SpiderFX™ SPD2-US-040-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00821684068328), received between Mar 30, 2017 and Sep 5, 2024 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Fracture; Fracture

  A PHYSICIAN INTENDED TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE DURING PATIENT TREATMENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A DISTAL FRACTURE OFTHE PRODUCT WAS REPORTED DURING PROCEDURE, THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT.  A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143376 ↗
• InjuryJul 11, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A PHYSICIAN WAS ATTEMPTING TO USE A SPIDER FX TO TREAT THE PERIPHERAL ARTERY, TIBIAL/POPLITEAL TRUNK. THERE WAS MINIMAL TORTUOSITY. FEM-POP BYPASS WAS REPORTED IN RELATION TO ANATOMY. A 6F COOK ANSEL SHEATH AND A .035 260CM GLIDEWIRE ADVANTAGE GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS USED. THE VESSEL WAS NOT PRE-DILATED AND POST DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED. THE 4MM SPIDER WAS DELIVERED OVER THE WIRE TO THE PERONEAL ARTERY. THE GREEN CATHETER WAS ADVANCED DOWN TO THE PERONEAL AND THE CROSSING WIRE WAS REMOVED. THE FILTER WAS PUSHED FORWARD UNTIL IT REACHED THE LEVEL OF THE TPT (STILL INSIDE THE DELIVERY CATHETER) BUT WOULD NOT GO FURTHER. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY CATHETER BUT ENCOUNTERED RESISTANCE. ADVANCING X-RAY OVER THE GROIN REVEALED A WIRE PROLAPSE IN THE COMMON FEMORAL ARTERY, WHICH WAS ENLARGED DUE TO A BOVINE PATCH. THIS RESULTED IN INTERVENTION FOR REMOVAL OF DEVICE. THE PHYSICIAN ENCOUNTERED TROUBLE TRYING TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721674 ↗
• InjuryApr 5, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  PHYSICIAN ATTEMPTED TO USE A HAWKONE M ATHERECTOMY DEVICE WITH A 65CM 6FR NON-MEDTRONIC SHEATH AND A 4MM SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING PROCEDURE TO TREAT A CALCIFIED FIBROUS PLAQUE LESION IN THE PATIENTS LEFT PROXIMAL MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) <(>&<)> POPLITEAL ARTERY. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. A 4X80MM CHOCOLATE PTA BALLOON WAS USED FOR PRE-DILATION. THE VESSEL WAS POST-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. RESISTANCE AND REMOVAL DIFFICULTIES WERE REPORTED. THE NOSECONE DETACHED FROM THE HAWKONE. IT WAS REPORTED NOTHING DETACHED FROM THE SPIDER AND REMAINED INTACT UPON REMOVAL. A CUT-DOWN WAS REQUIRED TO REMOVE THE SPIDER, NOSECONE AND SHEATH AND THE COMMON FEMORAL WAS PATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049850 ↗
• InjuryJul 2, 2023Entrapment of Device; Entrapment of Device

