ViperWire Advance FlexTipRecalls & reported problems across all models

We found 4 models of ViperWire Advance FlexTip by Cardiovascular Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 188 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2015 and Sep 17, 2026 — classified as 170 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (169 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 ViperWire Advance FlexTip problems

ViperWire Advance FlexTip models

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

• ViperWire Advance FlexTip VPR-GW-FT14

  Catheter, Peripheral, Atherectomy
  82 reports
• ViperWire Advance FlexTip VPR-GW-FLEX14

  Catheter, Peripheral, Atherectomy
  76 reports
• ViperWire Advance FlexTip VPR-GW-FLEX18

  Catheter, Peripheral, Atherectomy
  19 reports
• ViperWire Advance FlexTip VPR-GW-FT18

  Catheter, Peripheral, Atherectomy
  11 reports

Recent ViperWire Advance FlexTip adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryAug 13, 2026Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  Patient problems: Foreign Body In Patient

  MAUDE report 50244494 ↗
• InjuryMar 12, 2026Material Separation

  IT WAS REPORTED A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE OAD CONTACTED THE VIPERWIRE SPRING TIP LEADING TO A FRACTURE. THE FRACTURED COMPONENT WAS RETRIEVED WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION. IT WAS INDICATED THE OAD CONTACTING THE VIPERWIRE SPRING TIP WAS DUE TO USE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582804 ↗
• InjuryFeb 5, 2026Material Separation

  IT WAS REPORTED THAT ABBOTT COMMAND WIRE WAS DURING PROCEDURE PAST SUPERFICIAL FEMORAL ARTERY (SFA) LESION AND ORBITAL ATHERECTOMY WAS PERFORMED WITHOUT ISSUES. THREE TREATMENTS ON LOW, MEDIUM AND HIGH SPEEDS WERE PERFORMED. IT WAS BIDIRECTION TREATMENT. ARMADA18 BALLOON WAS LOADED ONTO THE VIPERWIRE PERIPHERAL GUIDEWIRE FOR POST DILATION AND UPON ARMADA BALLOON BEING DEFLATED, IT WAS NOTED THE WIRE WAS MISSING AND TRAVELED DOWN THE LEG A SMALL WAY. THE BROKEN VIPERWIRE GUIDEWIRE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT¿S LEG BY TRAPPING IT WITH A TREK CORONARY BALLOON AND REMOVING THE WHOLE WIRE, BALLOON, AND SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS. IT WAS NOTED THAT THERE WAS NO WIRE BIAS AND THERE IS NO INDICATION ON HOW THE FRACTURE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272640 ↗
• MalfunctionJan 29, 2026Break; Difficult to Remove

