ViperWire Advance FlexTip VPR-GW-FLEX18Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10852528005725), received between Jul 30, 2020 and Sep 17, 2026 — classified as 15 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Material Separation; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808469 ↗
• MalfunctionOct 17, 2025Difficult to Remove; Device Damaged by Another Device; Device-Device Incompatibility; Difficult to Remove; Device Damaged by Another Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON FEMORAL ARTERY (CFA) WITH HEAVY CALCIFICATION AND THE SUPERFICIAL FEMORAL ARTERY (SFA). THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS DEPLOYED WITH A VIPERWIRE GUIDE WIRE AND USED IN THE PROCEDURE. UPON RETRIEVAL, THE FILTER WAS ABLE TO BE COLLAPSED BUT ONLY HALFWAY DUE TO TOO MUCH DEBRIS AND THE WIRE, CATHETER AND FILTER COULD NOT BE PULLED IN THE 6FRENCH (F) SHEATH. FORWARD FORCE ON THE CATHETER WAS APPLIED. THE WIRE WAS PULLED BACKWARDS AND REMOVED BUT THE FILTER WAS SHEARED OFF. A PORTION OF THE FILTER WAS REMOVED BUT THE DISTAL TIP SNAPPED OFF DURING RETRIEVAL. ATTEMPTED TO ASPIRATE THE TIP BUT UNSUCCESSFUL. FLUOROSCOPY SHOWED THE TIP STARTED TRAVELING AND LODGED IN THE ANTERIOR TIBIAL (AT). THE PHYSICIAN WAS ABLE TO WIRE THE AT AND A NON-ABBOTT STENT WAS IMPLANTED TO EMBED THE SEPARATED TIP AND FILTER ON THE WALL OF THE VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327217 ↗
• InjuryAug 8, 2025Unintended System Motion; Material Separation; Device-Device Incompatibility; Unintended System Motion; Material Separation; Device-Device Incompatibility

  OA: IT WAS REPORTED AN ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A POPLITEAL ARTERY, FOLLOWED BY A LEFT SUPERFICIAL FEMORAL ARTERY (LSFA) AND A TIBIOPERONEAL TRUNK (TPT) ARTERY. AS THE OAD WAS BEING BACKED OUT TO TREAT ANOTHER LESION, THE OAD PULLED THE VIPERWIRE GUIDE WIRE, WHICH DISLODGED THE NAV 6 FILTER. IT WAS INDICATED THE OAD PULLING THE WIRE OUT OF POSITION WAS DUE TO IMPROPER WIRE-PINNING TECHNIQUE. THE RETRIEVAL CATHETER WAS LOADED ON THE GUIDE WIRE BUT WAS UNABLE TO BE ADVANCED. THE VIPERWIRE TIP FRACTURED AND LODGED WITHIN THE NAV 6 FILTER. THE FILTER WAS PULLED INTO THE SHEATH. A SHEATH SWAP WAS PERFORMED, BUT THE FRACTURED COMPONENT REMAINED IN-VIVO, IN AN OCCLUDED VESSEL. A DRUG-COATED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION. THE PHYSICIAN HAD NO CONCERNS ABOUT LONG TERM CONSEQUENCES FOR THE PATIENT. IN THE PHYSICIAN'S OPINION, THE COMPONENT MAY HAVE GOTTEN STUCK IN THE VESSEL LEADING TO THE FRACTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22751515 ↗
• InjuryMay 22, 2025Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Device-Device Incompatibility; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Device-Device Incompatibility

