SpiderFX™ SPD2-US-030-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821684068304), received between Dec 15, 2017 and Jul 15, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, 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 ↗
• MalfunctionNov 16, 2022Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX DURING TREATMENT OF A 100MM PLAQUE LESION WITH 80% STENOSIS IN THE PERONEAL ARTERY. THE ARTERY HAS MILD TORTUOSITY AND MODERATE CALCIFICATION. THE IFU WAS FOLLOWED. IT WAS REPORTED DURING THE INITIAL ADVANCEMENT A KINK WAS OBSERVED 20 CM DISTAL TO THE FILTER (APPROXIMATELY). THE DEVICE WAS REMOVED. THE DEVICE WAS ADVANCED AGAIN POST DILATION VIA A SUPPORT CATHETER. UPON REMOVAL IT WAS NOTED THAT THE TIP WIRE WAS DISCONNECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804587 ↗
• InjuryOct 9, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  PHYSICIAN INTEND TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE WITH A 6FR NON-MEDTRONIC SHEATH AND 0.018 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, AND TIBIAL/POPLITEAL TRUNK. IFU WAS FOLLOWED. PRE-DILATION WAS NOT PERFORMED. IT IS REPORTED THAT THE SPIDER WAS DELIVERED OVER THE 0.018 NON-MEDTRONIC WIRE (THE FILTER WAS PULLED BACK INTO APPROPRIATE WINDOW TO ALLOW FOR NO WIRE INTERACTION). THE SPIDER FX WAS ADVANCED SMOOTHLY TO THE TARGET AREA AND THE 0.018 WIRE WAS REMOVED WITHOUT ISSUE. THE PHYSICIAN THEN BEGAN ADVANCING THE FILTER WIRE AND NO ISSUES WERE NOTED. WHEN THE PHYSICIAN LOOKED ON FLUORO, IT WAS OBSERVED THAT THE FILTER HAD NOT ADVANCED AND UNDER FLUORO THE SPIDER WOULD NOT ADVANCE PAST MARKER (BELIEVE THAT IS WHERE RX EXIT PORT IS LOCATED). THE TIP OF WIRE LOOKED TO HAVE AN ANGLE ON IT AND WANTING TO EXIT THAT PORT UNDER FLUORO. IT WAS DECIDED THAT REMOVE THE FILTER AND DELIVERY CATHETER FROM PATIENT. THE CATHETER WOULD NOT COME BACK INTO SHEATH, IT COULD BE ADVANCED BUT NOT COME BACK WITHOUT EXTREME FORCE. UPON INVESTIGATION UNDER FLUORO IT WAS NOTICED THAT THE SPIDER WIRE ITSE

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10654904 ↗
• InjuryApr 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A SPIDER FX WITH A 6FR SHEATH DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY, POSTERIOR TIBIAL ARTERY, AND ANTERIOR TIBIAL ARTERY. MODERATE VESSEL CALCIFICATION IS REPORTED. VESSEL PRE-DILATED WAS CARRIED OUT. IFU WAS FOLLOWED. THERE WERE NO DIFFICULTIES DURING PLACEMENT AND EXPANSION OF THE SPIDER IT IS REPORTED THE FILTER DETACHED FROM THE WIRE INSIDE THE PATIENT DURING REMOVAL THROUGH A 0.035 TRAILBLAZER DEVICE. THE FILTER FRACTURED DURING RETRIEVAL AND A STENT WAS PLACED TO MITIGATE PROPAGATION OF FILTER. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9935469 ↗
• MalfunctionNov 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A 3MM SPIDER FX WITH A NON-MEDTRONIC (COOK ANSEL) 6FR SHEATH AND NON-MEDTRONIC (ABBOTT COMMAND) .014 GUIDEWIRE DURING TREATMENT OF A 20MM, 70% CALCIFIED LESION IN THE PATIENTS PROXIMAL LEFT POSTERIOR TIBIAL ARTERY AND TIBIAL/POPLITEAL TRUNK. VESSEL DIAMETER REPORTED AS 3MM. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THE REAR PORTION OF SPIDER FX CATHETER BROKE INTO 2 SEGMENTS BUT REMAINED ON THE FILTER WIRE. THE BROKEN SEGMENTS WERE SUCCESSFULLY RETRIEVED INTO THE SHEATH AND REMOVED OVER THE NON-MEDTRONIC WIRE .014 WIRE. IT IS REPORTED THAT DIFFICULTY HAD BEEN EXPERIENCED WHEN GETTING THE WIRE TO EXIT THE PROXIMAL PORT. IT IS BELIEVED THE CATHETER MAY HAVE BEEN KINKED TRYING TO OPEN THE PORT, SO THE WIRE COULD EXIT MORE EASILY. THE PHYSICIAN THEN PLACED A NEW 6FR 55CM SHEATH AND REWIRED THE LESION WITH A NEW NON-MEDTRONIC WIRE. THE LESION WAS BALLOONED. THE PHYSICIAN WAS SATISFIED WITH THE RESULT. ADDITIONAL ANGIOGRAMS WERE CARRIED OUT TO ENSURE NO DAMAGE TO PATIENT VASCULATURE. ANGIOGRAM CONFIRMED GOOD FLOW DISTALLY TO THE FOOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102031 ↗
• MalfunctionApr 24, 2018Break; Break

