS REPORTED THAT DEVICE WAS ADVANCED INTO AT. 1 PASS WAS MADE TO THE LEVEL OF THE ANKLE. UPON REMOVAL OF THE DEVICE, RESISTANCE WAS ENCOUNTERED. SEVERAL ATTEMPTS WERE MADE TO REMEDY THIS. DECISION WAS MADE TO REMOVE SHEATH AND DEVICE. DEVICE WAS REMOVED IN TANDEM (TOGETHER). DEVICE WAS REMOVED AND PROCEDURE ENDED. THERE WAS NO VESSEL DAMAGE NOTED AND NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164489 ↗
• InjuryMay 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A HAWKONE TO TREAT A PLAQUE LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS MODERATE. A 7F NON-MEDTRONIC SHEATH WAS USED. A NON-MEDTRONIC GUIDEWIRE WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. IFU WAS FOLLOWED. IT IS REPORTED THAT THE TIP SEPARATED AT HINGE PIN. THE PHYSICIAN WAS COMPLETING FINAL PASS OF HAWONE AND WITHDRAWING FROM THE BODY. MODERATE RESISTANCE WAS FELT DURING WITHDRAWAL AND THE PHYSICIAN STATED THEY "PULLED A LITTLE HARDER THEN THEY WOULD LIKE 'AND THE NOSECOSE DETACHED NEAR THE SHEATH. A NON-MEDTRONIC SNARE WAS USED TO SNARE THE TIP INTO THE SHEATH AND REMOVE WHOLE DEVICE FROM BODY. THE PHYSICIAN TOOK AN ANGIO TO MAKE SURE NO VESSEL DAMAGE AND STATED THEY DID NOT SEE ANY VESSEL DAMAGE SO CONTINUED, FINISHING THE CASE WITH INPACT ADMIRAL IN SFA. PATIENT OUTCOME WAS SUCCESSFUL PER PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982278 ↗
• InjuryMar 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A HAWKONE ATHERECTOMY DEVICE WAS USED FOR TREATMENT OF A 200MM PLAQUE LESION WITH 50% STENOSIS IN THE LEFT SUPERFICIAL FEMORAL AND ARTERY POSTERIOR TIBIAL ARTERY. THE ARTERY DIAMETERS WERE 3.5-4MM. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE IFU WAS FOLLOWED. A 6FR NON MEDTRONIC SHEATH AND A 3MM SPIDER WERE USED. THE VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED THE TISSUE WAS DIFFICULT TO FLUSH AND IT WAS HARD TO PACK. AFTER REMOVING DEVICE IT WAS NOTED THAT THE TIP HAD DETACHED AT THE HINGE PIN. VESSEL WAS POST DILATED. THE PHYSICIAN SNARED THE TIP AND COMPLETED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 16564206 ↗
• MalfunctionMar 17, 2023Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN ATTEMPTED TO USE A HAWKONE S ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF THE PATIENT¿S PROXIMAL PERONEAL ARTERY. IFU WAS FOLLOWED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER IS REPORTED AS 2-3MM. SLIGHT VESSEL TORTUOSITY AND SLIGHT VESSEL CALCIFICATION ARE REPORTED. THE VESSEL WAS POST DILATED. TIP DETACHMENT IS REPORTED. WIRE WRAP WAS EXPERIENCED. THE PIN DID NOT SEPARATE AT THE HINGE. OPERATOR TECHNIQUE IS TO CONTROL BOTH THE HANDLE, ON AND OFF SWITCH, AND CATHETER IN AN EFFORT TO MAINTAIN CUTTING PLAIN ON THE ARTERY. RESISTANCE WAS FELT WHEN RETRACTING THE DEVICE. THE TIP WAS REMOVED/RETRACTED THROUGH THE SHEATH WITH FORCE. NO PATIENT INJURY REPORTED. PTA WAS PERFORMED TO COMPLETE THE PROCEDURE WITH GOOD RESULTS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564189 ↗