  IT WAS REPORTED THAT A VIPERWIRE PERIPHERAL FLEXTIP GUIDEWIRE WAS USED WITH A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) TO TREAT CALCIFICATION DIFFUSED DISEASE THROUGHOUT THE POSTERIOR TIBIAL (PT) ARTERY TO THE DORSALIS PEDIS (DP). EIGHT TREATMENTS WERE PERFORMED IN THE PT ON LOW SPEED, THE VIPERWIRE GUIDEWIRE CROSSED THE ANKLE AND THE OAD DID NOT CROSS THE ANKLE BY PHYSICIAN'S CHOICE. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE OAD. THE PHYSICIAN PURPOSELY STAYED AWAY FROM THAT AREA DUE TO ANATOMY AND TO KEEP PLENTY OF SPACE AWAY FROM WIRE TIP. THE VESSEL WAS BALLOONED AND THERE WAS DIFFICULTY DURING REMOVAL OF THE GUIDEWIRE FROM THE VESSEL AFTER TREATMENT. THE GUIDEWIRE WAS FORCEFULLY REMOVED AND DID NOT FRACTURE, HOWEVER, THE SPRING TIP WAS FRAYED. IT WAS NOTED THAT OAD AND GUIDEWIRE DID NOT MAKE CONTACT DURING THE PROCEDURE. THE PHYSICIAN SUSPECTED THE ISSUE WAS DUE TO PATIENT ANATOMY. IT WAS NOTED THAT THE ISSUE WITH THE GUIDEWIRE HAPPENED IN THE FOOT WHERE THERE WAS NO PRIOR TREATMENT WITH OAD OR ANY BALLOONING. THE PATIENT WAS STABLE. INITIAL ANALYSIS OF THE RETURNED VIPERWIRE PERIPHERAL GUIDEWIRE INDICATED THAT THE SPRING TIP STRAIN RELIEF WAS UNRAVELED BUT NOT DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211821 ↗
• InjuryDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT POST ATHERECTOMY PROCEDURE, DURING REMOVAL, THE VIPERWIRE PERIPHERAL GUIDEWIRE FRACTURED AND THE TIP OF THE GUIDEWIRE REMAINED IN-VIVO. A SNARE WAS USED TO RETRIEVE THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871838 ↗
• InjuryDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER REMOVING THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE TIP OF THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP REMAINED IN THE PATIENT. SNARE WAS USED TO REMOVE THE TIP OF THE VIPERWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23867125 ↗
• InjuryDec 8, 2025Entrapment of Device; Unintended System Motion; Material Separation; Entrapment of Device; Unintended System Motion; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT LESION IN CALCIFIED, HIGHLY TORTUOUS, 85% STENOSED DISTAL DORSALIS PEDIS ARTERY (DP), THE 1.25 MICRO DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) SHUT OFF DURING FIRST RUN. THE VESSEL DIAMETER WAS 2.00MM. THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP WAS EXCHANGED FROM A NON-ABBOTT WIRE. DURING REMOVAL, IT WAS NOTED THAT THE OAD BECAME ENTANGLED IN THE DISSECTION FLAP. THERE WAS NO DISSECTION BEFORE THE PROCEDURE. THE DISSECTION WAS NOT SEEN ANGIOGRAPHICALLY BUT THE PHYSICIAN THOUGHT IT WAS A SMALL FLAP THAT THE CROWN GOT STUCK ON. THE OAD AND THE VIPERWIRE COULD NOT BE REMOVED DUE TO THE VIPERWIRE BEING FRACTURED AND STUCK IN THE VESSEL. A CUT DOWN PROCEDURE WAS PERFORMED FOR REMOVAL, AND THE PHYSICIAN WAS ABLE TO REMOVE THE CROWN, BUT THE ENTIRE RADIOPAQUE SECTION OF THE VIPERWIRE TIP WAS LEFT IN THE LEG AS THERE WAS NO LONGER ACCESS TO THE VESSEL. WIRE ACCESS WAS LOST DUE TO THE VIPERWIRE BEING STUCK IN THE VESSEL DISTAL TO THE CROWN THAT WAS STUCK IN THE VESSEL WALL. THE VIPERWIRE RADIOPAQUE TIP WAS LEFT IN THE FOOT AND THE CUT DOWN TO REMOVE THE CROWN WAS SUTURED CLOSED. THE DISSECTION WAS N

  Patient problems: Foreign Body In Patient

  MAUDE report 23750456 ↗
• InjuryDec 5, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT A 1.25 SOLID DIAMONDBACK 360 PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF HEAVILY CALCIFIED, NON-TORTUOUS, CHRONIC TOTAL OCCLUSION (CTO) LESION IN RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH LEFT FEMORAL ARTERY UP-AND-OVER APPROACH. A 7FR SHEATH WAS IN USE. AN ABBOTT COMMAND GUIDE WIRE WAS INITIALLY ADVANCED TO THE LESION AS FAR AS IT CAN GO AND EXCHANGED FOR A VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP. THE VIPERWIRE GUIDEWIRE WAS THEN ADVANCED HALFWAY THROUGH THE SFA. THERE WAS NO WIRE BIAS. INITIAL TREATMENT WAS STARTED. THE PHYSICIAN WAS AWARE THEY WERE TOO CLOSE TO THE TIP OF THE VIPERWIRE GUIDEWIRE BUT CONTINUED ADVANCING AS CLOSE AS THEY COULD AS THIS WAS A LAST EFFORT TO PREVENT SURGERY. THIS RESULTED IN THE OAD CROWN COMING IN CONTACT WITH THE VIPERWIRE TIP CAUSING GUIDEWIRE FRACTURE. THE VIPERWIRE RADIOPAQUE TIP REMAINED IN THE RIGHT SFA WITHOUT FURTHER MEDICAL INTERVENTION SINCE THE PHYSICIAN BELIEVED NO DEVICE COULD GET THROUGH THE OCCLUSION. THE OAD AND THE VIPERWIRE WERE REMOVED. THE PROCEDURE WAS ABORTED. THE PATIENT WAS SCHEDULED FOR SURGICAL FEMORAL BYPASS. THE DATE OF THE PROCEDURE WAS UNKNOW