  IT WAS REPORTED A 2.0 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER TREATMENT, IT WAS OBSERVED THE VIPERWIRE GUIDE WIRE WAS KINKED PROXIMAL TO THE OAD HANDLE. THIS MADE IT DIFFICULT TO REMOVE THE OAD FROM THE GUIDE WIRE. THE ENTIRE SYSTEM, INCLUDING A NAV 6 FILTER, WAS REMOVED TOGETHER. UPON REMOVAL OF THE SYSTEM, THE PHYSICIAN NOTICED THE GUIDE WIRE FULL COIL WAS DETACHED AND IN THE PATIENT'S POSTERIOR TIBIAL ARTERY (PT). IT WAS UNCLEAR WHAT LED TO THE FRACTURE. THE PHYSICIAN ENTRAPPED THE FRACTURED COMPONENT WITH A ESPRIT BTK SCAFFOLD 3.0 X 38 THEN POST DILATED WITH A 3.5 X 20 NC BALLOON. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22072019 ↗
• InjuryApr 21, 2025Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 190CM EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED THROUGH RESISTANCE; HOWEVER WAS NOTED TO FAIL TO DEPLOY THE FILTRATION ELEMENT AND DURING REMOVAL RESISTANCE WAS FELT AND THE DISTAL END OF THE .018 VIPERWIRE GUIDE WIRE WAS NOTED TO SEPARATE NEAR THE DISTAL END OF THE 6F SHEATH AFTER FORCE WAS APPLIED. AFTER THE EPS WAS COMPLETELY REMOVED AN ATTEMPT TO SNARE THE SEPARATED VIPERWIRE WAS MADE; HOWEVER WAS NOTED TO BE UNSUCCESSFUL. THEREFORE THE SEPARATE PIECE WAS SURGICALLY REMOVED ON THE SAME DAY. IT WAS UNKNOWN HOW THE FRACTURE OCCURRED AS THE GUIDE WIRE WAS FRACTURED BY THE TIME FORCE WAS APPLIED DURING REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECT NOR CLINICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21875444 ↗
• InjuryMar 21, 2025Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE INTERVENTION WAS TO OPEN THE OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 7FR ACCESS IN THE RIGHT COMMON FEMORAL ARTERY (CFA) WITH CONTRALATERAL APPROACH TO THE LEFT CFA WAS PERFORMED. THE LESION WAS CROSSED WITH TWO NON-ABBOTT CATHETERS AND ONE OF THE NON-ABBOTT CATHETER WAS EXCHANGED FOR A .014/.018 VIPERWIRE ADVANCE GUIDEWIRE. A 7.2MM EMBOSHIELD NAV6 WAS DEPLOYED IN THE MID POPLITEAL ARTERY. A 1.5 SOLID DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO IN THE LEFT SFA, FOLLOWED BY PTA AND DCB. TWO LOW SPEED AND TWO MEDIUM SPEED TREATMENTS WERE PERFORMED.WHEN RETRIEVAL OF THE NAV6 OCCURRED, IT WAS IDENTIFIED THAT THE TIP OF THE VIPERWIRE HAD SEPARATED, WAS COILED IN A LOOP, AND REMAINED IN THE POPLITEAL ARTERY. AFTER MULTIPLE ATTEMPTS, RETRIEVAL OF THE WIRE TIP WAS ACHIEVED WITH A SNARE WITH THE USE OF A VIPERWIRE PERIPHERAL ADVANCE GUIDEWIRE. THERE WAS NO WIRE BIAS OR DIFFICULTY DELIVERING DEVICES. THE OAD DID NOT MAKE CONTACT WITH THE VIPERWIRE SPRING TIP, AS THERE WAS A NAV6 ON THE VIPERWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663553 ↗
• InjuryFeb 19, 2025Material Separation; Material Separation

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) AND A POPLITEAL ARTERY. THREE LOW SPEED, TWO MEDIUM SPEED, AND TWO HIGH SPEED TREATMENTS WERE PERFORMED. WHEN THE OAD WAS BEING REMOVED, THE VIPERWIRE GUIDE WIRE FRACTURED. ANGIOGRAPHIC IMAGING SHOWED THE DISTAL PORTION OF THE VIPERWIRE WAS STUCK IN THE PERONEAL ARTERY. A SNARE WAS USED TO RETRIEVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412836 ↗
• InjuryJan 9, 2025Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE, AND A NAV6 FILTER WERE USED TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED, SEVERELY STENOSED LESION IN THE RIGHT POPLITEAL. FOLLOWING SEVERAL TREATMENTS, THE NAV6 WAS ATTEMPTED TO BE REMOVED, HOWEVER, WAS UNABLE TO BE PULLED BACK INTO THE RETRIEVAL CATHETER POD. DURING REMOVAL OF ALL THE DEVICES, THE GUIDE WIRE FRACTURED. A PAIR OF HEMOSTATS WERE USED AS A SNARE TO REMOVE THE DEVICES SUCCESSFULLY. THE PATIENT WAS STABLE WITH NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118147 ↗
• InjuryNov 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT POSTERIOR TIBIAL ARTERY. IT WAS OBSERVED THE VIPERWIRE ADVANCE GUIDEWIRE WITH FLEXTIP FRACTURED AFTER SIX LOW SPEED, SIX MEDIUM SPEED, AND SIX HIGH SPEED TREATMENTS. TEN CENTIMETERS OF THE FRACTURED COMPONENT WAS LEFT IN THE PERONEAL ARTERY. RETRIEVAL ATTEMPTS WERE UNSUCCESSFUL, THEREFORE, FOUR XIENCE STENTS WERE PLACED OVER THE FRACTURED COMPONENT TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20762478 ↗
• MalfunctionSep 23, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  A VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP WAS USED FOR TREATMENT OF A HEAVILY CALCIFIED, CHRONIC TOTAL OCCLUSION (CTO), 5-6MM DIAMETER LESION IN SUPERFICIAL FEMORAL ARTERY (SFA) VIA RIGHT COMMON FEMORAL ARTERY (CFA). A 6FR 45CM GUIDING SHEATH WAS IN USE. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. AFTER FIVE TO SIX TREATMENTS OF THE TARGET LESION, THE ABBOTT NAV6 FILTER WAS CAPTURED. WHILE REMOVING THE FILTER HALFWAY THROUGH THE SHEATH A THREE-CM TIP OF THE .018-INCH VIPERWIRE FRACTURED. THE SHEATH WAS REMOVED WITH THE NAV6 FILTER AND THE TIP OF THE VIPERWIRE IN THE SHEATH. AFTER SHEATH REMOVAL MANUAL PRESSURE WAS APPLIED ON THE ACCESS SITE TO OBTAIN HEMOSTASIS. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280917 ↗
• InjuryJun 14, 2023Material Separation; Material Separation

