SpiderFXRecalls & reported problems across all models

We found 8 models of SpiderFX by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 170 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Jul 15, 2026 — classified as 1 death, 93 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (91 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 SpiderFX problems

SpiderFX models

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

• SpiderFX™ SPD2-US-060-320

  Temporary Carotid Catheter for Embolic Capture
  1 death57 reports
• SpiderFX™ SPD2-US-050-320

  Temporary Carotid Catheter for Embolic Capture
  56 reports
• SpiderFX™ SPD2-US-070-320

  Temporary Carotid Catheter for Embolic Capture
  27 reports
• SpiderFX™ SPD2-US-040-320

  Temporary Carotid Catheter for Embolic Capture
  17 reports
• SpiderFX™ SPD2-US-030-320

  Temporary Carotid Catheter for Embolic Capture
  9 reports
• SpiderFX™ SPD2-US-030-190

  Temporary Carotid Catheter for Embolic Capture
  2 reports
• SpiderFX™ SPD2-US-050-190

  Temporary Carotid Catheter for Embolic Capture
  1 report
• SpiderFX™ SPD2-US-060-190

  Temporary Carotid Catheter for Embolic Capture
  1 report

Recent SpiderFX adverse event reports

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

• InjuryJul 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING AN INVASIVE VASCULAR PROCEDURE/ AORTOGRAM WITH RUNOFFS IT WAS REPORTED THE DISTAL WIRE OF THE SPIDER FX DETACHED INTO THE DISTAL POPLITEAL ARTERY. A GOOSENECK SNARE WAS USED TO SUCCESSFULLY REMOVE THE DETACHED COMPONENT. NO RESIDUAL FOREIGN BODY REMAINED IN THE BODY. PATIENT WAS DISCHARGED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 25825241 ↗
• InjuryJun 30, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE USING THE SPIDER FX EMBOLIC PROTECTION DEVICE TO TREAT A CALCIFIED TARGET LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, THE SPIDER WIRE DETACHED AT THE SNAP POINT WITHIN THE SHEATH. THE SPIDER FILTER WAS NOT OVERFILLED AND THE DEVICE WAS INTACT ON REMOVAL. THE TARGET VESSEL WAS DESCRIBED AS HAVING MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE DETACHED COMPONENT WAS REMOVED BY SNARING. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25663110 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A SPIDER FX DEVICE HAD A SPIDER COMPONENT DETACH WITHIN THE SHEATH WHILE THE DEVICE WAS BEING REMOVED AS THE PROCEDURE WAS REACHING COMPLETION. THE DETACHED SPIDER COMPONENT WAS REMOVED WITHIN THE SHEATH, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24950919 ↗
• InjuryApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY INTERVENTION USING THE SPIDER FX EMBOLIC PROTECTION DEVICE IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, THE BASKET COMPONENT DETACHED WITHIN THE SHEATH. THE TARGET LESION WAS DESCRIBED AS PLAQUE WITH MINIMAL TORTUOSITY, MODERATE CALCIFICATION, CHRONIC TOTAL OCCLUSION, A LESION LENGTH OF 200 MM, AND A VESSEL DIAMETER OF 6 MM. A 7FR NON MEDTRONIC SHEATH WAS USED, EMBOLIC PROTECTION WAS USED, THE VESSEL WAS NOT PRE-DILATED, AND THE VESSEL WAS POST-DILATED WITH AN EVERCROSS 5X150 DEVICE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, THERE WAS NO REPORTED PACKAGING DAMAGE OR ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY, AND THE INSTRUCTIONS FOR USE WERE REPORTEDLY FOLLOWED WITHOUT ISSUE. A CUT-DOWN WAS PERFORMED TO REMOVE THE DETACHED BASKET, THE DEVICE WAS REPORTEDLY SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24938319 ↗