  A PHYSICIAN WAS USING A HAWKONE ATHERECTOMY DEVICE FOR TREATMENT OF A CALCIFIED LESION WITH 90% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. A SPIDER FX WIRE WAS ALSO USED. THERE WAS MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE VESSEL WAS NOT PRE OR POST DILATED. THE IFU WAS FOLLOWED. IT WAS REPORTED DURING WITHDRAWAL SEVERE RESISTANCE WAS FELT AS A RESULT OF A WIRE WRAP THE DEVICE COULD NOT BE REMOVED AND THE TIP DETACHED AT THE HINGE PIN. A SNARE WAS USED FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244495 ↗
• InjuryJul 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A SPIDER FX DEVICE WAS RETURNED TO THE LAB, WHERE THE GREEN DELIVERY CATHETER APPEARS TO HAVE BROKEN IN VIVO AT THE PRIMARY EXIT PORT. IT SEEMS THAT IT WAS SNARED BY A COMPETITORS SNARE TO BE RECOVERED. THE SPIDER FX FILTER WAS LOCATED IN THE TRANSPARENT SECTION OF THE DELIVERY CATHETER. ALL COMPONENTS ARE ACCOUNTED FOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342898 ↗
• MalfunctionApr 8, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A SPIDER FX COMPLAINT WAS RECEIVED AND IT WAS REPORTED THERE WAS NOT A PRODUCT ISSUE BUT THE PHYSICIAN HAD SELECTED THE INCORRECT SIZE FOR TREATMENT. THE DEVICE WAS RECEIVED FOR ANALYSIS AND IT WAS CONFIRMED THE DEVICE WAS USED IN THE PATIENT DUE TO THE PRESENCE OF BIOLOGICAL DEBRIS. THE DISTAL ASSEMBLY WAS VISUALIZED AS BEING LOOSE WITHIN THE POUCH. THE SPIDER FX CAPTURE WIRE HAD SNAPPED JUST PROXIMAL OF THE SPIDER FX FILTER. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN WHEN THE DETACHMENT OCCURRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9937262 ↗
• MalfunctionAug 21, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PHYSICIAN USED A SPIDER FX WITH A 7FR X 65CM SHEATH DURING TREATMENT OF A CALCIFIED AND PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID AND DISTAL LEFT TIBIAL/POPLITEAL TRUNK. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. A HAWKONE ATHERECTOMY DEVICE AND TRAILBLAZER SUPPORT CATHETER WERE ALSO USED DURING THE PROCEDURE. IFU WAS FOLLOWED DURING PREPARATION AND PROCEDURE. PRE-DILATION WAS PERFORMED. PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS REPORTED ON REMOVAL SPIDER FILTER A PIECE OF LONG PLASTIC WAS OBSERVED IN/OUT OF THE FILTER. THE ORIGIN OF THE PLASTIC IS UNKNOWN. POST-DILATION PERFORMED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915480 ↗
• InjuryNov 20, 2018Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE THE HAWKONE WITH A TERUMO 6F SHEATH AND SPIDER FX, TO TREAT A MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY AS PER IFU. ARTERY DIAMETER 6MM, LESION LENGTH 200MM. IT WAS REPORTED DIFFICULTIES WERE ENCOUNTERED ADVANCING THE DEVICE THROUGH A HEAVY CALCIUM IN THE MID SFA, DURING REMOVAL THE NOSECONE DETACHED. THE PHYSICIAN ATTEMPTED TO SNARE THE NOSECONE BUT WAS UNSUCCESSFUL. A CUTDOWN WAS NEEDED ON THE LEFT ILIAC TO REMOVE THE NOSECONE, AN ENDARTERECTOMY WAS PERFORMED, AND STENTS WERE IMPLANTED. NO ALLEGATION AGAINST SPIDER FX.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8090105 ↗
• InjuryNov 2, 2018Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  A RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE MID CORONARY SVG TO DIAGONAL GRAFT. THE LESION EXHIBITED 70% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES REPORTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT DURING DELIVERY TO/AT THE LESION THAT A STENT DISLODGMENT OCCURRED IN THE FEMORAL ARTERY. IT IS SUSPECTED THAT THE SPIDER FX WAS POSITIONED TOO SHALLOW IN THE VESSEL, AND THE STENT WAS ADVANCED FORWARD TO THE POINT WHERE IT ENTERED THE SPIDER FX BASKET. UPON PULLING THE STENT/BALLOON BACK, IT IS BELIEVED THE STENT LODGED IN THE SPIDER FX BASKET AND THE BALLOON WAS PULLED OFF THE STENT. THE DEVICE BALLOON WAS REMOVED FIRST. THE STENT WAS CAPTURED INTO THE SPIDER FX BASKET. THE SPIDER FX BASKET AND STENT WERE THEN DRAWN TO THE TIP OF A 6 FRENCH GUIDE. UPON THE INITIAL ATTEMPT AT REMOVAL, THE NON-MEDTRONIC GUIDE, STENT AND SPIDER FX WERE PULLED AS ONE UNIT THROUGH THE 6 FRENCH SHEATH; HOWEVER, THE ATTE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8032256 ↗
• InjuryMar 27, 2018Kinked; Detachment of Device or Device Component; Kinked; Detachment of Device or Device Component