• MalfunctionJan 4, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A HAWKONE ATHERECTOMY DEVICE FOR THE TREATMENT OF A 300MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID/DISTAL SUPERFICIAL FEMORAL ARTERY POPLITEAL ARTERY. THERE WAS MILD TORTUOSITY AND SEVERE CALCIFICATION. A 6FR NON-MEDTRONIC SHEATH AND A 0.014" NON MEDTRONIC GUIDEWIRE WERE USED. THE IFU WAS FOLLOWED. THE VESSEL WAS PRE AND POST DILATED. IT WAS REPORTED THAT TIP DETACHMENT OCCURRED DURING WITHDRAWAL. IT DID NOT DETACH AT THE HINGE PIN. THE DEVICE WAS DIFFICULT TO BE REMOVED FROM THE PATIENT, SEVERE RESISTANCE WAS FELT, AND THE GUIDEWIRE LINE WAS PULLED AWAY FROM THE DEVICE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093728 ↗
• MalfunctionNov 27, 2022Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  A PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE-S FOR THE TREATMENT OF A CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE PROXIMAL/MID RIGHT ANTERIOR TIBIAL ARTERY. THERE WAS MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT SEVERE RESISTANCE WAS FELT DURING THE INITIAL ADVANCEMENT AND THE DEVICE WAS UNABLE TO CROSS THE LESION. A NANOCROSS WAS ABLE TO CROSS THE LESION. DURING WITHDRAWAL OF THE HAWKONE RESISTANCE WAS MET AGAIN AND THE NOSECONE DETACHED WHERE MEC MEETS THE BLACK CATHETER. 0.014" GUIDEWIRE WAS FUSED TO THE NOSECONE. ACCESS WAS LOST. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867188 ↗
• InjuryNov 1, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A HAWKONE WAS USED FOR TREATMENT OF A PLAQUE LESION WITH 90% STENOSIS IN THE PROXIMAL/MID REGION OF THE SUPERFICIAL FEMORAL ARTERY. THERE WAS SEVERE TORTUOSITY AND MILD CALCIFICATION. THE IFU WAS FOLLOWED. BRACHIAL ACCESS USED WITH A 90CM COOK ANSEL SHEATH OVER ABOSTON SCIENTIFIC CHOICE PT GUIDEWIRE. AFTER MULTIPLE PASSES AND TRYING TO WITHDRAW THE DEVICE IT WAS UNABLE TO GO BACK INTO THE SHEATH. MINIMAL FORCE WAS USED AND THE TIP DETACHED AT THE HINGE PIN. AFTER MAGNIFICATION IT WAS OBSERVED THAT THE GUIDEWIRE HAD PROLAPSED. AFTER TRYING UNSUCCESSFULLY TO REMOVE ENDOVASCULARLY, THE PATIENT WAS TAKEN TO THE OR AND A FEMORAL CUT DOWN WAS PERFORMED AND SUCCESSFULLY REMOVED EVERYTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709183 ↗
• InjuryAug 15, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY  ALONG WITH A NON-MEDTRONIC 6FR 45CM SHEATH, A 0.014" SPIDER GUIDEWIRE AND 3MM EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT PROXIMAL TO MID PERONEAL ARTERY WITH 80-90% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH WERE 3MM AND 20MM RESPECTIVELY. THE VESSEL WAS PRE DILATED BUT NOT POST DILATED. IFU WAS FOLLOWED. MODERATE RESISTANCE WAS FELT DURING ADVANCEMENT OF DEVICE AND THE TIP DETACHED CAUSING EMBOLIZATION. IT WAS REPORTED THAT WHILE RETRIEVING THE DEVICE AFTER TREATMENT THE SHEATH PROLAPSED INTO THE AORTA CAUSING WIRE WRAP. AS THE PHYSICIAN PULLED THROUGH SHEATH WIRE WAS WRAPPED AND PROLAPSED AROUND DEVICE AND TIP BECAME SEPARATED. FEMORAL CUTDOWN AND 14FR SHEATH WAS INSERTED. TIP AND SPIDER BASKET WERE PULLED OUT WITH 6FR SHEATH. ALL WAS PULLED BACK BY USING A SNARE/RETRIEVAL DEVICE TO TREAT COMPONENT EMBOLIZATION. ENDOVASCULAR PROCEDURE HAD TO CONVERT TO FEMORAL CUTDOWN TO RETRIEVE NOSECONE. PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT WAS HAWKONE DETACHED OFF OF DEVICE BY SHEATH. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15224223 ↗