• MalfunctionMar 13, 2026Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TREATMENT OF A PLAQUE LESION IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY USING THE SPIDER FX EMBOLIC PROTECTION DEVICE, A KINK WAS NOTED AT THE MID WIRE DURING THE PROCEDURE AND THE WIRE SNAPPED ALONG THE BREAK POINT, WHICH APPEARED TO BE DUE TO PHYSICIAN MISHANDLING. IT DID NOT HAVE AN IMPACT ON PATIENT TREATMENT. ARTERY DIAMETER REPORTED AS 6MM. THE VESSEL WAS POST-DILATED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW NON-MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594316 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF PERIPHERAL ARTERY PLAQUE IN THE MID RIGHT TIBIAL/POPLITEAL TRUNK, THE SPIDER FX DEVICE WIRE BROKE AT THE BREAK POINT INTO THE CXI CATHETER. THE RETRIEVAL CATHETER PROVIDED WITH THE SPIDER DEVICE WAS USED TO CAPTURE THE BROKEN SPIDER DEVICE, AND A NEWLY OPENED SPIDER DEVICE WAS DEPLOYED WITHOUT ISSUE. THE VESSEL HAD MINIMAL TORTUOSITY AND CALCIFICATION, WITH A DIAMETER OF 4 MM. THE SHEATH USED WAS A 6FR TERUMO PINNACLE, AND POST-DILATION WAS PERFORMED WITH A BOSTON STERLING DEVICE. THERE WERE NO ABNORMALITIES IN ANATOMY, NO RESISTANCE ENCOUNTERED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC SPIDER DEVICE. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590231 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING RETRIEVAL, THE WIRE OF THE EP SPD2-US-050-320 SPIDER FX WAS CUT INSIDE THE GUIDING CATHETER. IT IS NOT KNOWN HOW THE DETACHED COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290308 ↗
• MalfunctionFeb 5, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A SEVERE CALCIFIED LESION IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (PERIPHERAL ARTERY) USING THE EP SPD2-US-060-320 SPIDER FX, A FILTER RECOVERY ISSUE OCCURRED WHEN THE FILTER CAME OFF THE DEVICE AS IT WAS RETRACTED INTO THE CAPTURE CATHETER. THE VESSEL DIAMETER WAS 6MM AND EMBOLIC PROTECTION WAS USED WITH THE SPIDERFX 6.0MM DEVICE. THE VESSEL WAS BOTH PRE-DILATED AND POST-DILATED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND NO RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PHYSICIAN OBTAINED ACCESS AT A NEW SITE TO COMPLETE THE PROCEDURE. THE DETACHMENT OCCURRED WITHIN THE SHEATH. THE SHEATH WAS REMOVED WITH THE DETACHED PART OF THE SPIDER STILL INTACT WITHIN THE SHEATH. NO OTHER INCIDENT FOLLOWED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267297 ↗
• InjuryFeb 4, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE EP SPD2-US-050-320 SPIDER FX DEVICE, A PATIENT EXPERIENCED A 30-MINUTE DELAY IN SURGERY DUE TO A PRODUCT MALFUNCTION. THE PROCEDURE TARGETED A 100% STENOSED LESION WITH PLAQUE LOCATED IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, WITH A LESION LENGTH OF 200MM AND ARTERY DIAMETER OF 7MM. MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. A 7X40 NON-MEDTRONIC SHEATH WAS USED. THE VESSEL WAS POST-DILATED WITH A 6X80 EVERCROSS PTA BALLOON. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN RETRIEVING THE DEVICE. THE DISTAL PART OF SPIDER DETACHED AND REMAINS OF THE PRODUCT WERE LEFT ON THE STENT. THE DEPLOYED STENT WAS ALTERED AND CORRECTED BY STENT OVERLAP AND PTA. THE RESIDUAL MATERIAL/ENDO-TRASH WAS STENTED OVER AND THE PROCEDURE WAS COMPLETED. NO VESSEL DAMAGE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258180 ↗
• InjuryDec 19, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL VASCULAR INTERVENTION USING THE SPIDERFX FILTER, SEVERE CALCIFICATION, AND >75% STENOSIS OF A 60MM LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY/PROXIMAL POPLITEAL ARTERY, THE PHYSICIAN EXPERIENCED DIFFICULTY FULLY COLLAPSING AND CAPTURING THE SPIDERFX FILTER INTO A TRAILBLAZER CATHETER AFTER LESION TREATMENT. THE DEVICE HAD PASSED THROUGH A PREVIOUSLY DEPLOYED PROTEGE EVERFLEX. A NANOCROSS WAS USED FOR POST-DILATION. THE TRAILBLAZER CATHETER BECAME CAUGHT ON THE DISTAL END OF A 7FR NON MEDTRONIC SHEATH PARKED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY AND COULD NOT BE PULLED THROUGH. AN ATTEMPT WAS MADE TO MAINTAIN VESSEL ACCESS WITH A 0.035" STIFF ANGLED GLIDEWIRE AND TO REPLACE THE SHEATH, BUT UPON REMOVAL, THE SPIDERFX FILTER BECAME CAUGHT AT THE LEFT COMMON FEMORAL ARTERIOTOMY SITE AND COULD NOT BE RETRIEVED. FURTHER ATTEMPTS TO RECAPTURE THE FILTER RESULTED IN THE FILTER SNAPPING OFF THE WIRE AND REMAINING WITHIN THE PATIENT'S SOFT TISSUES. SURGICAL CUTDOWN ON THE LEFT GROIN WAS REQUIRED TO RETRIEVE THE FILTER, AND CONTRALATERAL GROIN ACCESS WAS OBTAINED TO PLACE A COVERED STENT AT THE LEFT COMMON FEMORAL ARTERIOTOMY SITE. POST

