Wirion WRN-D6Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10850000491882), received between Apr 7, 2021 and Dec 7, 2021 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2021Material Separation; Material Separation

  A WIRION EMBOLIC PROTECTION SYSTEM FILTER WAS USED DURING ATHERECTOMY TREATMENT OF A HIGHLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE FILTER BASKET WAS NOT FULL FOLLOWING TREATMENT. DURING RETRIEVAL OF THE FILTER, ALL THREE INDICATORS APPEARED TO BE WITHIN THE RETRIEVAL CATHETER, HOWEVER A SMALL AMOUNT OF RESISTANCE WAS MET AND A PORTION OF THE FILTER BASKET DETACHED WHILE IT WAS BEING PULLED THROUGH THE SHEATH. THE FILTER FRAGMENT WAS STENTED TO THE VESSEL WALL. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE. PER THE OPINION OF THE PHYSICIAN, THE FILTER MAY HAVE BECOME CAUGHT ON THE EDGE OF THE SHEATH DURING REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12954774 ↗
• MalfunctionNov 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE WIRION FILTER WAS ADVANCED INTO THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD MULTIPLE LESIONS, AND THE FILTER COULD NOT BE ADVANCED ACROSS THE DISTAL LESION. THE LESION WAS PREDILATED WITH 3MM BALLOON, BUT THE FILTER STILL WOULD NOT CROSS THE LESION. THE FILTER WAS DEPLOYED FARTHER PROXIMAL THAN DESIRED. THE PROXIMAL LESION WAS TREATED WITH ATHERECTOMY WITHOUT ISSUE; THE ATHERECTOMY DEVICE DID NOT COME INTO CONTACT WITH THE FILTER. UPON RETRIEVAL OF THE FILTER, THE BASKET SHEARED OR BROKE OFF. THE PHYSICIAN SUSPECTED THE TORN PORTION WAS REMOVED DURING RETRIEVAL SINCE NO COMPONENTS WERE SEEN ON IMAGING IN VIVO, AND THERE WERE NO COMPONENTS EXTERNALIZED FROM THE RETRIEVAL CATHETER. A NON-CSI FILTER WAS USED TO CONTINUE THE PROCEDURE. THE REASON FOR THE INITIAL FILTER DAMAGE COULD NOT BE DETERMINED BY THE PHYSICIAN OR CSI FIELD STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851873 ↗
• MalfunctionNov 7, 2021Material Deformation; Material Deformation

  THE WIRION FILTER WAS DEPLOYED INTO THE DISTAL POPLITEAL AND MULTIPLE EXCHANGES WERE MADE OVER THE WIRE. THE FILTER WAS CONTINUOUSLY ADVANCED AND RETRACTED TO IT'S INTENDED LOCATION. DURING REMOVAL, IT WAS REVEALED THAT PART OF THE FILTER BASKET WAS EXPOSED. THERE WERE NO PATIENT ADVERSE EVENTS. DEVICE ANALYSIS IDENTIFIED THAT THE RETURNED FILTER FRAME WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758906 ↗
• MalfunctionOct 14, 2021Material Separation; Material Separation

  THE WIRION FILTER WAS DEPLOYED SUCCESSFULLY IN THE DISTAL POPLITEAL OVER A VIPERWIRE GUIDE WIRE. ATHERECTOMY AND ANGIOPLASTY WERE PERFORMED SUCCESSFULLY IN DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY. THE FILTER WAS RETRIEVED SUCCESSFULLY AFTER INTERVENTION. UPON RETRACTING THE RETRIEVAL CATHETER, THE DOCTOR FELT SOME RESISTANCE WITHIN THE SHEATH JUST PRIOR TO THE DEVICE EXITING. HE MANIPULATED THE RETRIEVAL CATHETER FORWARD AND ROTATED IT. HE WAS ABLE TO REMOVE IT FROM THE SHEATH, BUT THE DISTAL END OF THE FILTER REMAINED WITHIN THE SHEATH JUST AT THE PROXIMAL ACCESS POINT JUST PAST THE VALVE. THE PHYSICIAN SUCCESSFULLY REMOVED THE SHEATH, WHICH CONTAINED THE DISTAL END OF THE FILTER. HE BELIEVES PART OF THE FILTER BECAME EXPOSED WHILE COMING OUT OF THE SHEATH/VALVE AND GOT STUCK. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636612 ↗
• InjurySep 15, 2021Difficult to Remove; Difficult to Remove