• MalfunctionApr 13, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK PLUS DIRECTIONAL ATHERECTOMY DURING PROCEDURE ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED SOFT TISSUE LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY (POP) WITH 60% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 40MM RESPECTIVELY. THE VESSEL WAS NOT PRE DILATED BUT POST DILATED. IFU WAS FOLLOWED. TIP DETACHMENT/DAMAGE OCCURRED WITH A MODERATE RESISTANCE FELT DURING ADVANCEMENT. THE TIP DID NOT SEPARATE AT THE HINGE PIN. IT WAS REPORTED THAT AFTER THE FIRST PASS/CUT WAS MADE WITH THE TURBOHAWK, WHEN TECH PULLED THUMB SWITCH BACK TO TURN OFF DEVICE, IT DID NOT WANT TO COMPLETELY SHUT OFF. THEREFORE, THE TECH PROCEEDED TO TURN OFF THE BATTERY PACK AND THE DEVICE WAS REMOVED. THE PHYSICIAN DID NOT WANT TO WASTE TIME AND ASKED FOR THE DEVICE TO BE PUT IN A BIOHAZARD BAG. A HAWKONE WAS THEN ATTEMPTED TO CONTINUE PROCEDURE, AND IT WAS REPORTED THAT WHEN ADVANCING THE HAWKONE-S, PHYSICIAN FELT A LOT OF RESISTANCE, AFTER GETTING IT THROUGH THE SHEATH, THE DEVICE PERFORMED WELL. WHEN REMOVING THE DEVICE, PHYSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14099279 ↗
• InjuryNov 16, 2021Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH A NON-MEDTRONIC 6FR SHEATH AND 3MM SPIDER FX GUIDEWIRE AND EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT MID ANTERIOR TIBIAL ARTERY (ATA) WITH 95% STENOSIS. THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 3.5MM AND 5MM RESPECTIVELY. THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. TIP DETACHED AND SEPARATED AT THE HINGE PIN. THERE WAS NO RESISTANCE FELT. THE GUIDEWIRE PROLAPSE NEITHER CAUSED TIP DAMAGE OR EMBOLIZATION DURING PROCEDURE. THE TIP COMPLETELY DETACHED FROM THE DEVICE. IT WAS REPORTED THAT THE HAWKONE-S DEVICE WOULD NOT CROSS THE LESION. THE CATHETER WAS THEN PULLED BACK BY THE PHYSICIAN TO REMOVE THE DEVICE AND THE TIP DETACHMENT OCCURRED. NO RESISTANCE WAS FELT BY THE PHYSICIAN. THE TIP WAS SNARED WITH A GOOSENECK SNARE AND SUCCESSFULLY REMOVED. THE LESION, WAS THEN TREATED WITH A 3.0X40 CHOCOLATE ANGIOPLASTY TO COMPLETE THE PROCEDURE. THERE WAS NO VESSEL DAMAGE DUE TO THIS EVENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12819866 ↗
• MalfunctionOct 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH NON -MEDTRONIC 6FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE. THE VESSEL WAS NOT PRE DILATED BUT POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT DURING WITHDRAWAL, MINIMAL RESISTANCE WAS FELT AND THE TIP DETACHED WITH SEPARATION AT THE HINGE PIN. THE GUIDEWIRE PROLAPSE NEITHER CAUSED TIP DAMAGE NOR EMBOLIZATION DURING PROCEDURE. THE NOSE CONE DETACHED FROM THE CATHETER INSIDE OF THE CLEANING TOOL AFTER THE DEVICE WAS CLEANED. THE PHYSICIAN WANTED TO USE THE DEVICE AGAIN BUT WAS UNABLE TO DUE TO THE DAMAGE THAT OCCURRED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH BALLOON ANGIOPLASTY. THE EVENT HAPPENED OUTSIDE OF THE BODY ON THE BACK TABLE DURING THE CLEANING OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566922 ↗