  Patient problems: Insufficient Information

  MAUDE report 23851467 ↗
• InjuryDec 14, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EP SPD2-US-070-320 SPIDER FX TO TREAT A CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL MID DISTAL COMMON FEMORAL ARTERY, EXTERNAL ILIAC ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS MODERATE. LESION LENGTH WAS 60MM. ARTERY/VEIN DIAMETER WAS 9MM. LESION LOCATION WAS A FORMER SURGICAL SITE, ARTERIOTOMY. A 8 DESTINATION SHEATH WAS USED. DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED MEDTRONIC GPS. SEVERE RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE USED. BUDDY WIRE WAS PLACED WITH SPIDER PRIOR TO REMOVAL AND SPIDER WAS PULLED INTO SHEATH WITH INTENT TO REMOVE WITH THE SHEATH, BUT THE WRONG WIRE WAS PULLED AND THE SPIDER REMAINED. SPIDER BASKET DETACHED WITHIN THE VESSEL WHEN FORCED TO PULL. TACKED TO VESSEL WALL. REMAINS IMPLANTED IN PATIENT WITH COVERED STENT SECURING ITS LOCATION. UNABLE TO RETRIEVE WITH SNARE OR BIOPSY FORCEPS.

  Patient problems: Insufficient Information

  MAUDE report 23799513 ↗
• MalfunctionDec 9, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS A FILTER RECOVERY ISSUE ASSOCIATED WITH THE SPIDER FX EMBOLIC PROTECTION DEVICE DURING A PROCEDURE INVOLVING THE CAROTID ARTERY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE SPIDER FILTER WAS NOT OVER-FILLED. THE DEVICE WAS INTACT UPON REMOVAL AND WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755689 ↗
• InjurySep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE SPIDER FX EMBOLIC PROTECTION DEVICE, MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE THROUGH A SEVERELY CALCIFIED TARGET LESION WITH 90% STENOSIS AND MODERATE VESSEL TORTUOSITY IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY. THE DEVICE TIP AND BASKET DETACHED WITHIN THE VESSEL. THE DETACHED COMPONENTS WERE SNARED AND REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22991289 ↗
• InjuryAug 29, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (MODERATE CALCIFICATION, 60MM LESION LENGTH, 7MM ARTERY DIAMETER) WITH THE SPIDER FX, THE SPIDER BASKET/FILTER DETACHED FROM THE WIRE WITHIN THE SHEATH. A TIGHT FIT WAS NOTED ONCE THE SPIDER BASKET ENTERED THE SHEATH. THE DETACHED BASKET/FILTER WAS SNARED AND SAFELY REMOVED. THE PROCEDURE WAS COMPLETED AT THE END OF THE CASE AFTER REMOVAL OF THE FILTER BASKET FROM THE PATIENT'S SUPERFICIAL FEMORAL ARTERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22920915 ↗
• InjuryJul 2, 2025Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SPIDER FX AND THE STENT PROTEGE RX, A PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO COMPLICATIONS ENCOUNTERED IN THE LEFT DISTAL COMMON CAROTID ARTERY, WHICH HAD AN 80% STENOTIC PLAQUE AT THE TARGET LESION. THE PATIENT¿S VASCULAR ANATOMY WAS DESCRIBED AS SEVERELY TORTUOUS, INCLUDING ARCH ANATOMY TORTUOSITY AND A TORTUOUS INTERNAL CAROTID ARTERY. DURING THE PROCEDURE, THE SPIDER FX FILTER BECAME ENTRAPPED WITHIN THE STENT AND COULD NOT BE REMOVED ENDOVASCULARLY. THIS RESULTED IN REMOVAL DIFFICULTIES, REQUIRING A SURGICAL CUTDOWN FOR DEVICE RETRIEVAL. THE PATIENT WAS SUBSEQUENTLY TAKEN TO SURGERY FOR STENT AND SPIDER FX REMOVAL VIA CAROTID ENDARTERECTOMY. VESSEL DAMAGE WAS NOTED AS A CUTDOWN WAS PERFORMED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE THAT WAS NOT A MEDTRONIC PRODUCT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22385625 ↗

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