  THE WIRION FILTER WOULD NOT RETRACT INTO THE RETRIEVAL CATHETER. TWO ADDITIONAL NON-CSI CATHETERS WERE INSERTED TO RETRIEVE THE FILTER BUT WERE UNSUCCESSFUL. THE 6FR SHEATH WAS EXCHANGED TO AN 8FR SHEATH WITH THE VIPERWIRE GUIDE WIRE EXTERNALIZED, AND AN ADDITIONAL NON-CSI GUIDE WIRE WAS INSERTED THROUGH THE SHEATH. LEAVING THE WIRE IN PLACE, THE SHEATH WAS RETRACTED WHILE MANUAL PRESSURE WAS HELD ON THE FEMORAL ARTERY, ALLOWING THE VIPERWIRE AND FILTER TO BE REMOVED. ANGIOGRAPHY WAS PERFORMED AND THE VESSEL WAS PATENT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475819 ↗
• InjurySep 7, 2021Difficult to Remove; Difficult to Remove

  DURING A CRITICAL LIMB ISCHEMIA PROCEDURE, PREVIOUSLY PLACED KISSING STENTS CREATED A TIGHT BIFURCATION. A BALLOON WAS USED TO PRETREAT TIGHT LESIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND OSTIAL SFA. THE WIRION EMBOLIC PROTECTION DEVICE WAS PREPARED AND ADVANCED INTO THE BODY. DUE TO THE ANATOMY OF THE LESION, THE FILTER WAS UNABLE TO ADVANCE PAST THE DISTAL LESION, AND WAS REMOVED UNDEPLOYED. ORBITAL ATHERECTOMY WAS PERFORMED THROUGH THE ENTIRE VESSEL ON LOW SPEED. A NEW FILTER WAS OPENED AND WAS STILL DIFFICULT TO DEPLOY PAST THE LESION. THE FILTER WAS EVENTUALLY ABLE TO ADVANCE PAST THE LESION. THE VESSEL WAS TREATED AGAIN WITH ORBITAL ATHERECTOMY AND BALLOON ANGIOPLASTY WITH A GOOD RESULT. UPON REMOVAL ATTEMPTS, THE FILTER WAS UNABLE TO BE REACHED WITH THE RETRIEVAL CATHETER. A NON-CSI CATHETER WAS INSERTED AND ALL DEVICES WERE REMOVED TOGETHER WITH NO PATIENT COMPLICATIONS. PARTICULATE WAS OBSERVED IN THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436484 ↗
• InjuryAug 30, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  THE RETRIEVAL CATHETER OF THE WIRION EMBOLIC PROTECTION SYSTEM WOULD NOT CAPTURE THE FILTER DUE TO THE FILTER BEING FULL. A CATHETER WAS INSERTED IN AN ATTEMPT TO RETRIEVE THE FILTER, AND WHEN THE PHYSICIAN PULLED HARD THE TIP OF THE FILTER BECAME DETACHED. A STENT WAS PLACED OVER THE FILTER FRAGMENT AND IT REMAINED IN THE PATIENT. AT THE END OF THE PROCEDURE, IMAGING WAS PERFORMED AND THERE WAS GOOD FLOW. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12384403 ↗
• InjuryAug 30, 2021Unintended System Motion; Unintended System Motion

  A WIRION EMBOLIC PROTECTION DEVICE WAS SELECTED FOR USE DURING TREATMENT OF A MODERATELY CALCIFIED, 70% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE FILTER WAS DEPLOYED IN THE POPLITEAL ARTERY. LASER ATHERECTOMY WAS PERFORMED, AND EMBOLIZATION OF LESION DEBRIS OCCURRED. THE FILTER HAD MOVED 5-10MM DURING TREATMENT OF THE SFA LESION, AND THE EMBOLI WAS OBSERVED IN THE DISTAL POSTERIOR TIBIAL ARTERY. IN THE OPINION OF THE PHYSICIAN, THE FILTER MOVEMENT CONTRIBUTED TO THE DISTAL EMBOLIZATION. THE EMBOLIZATION WAS TREATED WITH BALLOON ANGIOPLASTY, AND THE PATIENT WAS COMFORTABLE WITH SLIGHT ANKLE PAIN FOLLOWING THE PROCEDURE. THE ANKLE PAIN RESOLVED, AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Embolism/Embolus