• MalfunctionAug 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH NON-MEDTRONIC 90CM 6FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED FIBROUS, PLAQUE LESION IN THE RIGHT DISTAL POSTERIOR TIBIAL ARTERY (PTA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). NO EMBOLIC PROTECTION WAS USED. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 3-4MM AND 200MM RESPECTIVELY. THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. TIP DETACHED OCCURRED WITH NO RESISTANCE FELT. IT WAS REPORTED THAT AFTER ONE SUCCESSFUL PASS DOWN THE PTA, THE CATHETER WAS SLIGHTLY ROTATED AND THE DEVICE WAS RETRACTED PROXIMALLY TO PREPARE FOR A SECOND PASS WHEN IT WAS NOTED THAT THE WIRE HAD RETRACTED WITH THE DEVICE ALL THE WAY UP INTO THE SHEATH. THE DEVICE WAS REMOVED FROM THE SHEATH AND IT WAS MISSING THE ENTIRE NOSECONE . THE NOSECONE WAS LOCATED IN THE DISTAL END OF THE SHEATH. AF TER UTILIZING SYRINGE SUCTION THE NOSECONE LODGED INTO THE PROXIMAL SECTION OF THE SHEATH WHERE IT WAS ISOLATED AND THE SHEATH WAS CUT AWAY TO PRESERVE THE NOSECONE. NOTHING REMAINED AT THIS POINT IN THE PATIENT. PROCEDURE WAS COMPLETED BY INTRODUCING NEW SHEATH AND WIRE, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346828 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE ATHERECTOMY DEVICE FOR TREATMENT OF A LITTLE CALCIFIED, LITTLE TORTUOUS, PLAQUE LESION PRESENTING WITH CHRONIC TOTAL OCCLUSION IN THE MID SUPERFICIAL FEMORAL ARTERY. ARTERY DIAMETER WAS 5MM, AND LESION LENGTH 200MM. A 6FR NON-MEDTRONIC SHEATH AND NITREX 0.014 300CM WAS USED. NO EMBOLIC PROTECTION USED. IFU WAS FOLLOWED. IT WAS REPORTED THAT UPON WITHDRAWAL OF THE DEVICE MILD RESISTANCE WAS FELT BY THE PHYSICIAN WITHIN THE CONTRALATERAL SHEATH. THE DEVICE THEN SEPARATED APPROXIMATELY AT THE AREA OF THE CUTTER WINDOW. THE DEVICE WAS WITHIN THE SHEATH. THE SHEATH WAS THEN REMOVED FROM THE PATIENT WITH THE SEPARATED PIECE WITHIN THE SHEATH. A NEW SHEATH WAS PLACED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT, WITH COMPLETE REMOVAL OF THE SEPARATED PORTION OF THE DEVICE. RESISTANCE FELT WAS MINIMAL. PROCEDURE WAS COMPLETED WITH NEW HAWKONE (H1-S) DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314303 ↗
• MalfunctionJun 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN ATTEMPTED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 100MM PLAQUE LESION IN THE PATIENT¿S MID LEFT POSTERIOR TIBIAL ARTERY. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 3MM. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. IT IS REPORTED THE CUTTER WOULD NOT FULLY CLOSE AS IT WAS JAMMED. THE CUTTER WAS OUTSIDE THE HOUSING FOR REMOVAL OF THE DEVICE FROM THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PHYSICIAN BALLOONED AND FINISHED THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038733 ↗
• InjuryMay 31, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 6 FR NON-MEDTRONIC SHEATH AND 0.014 GUIDEWIRE DURING TREATMENT OF A PLAQUE LESION LOCATED DISTALLY IN THE ARTERY. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED. IT IS REPORTED MODERATE RESISTANCE WAS NOTED AT THE SHEATH DURING WITHDRAWAL OF THE DEVICE LEADING TO A TIP DETACHMENT. THE PHYSICIAN BELIEVED THE DEVICE WAS POTENTIALLY OVER PACKED AND HUNG UP ON THE DISTAL TIP OF THE SHEATH. THE TIP WAS SNARED OUT OF PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907068 ↗

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-0450-2022 · Dec 6, 2021 · Terminated
  Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The Haw