  PHYSICIAN USED A SPIDER FX WITH A NON-MDT 7F SHEATH DEVICE DURING TREATMENT OF A SEVERELY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL DESCRIBED AS BEING SLIGHTLY TORTUOUS. LESION EXHIBITED 75% STENOSIS. IFU WAS FOLLOWED. VESSEL WAS NOT PRE-DILATED. A SPIDER WAS USED IN THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED A FULL DEPLOYMENT OF THIS DEVICE BUT DEPLOYMENT DIFFICULTIES WERE EXPERIENCED AND THE DEVICE WAS REMOVED FROM THE PATIENT. UPON REMOVAL IT WAS OBSERVED THAT A PIECE OF THE GREEN DEPLOYMENT CATHETER WAS MISSING (END OF CATHETER DETACHED FROM REST OF CATHETER PROXIMAL TO CLEAR HOUSING OF CATHETER). THE CATHETER DID NOT BREAK INTO MULTIPLE PIECES AND THE DEPLOYMENT TIP WAS OBSERVED TO BE IN THE PROXIMAL STA. THE DETACHED PORTION WAS RETRIEVED USING A SNARE AND PTA WAS CARRIED OUT POST REMOVAL OF DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7373993 ↗
• InjuryMar 2, 2018Kinked; Difficult to Remove; Activation, Positioning or Separation Problem; Kinked; Difficult to Remove; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE SPIDER FX EMBOLIC PROTECTION CATHETER AND H1-LS DIRECTIONAL ATHERECTOMY TO AID IN THE TREATMENT OF A MODERATELY CALCIFIED PLAQUE LESION IN THE RIGHT PROXIMAL POPLITEAL ARTERY. THE VESSEL WAS MODERATELY TORTUOUS. BOTH DEVICES WERE PREPPED. THE SPIDER WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS ADVANCED WITH NO ISSUES OVER AN .014 WIRE AND WAS PROPERLY LOADED. THE VESSEL WAS PRE AND POST DILATED. IT WAS REPORTED THE PHYSICIAN EXPERIENCED DIFFICULTY RETRIEVING THE DEVICE BACK INTO THE GREEN DELIVERY FILTER AS IT HAD FLIPPED UPSIDE DOWN DURING DEPLOYMENT. FORCE HAD BEEN APPLIED BEFORE THE PHYSICIAN NOTED THE FLIPPED FILTER. THE PHYSICIAN REPORTED HE PULLED THE SPIDER WIRE BACK HARDER THAN NORMAL WHILE PUSHING THE GREEN CATHETER AND IT EVENTUALLY POPPED BACK INTO THE CATHETER. IT WAS REPORTED THAT A DISSECTION OCCURRED, AND THE PHYSICIAN WASN¿T COMFORTABLE HAWKING ON A DISSECTION. THE PHYSICIAN PERFORMED ORBITAL ATHERECTOMY, STENTING AND BALLOON ANGIOPLASTY IN THE TIBIAL ARTERIES USING NON-MEDTRONIC DEVICES TO COMPLETE THE PROCEDURE. THERE IS NO ALLEGATION AGAINST THE HAWKONE DEVICE.

  Patient problems: Intimal Dissection

  MAUDE report 7309167 ↗
• MalfunctionOct 5, 2017Break; Material Deformation; Break; Material Deformation

  PHYSICIAN INTENDED TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE DURING A PROCEDURE. IT WAS REPORTED THAT IFU WAS FOLLOWED, BUT DURING THE PROCEDURE THE WIRE WAS BROKEN. AS THE PHYSICIAN FELT THAT THE SPIDER FX DEVICE COULD NOT BE USED, THE DEVICE WAS REPLACED WITH ANOTHER ONE TO CONTINUE THE PROCEDURE. NO . NO PATIENT INJURY REPORTED, AND NO INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6916557 ↗
• MalfunctionSep 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A SPIDER FX EMBOLIC PROTECTION DEVICE. THE IFU WAS FOLLOWED DURING PREP, PROCEDURE AND POST PROCEDURE. IT WAS REPORTED THAT THE EVENT WAS ''NOTED AS FAILURE'' AS THE BASKET WOULD NOT RETURN TO THE RETRIEVAL CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6862280 ↗
• InjurySep 2, 2017Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN USED A SPIDER FX EMBOLIC PROTECTION DEVICE DURING A PROCEDURE TO TREAT THE SFA. IT WAS REPORTED THAT THE SPIDER FILTER DETACHED FROM THE WIRE FOLLOWING LASERING AND PTA BALLOONING OF THE LESION. THE DETACHED PORTION WAS SUCCESSFULLY RETRIEVED BY THE PHYSICIAN WITH A SNARE, HOWEVER DURING THE RETRIEVAL IT WAS REPORTED THAT THE PHYSICIAN ¿DINGED UP A STENT¿ AND THEN LATER LOST BLOOD FLOW TO THE VESSEL. THIS WAS A PRE-EXISTING CORONARY STENT USED AS A ¿BAILOUT¿ IN THE TPT TRUNK, PLACED IN 2015. IT WAS REPORTED THAT THE SPIDER FX DEVICE MAY HAVE GOTTEN TETHERED OR PULLED BY THE STENT THAT THE "DINGING OF THE STENT" OR THE LONGITUDINALLY COMPRESSION LIKELY CAME LATER AS A RESULT OF THE SNARE ATTEMPTS. THE STENT IS STILL IN SITU. BLOOD FLOW WAS LOST ANTEGRADE DOWN THE VESSEL. ATTEMPTS WERE MADE TO RESTORE THE BLOOD FLOW, BUT UNABLE TO GET THROUGH THE STENT. PHYSICIAN SUSPECTED THAT THE SUBINTIMAL ENTRY OF THE GUIDEWIRE MAY HAVE CAUSED INTRAMURAL HEMATOMA WITH LOSS OF FLOW. IT WAS REPORTED THAT THE BLOOD FLOW TO THE VESSEL WAS COMPROMISED WHILE MANIPULATING THE STENT TO OPTIMIZE THE PROXIMAL EXPANSION; IT WAS NOT DIRECTLY DUE TO THE SPIDER OR THE SNARE. MULTIPLE ATTEMPTS WERE M