  MAUDE report 12384057 ↗
• InjuryAug 10, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  DURING RETRIEVAL OF THE WIRION EMBOLIC PROTECTION SYSTEM FILTER, IT WOULD NOT FULLY CAPTURE INSIDE OF THE RETRIEVAL CATHETER, AND THEREFORE WOULD NOT COME OUT OF THE 6FR SHEATH. THE PHYSICIAN PULLED ON THE DEVICE AND THE FILTER BROKE IN HALF. POPLITEAL ACCESS WAS OBTAINED AND THE FILTER FRAGMENT WAS SNARED FROM BELOW. THE PROCEDURE WAS COMPLETE AND ANGIOGRAPHY SHOWED NORMAL FLOW. THE PATIENT WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12301188 ↗
• InjuryAug 4, 2021Difficult to Remove

  DURING THE REMOVAL PROCESS OF THE WIRION EMBOLIC DEVICE FILTER, THE RETRIEVAL CATHETER WAS UNABLE TO RETRIEVE THE FILTER DEVICE. A 6 FRENCH GUIDE CATHETER WAS INSERTED TO RETRIEVE THE FILTER, AND UPON REMOVAL IT WAS OBSERVED THAT THE FILTER LOCKING MECHANISM WAS PROTRUDING OUT OF THE PROXIMAL MARKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274529 ↗
• InjuryJul 8, 2021Material Separation; Material Separation

  FOLLOWING SUCCESSFUL USE IN THE DISTAL POPLITEAL ARTERY, THE WIRION FILTER WAS CAPTURED AND REMOVED. THE USER HAD LEFT GROIN ACCESS WITH CONTRALATERAL APPROACH; RIGHT SIDE PERIPHERAL VASCULAR INTERVENTION OF THE SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY HAD BEEN PERFORMED. DURING REMOVAL, THE 6FR FILTER WAS DIFFICULT TO REMOVE THROUGH THE 6FR SHEATH. THE USER PULLED THE FILTER FORCEFULLY THROUGH THE SHEATH, AND IT BECAME STUCK. THE COMPONENTS WERE REMOVED TOGETHER. THE DISTAL MARKER AND A SMALL PART OF FILTER FRACTURED AND WAS LIKELY LEFT IN VIVO. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12139218 ↗
• MalfunctionApr 21, 2021Material Separation; Material Separation

  THE WIRION FILTER BECAME STUCK ON A STENT DURING TREATMENT OF A SEVERELY CALCIFIED LESION IN THE DISTAL POPLITEAL ARTERY VIA FEMORAL ACCESS. THE VESSEL WAS MILDLY TORTUOUS, AND THE VESSEL DIAMETER AT THE FILTER LOCATION WAS 5.2 MM. THE FILTER DEPLOYED AS INTENDED, BUT IT COULD NOT BE FULLY CAPTURED WITH THE RETRIEVAL DEVICE. DAMAGE TO THE FILTER WAS NOTED UPON REMOVAL FROM THE PATIENT; IT APPEARED TO BE FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699937 ↗
• InjuryApr 7, 2021Material Separation; Material Separation

  THE WIRION FILTER WAS DEPLOYED PER THE IFU WITH NO ISSUES NOTED. ATHERECTOMY AND BALLOON ANGIOPLASTY WERE PERFORMED AND IT WAS NOTED THAT THE BALLOON WAS DIFFICULT TO REMOVE OVER THE WIRE. A GUIDE WIRE CONTROL DEVICE WAS USED DURING THE PROCEDURE. THE FILTER RETRIEVAL DEVICE WAS INSERTED AND AN ATTEMPT TO RETRIEVE THE FILTER WAS MADE. THE FILTER WAS CAPTURED AND RESISTANCE WAS FELT WHEN ATTEMPTING TO REMOVE THE WIRE AND FILTER TOGETHER. THE PHYSICIAN PULLED BACK, AND THE RESISTANCE ABRUPTLY RELEASED. THE FILTER SEPARATED INTO TWO HALVES AND WAS VISUALIZED VIA FLUOROSCOPY. THE RETRIEVAL CATHETER, GUIDE WIRE AND UPPER PORTION OF THE FILTER WERE REMOVED FROM THE PATIENT. THE LOWER PORTION OF THE FILTER WAS LOCATED AT THE ORIGIN OF THE POSTERIOR TIBIAL ARTERY AND A MICRO SNARE WAS USED TO SUCCESSFULLY REMOVE IT FROM THE PATIENT. THE FINAL ANGIOGRAM SHOWED NO VESSEL ISSUES AT THE COMPLETION OF THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11626977 ↗