  THE VIPERWIRE ADVANCE GUIDE WIRE TIP FRACTURED. THE FRACTURED COMPONENT WAS RETRIEVED. A NEW VIPERWIRE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17125697 ↗
• InjuryMar 31, 2023Material Separation; Material Separation

  FOLLOWING AN ATHERECTOMY PROCEDURE, THE VIPERWIRE ADVANCE GUIDE WIRE WAS OBSERVED TO BE KINKED ON THE PROXIMAL END. DURING FINAL ANGIOGRAPHY, SLOW FLOW WAS OBSERVED. AFTER PANNING THE X-RAY DOWN, THE TIP OF THE VIPERWIRE WAS STILL IN THE PATIENT, AS IT MIGRATED FROM THE DISTAL PERONEAL TO THE PROXIMAL PERONEAL. A SNARE WAS USED TO CAPTURE THE FRACTURE WIRE TIP WITHOUT ANY OTHER ADVERSE EVENTS. THE PATIENT WAS TREATED WITH A DRUG-COATED BALLOON. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16656397 ↗
• InjuryOct 26, 2022Material Separation; Material Separation

  A VIPERWIRE ADVANCE GUIDE WIRE WAS ADVANCED IN THE ANTERIOR TIBIAL ARTERY (AT) WITH AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEMIS FILTER IN PLACE IN THE DISTAL POPLITEAL ARTERY. A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE OAD, FILTER, AND VIPERWIRE WERE REMOVED. THE PHYSICIAN RE-WIRED THE AT TO TREAT THE DISTAL POPLITEAL ARTERY, BUT THERE WAS INSUFFICIENT WIRE TO PERFORM TREATMENT. TWO LOW SPEED, ONE MEDIUM SPEED, AND ONE HIGH SPEED TREATMENT WERE PERFORMED PRIOR TO THE VIPERWIRE SPRING TIP FRACTURING. THE VIPERWIRE WAS REMOVED AND THE SPRING TIP OF BROKE OFF. THE SPRING TIP WAS SUCCESSFULLY SNARED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15674135 ↗
• InjuryMay 21, 2022Material Separation; Material Separation

  WHEN ATTEMPTING TO REMOVE THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE VIPERWIRE ADVANCE GUIDE WIRE FRACTURED. THE OAD WAS REMOVED, BUT THE FRAGMENT REMAINED IN VIVO WITH A FILTER DEPLOYED OVER THE FRAGMENT. THE FILTER DETACHED FROM THE WIRE WHILE ATTEMPTING TO SNARE THE FRAGMENT. THE FRAGMENT AND FILTER WERE SUCCESSFULLY RETRIEVED, AND NOTHING REMAINED IN VIVO.

  Patient problems: Foreign Body In Patient

  MAUDE report 14465934 ↗
• MalfunctionMay 6, 2022Break

  THE VIPER WIRE FOR THE CSI DEVICE SHEARED OFF ALONG WITH THE DISTAL PROTECTION DEVICE. THE VIPERWIRE WAS RETRIEVED WITH A ENSNARE AND THE DISTAL PROTECTION DEVICE WAS RETRIEVED WITH THE BSC RADIAL JAW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309591 ↗
• MalfunctionApr 22, 2022Material Separation; Material Separation

  A VIPERWIRE GUIDEWIRE AND ORBITAL ATHERECTOMY DEVICE (OAD) WERE USED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY VIA FEMORAL ANTEGRADE APPROACH. THE VESSEL WAS NOT TORTUOUS, AND THE DIAMETER WSA 2.5MM. THE LESION WAS A CHRONIC TOTAL OCCLUSION. THE WIRE FRACTURED DURING WIRE EXCHANGE PRIOR TO ATHERECTOMY. THE PHYSICIAN WAS ABLE TO REMOVE THE WIRE TIP WITH USE OF THE CATHETER. A 4FR SHEATH WAS ADVANCED OVER THE WIRE FRAGMENT AND CATHETER, AND THE SHEATH WAS RETRACTED. TREATMENT WAS COMPLETED THEREAFTER.