  Patient problems: Foreign Body In Patient

  MAUDE report 23730325 ↗
• InjuryNov 19, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT A 1.25 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND A VIPERWIRE PERIPHERAL GUIDEWIRE WERE USED TO TREAT THE PERONEAL ARTERY. THE VESSEL WAS PRIMARILY WIRED WITH THE VIPERWIRE GUIDEWIRE. APPROXIMATELY NINE TREATMENTS WERE PERFORMED ON LOW, MEDIUM, AND HIGH-SPEED. THE OAD MADE CONTACT WITH THE SPRING TIP, RESULTING IN A GUIDE WIRE FRACTURE. THE ENTIRE RADIOPAQUE TIP REMAINS IN VIVO. THERE WAS NO WIRE BIAS. AN ATTEMPT WAS MADE TO BALLOON THE FRAGMENT TO THE WALL BUT IMAGING DID NOT SHOW ANY MOVEMENT OF THE FRAGMENT. IN ADDITION, PERSISTENT SLOW FLOW WAS OBSERVED. NITROGLYCERIN WAS ADMINISTERED. THE PATIENT WAS STABLE. THE PHYSICIAN DID NOT HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES. ADDITIONAL INFORMATION WAS RECEIVED AND IN THE OPINION OF THE PHYSICIAN, THE VIPERWIRE GUIDEWIRE WAS THE CAUSE OF THE SLOW FLOW AND FLOW WAS RESTORED ON ITS OWN. THE PATIENT'S WOUNDS WERE HEALING.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 23597757 ↗
• InjuryNov 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 99% STENOSED, HEAVILY CALCIFIED, MILDLY TORTUOUS POPLITEAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 7FR SHEATH RIGHT GROIN ACCESS, A 1.5 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED WITH VIPERWIRE GUIDEWIRE. IT WAS NOTED THAT THERE WAS NO WIRE BIAS AND THE VESSEL WAS NOT PRIMARILY WIRED WITH VIPERWIRE GUIDEWIRE, IT WAS EXCHANGED. DURING REMOVAL OF THE CATHETER, THE GUIDEWIRE TIP BROKE OFF AS IT WAS STUCK ON CALCIUM. THE RADIO OPAQUE TIP OF THE WIRE ABOUT 3 CM IN LENGTH WAS SNARED. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485699 ↗
• 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 ↗
• InjurySep 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PERIPHERAL INTERVENTION OF THE LEFT LEG VIA RIGHT FEMORAL ARTERY & LEFT POSTERIOR TIBIAL (PT) PEDAL ACCESS, A VIPERWIRE PERIPHERAL GUIDEWIRE WAS ADVANCED DOWN INTO THE DISTAL PERONEAL ARTERY. THE 1.25 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS PLACED OVER THE VIPERWIRE GUIDEWIRE TO TREAT THE TIBIOPERONEAL (TP) TRUNK AND DOWN TO ABOUT THE MID-PERONEAL. AT SOME POINT BETWEEN CHECKING THE VIPERWIRE GUIDEWIRE TIP PLACEMENT AND THEN ACTUALLY STARTING THE TREATMENT, THE GUIDEWIRE WAS PULLED BACK AND THEN ADVANCED DEEP INTO A COLLATERAL. DURING FIRST TREATMENT, A SLACK IN THE VIPERWIRE GUIDEWIRE WAS NOTICED ON THE FLOUROSCOPY MONITOR. THE GUIDEWIRE FRACTURED AND THE OAD AUTOMATICALLY SHUT OFF. THE OAD WAS REMOVED, TWO GUIDEWIRE FRAGMENTS LEFT IN-VIVO. THE MAJORITY OF THE TIP OF THE VIPERWIRE GUIDEWIRE SPRING TIP WAS LODGED DEEP INTO A COLLATERAL OFF OF THE PERONEAL. A SMALL PIECE OF WIRE FRAGMENT WAS AT THE DISTAL TO THE TAKEOFF OF THE PERONEAL. MULTIPLE SNARES WERE USED TO TRY AND REMOVE THE FRAGMENTS BUT WERE UNSUCCESSFUL. AT THIS POINT IT WAS NOTICED THAT THE SMALL PROXIMAL FRAGMENT PIECE WAS MOSTLY OCCLUSIVE AND THERE WAS NO FLOW IN E

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 23028417 ↗
• 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 ↗
• InjuryJun 23, 2025Material Separation; Material Separation

  IT WAS REPORTED A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A HEAVILY CALCIFIED LESION IN RIGHT PROXIMAL ANTERIOR TIBIAL ARTERY (AT). AFTER TWO LOW SPEED TREATMENTS AND ONE MEDIUM SPEED TREATMENT, THE VIPERWIRE PERIPHERAL GUIDE WIRE FRACTURED IN HALF AND WAS SUCCESSFULLY SNARED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE PROCEDURE WAS DELAYED BY 30-40 MINS. THIS WAS NOT CONSIDERED CLINICALLY SIGNIFICANT DELAY. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE, 2.5X240 JADE BALLOON, AND NC TREK BALLOON TO OPEN UP AT. IT WAS UNKNOWN HOW THE GUIDE WIRE FRACTURE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309870 ↗

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