  PHYSICIAN USED A SPIDER FX DEVICE WITH A 7FR NON-MDT SHEATH DURING TREATMENT OF A 250MM SLIGHTLY CALCIFIED LESION IN THE DISTAL RIGHT PERONEAL ARTERY OF DIAMETER 4MM. LESION EXHIBITED 90% STENOSIS. THE VESSEL DESCRIBED AS BEING SLIGHTLY TORTUOUS. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. THE SPIDER FX DEVICE WAS DEPLOYED THROUGH A .035-150CM TRAILBLAZER CATHETER. WHEN THE SPIDER FX WAS CLOSE TO THE TARGET LOCATION, IT WAS NOTED THE WIRE WAS TOO SHORT COMING OUT OF THE TRAILBLAZER. IT WAS ASSUMED BY THE PHYSICIAN THAT THE WIRE WAS SNAPPED INSIDE OF THE RING BECAUSE THE BACK PART OF THE WIRE WAS NEVER VISIBLE OUTSIDE OF THE RING. THE DEVICE WAS REMOVED AND A DIFFERENT SPIDER FX (SAME SIZE) WAS DEPLOYED SUCCESSFULLY TO COMPLETE THE CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7453439 ↗
• InjuryJan 25, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE PATIENT WENT TO THE CARDIAC CATH LAB FOR PLANNED RIGHT AND LEFT HEART CATHETERIZATION DUE TO HER SUB-TOTAL OCCLUSION OF HER RIGHT CORONARY ARTERY. AN UNKNOWN STENT HAD INITIALLY BEEN PARTIALLY DEPLOYED TO THE RIGHT CORONARY ARTERY WITH A SPIDER FX WIRE FILTER DEVICE FOR DISTAL EMBOLIC PROTECTION, GIVEN THE LARGE THROMBUS BURDEN AT RISK OF EMBOLIZATION. DUE TO DIFFICULTY PASSING POST-DILATATION BALLOONS FOR FINAL STENT EXPANSION, A DECISION WAS MADE TO PROCEED TO REMOVE THE SPIDERFX WIRE FILTER. THE CAPTURE SHEATH OF THE FILTER SPIDERFX WIRE BECAME CAUGHT ON THE PROXIMAL EDGE OF THE STENT AND THEN THE STENT, FILTER WIRE AND CAPTURE SHEATH WERE REMOVED FROM THE CORONARY ARTERY. THE CAPTURE SHEATH WAS THEN REMOVED FROM THE BODY. HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE STENT-FILTER COMBINATION THROUGH THE FEMORAL SHEATH. DURING THE DEVICE REMOVAL, THE DISTAL WIRE BROKE OFF AND UNDER FLUOROSCOPY THE CAPTURE WIRE SEGMENT CONTAINING THE STENT AND FILTER COULD BE VISUALIZED AS HAVING MIGRATED TO THE FEMORAL ARTERY BIFURCATION. THE PHYSICIAN IMMEDIATELY CALLED FOR VASCULAR INTERVENTIONAL CARDIOLOGIST AND A VASCULAR SURGEON TO THE CATH LAB PROCEDURE ROOM. THE PHYSICIAN WAS ABLE T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7217994 ↗
• InjuryDec 18, 2017Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING A SPIDER FX EMBOLIC PROTECTION DEVICE WHILE TREATING A MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT CORONARY ARTERY LESION EXHIBITING CHRONIC TOTAL OCCLUSION. THE VESSEL WAS NOT PRE-DILATED. A NON-MDT GUIDEWIRE WAS USED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. IT WAS REPORTED THAT ONCE THE FILTER WAS POSITIONED, THE PHYSICIAN WAS UNABLE TO OPEN THE BLOCKAGE. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO RECAPTURE THE FILTER, THE TIP DETACHED. THE DETACHED TIP WAS LEFT IN THE PATIENT. THE PHYSICIAN COMMENTED THAT THE TIP WOULD LODGE IN THE BRANCH. THE SURGERY WAS TURNED DOWN. NO OTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7127744 ↗
• InjuryDec 15, 2017Break; Migration or Expulsion of Device; Difficult to Remove

  THE PATIENT WENT TO THE CARDIAC CATH LAB FOR PLANNED RIGHT AND LEFT HEART CATHETERIZATION DUE TO HER SUB-TOTAL OCCLUSION OF HER RIGHT CORONARY ARTERY. A STENT HAD INITIALLY BEEN PARTIALLY DEPLOYED TO THE RIGHT CORONARY ARTERY WITH A SPIDERFX WIRE FILTER DEVICE FOR DISTAL EMBOLIC PROTECTION, GIVEN THE LARGE THROMBUS BURDEN AT RISK OF EMBOLIZATION. DUE TO DIFFICULTY PASSING POST-DILATATION BALLOONS FOR FINAL STENT EXPANSION, A DECISION WAS MADE TO PROCEED TO REMOVE THE SPIDERFX WIRE FILTER. THE CAPTURE SHEATH OF THE FILTER SPIDERFX WIRE BECAME CAUGHT ON THE PROXIMAL EDGE OF THE STENT AND THEN THE STENT, FILTER WIRE AND CAPTURE SHEATH WERE REMOVED FROM THE CORONARY ARTERY. THE CAPTURE SHEATH WAS THEN REMOVED FROM THE BODY. HOWEVER, THE PROCEDURALIST WAS UNABLE TO REMOVE THE STENT-FILTER COMBINATION THROUGH THE FEMORAL SHEATH. DURING THE DEVICE REMOVAL, THE DISTAL WIRE BROKE OFF AND UNDER FLUOROSCOPY THE CAPTURE WIRE SEGMENT CONTAINING THE STENT AND FILTER COULD BE VISUALIZED AS HAVING MIGRATED TO THE COMMON FEMORAL ARTERY BIFURCATION. THE PROCEDURALIST IMMEDIATELY CALLED FOR VASCULAR INTERVENTIONAL CARDIOLOGIST AND A VASCULAR SURGEON TO THE CATH LAB PROCEDURE ROOM. THE PROCEDURALIST W

  Patient problems: No Code Available

  MAUDE report 7120527 ↗