  Patient problems: Foreign Body In Patient

  MAUDE report 14187395 ↗
• InjuryApr 1, 2022Material Separation; Material Separation

  A VIPERWIRE GUIDE WIRE WAS ADVANCED PAST THE POPLITEAL ARTERY, AND A NON-CSI FILTER WAS DEPLOYED OVER THE WIRE. ATHERECTOMY WAS PERFORMED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WHICH WAS THEN REMOVED. THE LESION WAS APPROXIMATELY 100MM IN LENGTH, HEAVILY CALCIFIED, AND EXHIBITED AT LEAST 4 MM OF CALCIUM. AN ANGIOPLASTY BALLOON WAS PLACED AND INFLATED TO NOMINAL PRESSURE AND REMOVED. A DRUG COATED BALLOON (DCB) WAS THEN INSERTED OVER THE WIRE, INFLATED FOR THREE MINUTES, AND REMOVED. A STENT WAS THEN DEPLOYED IN THE POPLITEAL VESSEL. SIMULTANEOUSLY, WHILE THE STENT WAS BEING DEPLOYED, THE FILTER PULLED BACK, THOUGH BOTH APPEARED INTACT. A NON-CSI BALLOON, THAT WAS NOT INFLATED, WAS THEN USED TO ATTEMPT TO REPOSITION THE FILTER DISTAL TO THE STENT. THE TIP OF THE VIPERWIRE WAS THEN OBSERVED TO HAVE FRACTURED. AN ATTEMPT WAS MADE TO RETRIEVE THE VIPERWIRE TIP WITH THE FILTER. THE FILTER BASKET WAS RETRIEVED, BUT THE FRAGMENT REMAINED IN VIVO. A SNARE WAS THEN USED TO CAPTURE THE FRAGMENT FROM THE TIBIOPERONEAL (TP) TRUNK.

  Patient problems: Foreign Body In Patient

  MAUDE report 13978195 ↗
• InjuryAug 19, 2020Material Separation; Material Separation

  A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS TREATED WITH A PERIPHERAL ORBITAL ATHERECTOMY DEVICE USED OVER A VIPERWIRE GUIDE WIRE WITH A NAV6 FILTER. AFTER TREATMENT WAS COMPLETED, THE FILTER WAS RETRIEVED AND THE VIPERWIRE WAS NOTED TO HAVE FRACTURED. THE FRAGMENT WAS IN A SIDE BRANCH OF THE POSTERIOR TIBIAL ARTERY. ATTEMPTS TO REMOVE THE FRAGMENT WITH A SNARE WERE MADE, HOWEVER THE SNARE WAS UNABLE TO TRAVERSE THE ANGLE INTO THE SIDE BRANCH. MULTIPLE WIRES WERE THEN INSERTED AND USED TO RETRIEVE THE WIRE FRAGMENT. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10425995 ↗
• InjuryJul 30, 2020Material Separation; Material Separation

  DURING A PROCEDURE, A 1.5 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE GUIDE WIRE WERE SELECTED FOR USE FOR A MID TO DISTAL PERONEAL LESION. THE VESSEL WAS APPROXIMATELY TWO (2) MILLIMETERS IN DIAMETER. THE LESION WAS TREATED WITH FIVE PASSES ON LOW SPEED. THE OAD WAS REMOVED. WHEN THE BALLOON WAS PLACED FOR ANGIOPLASTY, IT WAS OBSERVED THAT THE GUIDE WIRE SPRING TIP HAD FRACTURED. THE FRAGMENT WAS APPROXIMATELY TWO (2) CENTIMETERS LONG. AS THE FRAGMENT WAS DISTAL AND THE OUTFLOW WAS GOOD, THE PHYSICIAN ELECTED TO ABANDON THE FRAGMENT AND DID NOT ATTEMPT TO SNARE IT. ADDITIONAL ANGIOPLASTY OF THE LESION WAS PERFORMED. THE PHYSICIAN STATED THE VESSELS IN THE LOWER LEG WERE IMPROVED COMPARED TO THE START OF THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING THE PROCEDURE FOR A PREVIOUSLY PLANNED AMPUTATION OF THE GREAT TOE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10347279 ↗