  Patient problems: Occlusion

  MAUDE report 6840549 ↗
• MalfunctionJul 17, 2017Break; Break

  PHYSICIAN WAS USING A SPIDER FX FILTER ALONG WITH A TURBOHAWK DIRECTIONAL ATHERECTOMY DEVICE FOR TREATMENT OF A MINIMALLY TORTUOUS, SLIGHTLY CALCIFIED LESION. NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THAT THE SPIDER WAS BROKEN IN THE PATIENT DURING THE PROCEDURE. A PHYSICIAN RETRIEVED IT AND REPLACED IT WITH ANOTHER MEDTRONIC PRODUCT. THE PROCEDURE WAS COMPLETED. NO INTERVENTION WAS REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6720398 ↗
• MalfunctionApr 13, 2017Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO TREAT A LESION IN THE LEFT SFA USING HAWKONE ATHERECTOMY AND SPIDER DISTAL EMBOLIC PROTECTION. IT WAS REPORTED THAT A KINK OCCURRED WITH THE SPIDER DEVICE DURING THE SECOND WITHDRAWAL. RESISTANCE WAS FELT DURING WITHDRAWAL. THE KINK WAS OBSERVED AT SHEATH TIP. THE GUIDE WIRE WAS ALSO KINKED. THE ATHERECTOMY WAS ADVANCED OVER A BIFURCATION AND GUIDE WIRE ADVANCEMENT/PROLAPSE/LOCK-UP OCCURRED. MODERATE RESISTANCE WAS FELT DURING WITHDRAWAL. TIP WAS DAMAGED. GUIDE WIRE LUMEN TORN FROM DISTAL TIP. PROLAPSE OCCURRED DURING DEVICE REMOVAL FOR CLEANING. SHEATH, WIRE AND DEVICE WERE REMOVED IN UNISON LEAVING A DISTAL PORTION ON SPIDER IN CONTRALATERAL VESSEL. COAXIAL CATHETERS WERE USE TO REPLACE SHEATH AND NEW SPIDER AND DEVICE WERE USED TO FINISH PROCEDURE. PROLAPSE OCCURRED DURING DEVICE REMOVAL FOR CLEANING. THE TWO DEVICES WERE REMOVED IN TANDEM. THE LESION WAS SEVERELY CALCIFIED AND TOTALLY OCCLUDED, VESSEL WAS MODERATELY TORTUOUS. THE VESSEL WAS PRE AND POST DILATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6489630 ↗
• InjuryMar 30, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PHYSICIAN USED THE SPIDER FX DURING A PROCEDURE TO TREAT THE POPLITEAL ARTERY AS PER IFU. IT WAS REPORTED WHEN ATTEMPTING TO RECAPTURE THE FILTER WIRE, THE FILTER BECAME DETACHED FROM THE WIRE. A GOOSENECK SNARE WAS USED TO SNARE THE FILTER AND PULL IT BACK INTO THE SHEATH. ALL THE DEVICES WERE REMOVED FROM THE PATIENT AS A UNIT. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6445554 ↗