ViperWire, AdvanceRecalls & reported problems across all models

We found 2 models of ViperWire, Advance by Cardiovascular Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2016 and Apr 9, 2026 — classified as 41 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (41 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

ViperWire, Advance recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 13, 2016Terminated

   The pouch label was missing the use by date (UBD) of 2018-04.

   Z-2051-2016 · Root cause: Process control · Recall details · FDA record ↗

Most reported ViperWire, Advance problems

ViperWire, Advance models

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

• ViperWire, Advance VPR-GW-17

  Catheter, Peripheral, Atherectomy
  1 recall7 reports
• ViperWire, Advance VPR-GW-14

  Catheter, Peripheral, Atherectomy
  48 reports

Recent ViperWire, Advance adverse event reports

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

• MalfunctionApr 9, 2026Difficult to Remove

  IT WAS REPORTED THAT THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). A 6 X 45 SHEATH WAS IN USE. TREATMENTS WERE PERFORMED ON LOW AND MEDIUM SPEEDS. DURING THE HIGH-SPEED TREATMENT, THE OAD STALLED WHEN BEING PULLED BACK. THE OAD BECAME STUCK ON THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE. THE OAD AND VIPERWIRE WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE DRIVESHAFT OR VIPERWIRE. THE PATIENT WAS STABLE. IT WAS UNKNOWN IF THE ISSUE WAS WITH THE OAD OR VIPERWIRE. THERE WAS NO CLEAR INDICATION AS TO WHY THE OAD STALLED BUT THE TECHNICIAN STATED THAT THE PHYSICIAN DOES NOT HAVE X-RAY ON WHILE SPINNING AND MAY HAVE RUN OVER THE DISTAL VIPERWIRE TIP. DURING DEVICE ANALYSIS, A GUIDE WIRE FRACTURE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830921 ↗
• InjuryFeb 23, 2026Entrapment of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, NON-TORTUOUS, 80% STENOSED RIGHT PERONEAL ARTERY AND MODERATELY CALCIFIED, NON-TORTUOUS, 95% STENOSED ANTERIOR TIBIAL ARTERY (AT). A 5 FR NON-ABBOTT SHEATH WAS IN USE. A LESION IN THE PERONEAL HAS BEEN SUCCESSFULLY TREATED WITH THE OAD. THE PHYSICIAN PLANNED TO TREAT THE AT, BUT THE X-RAY MACHINE WENT DOWN. THE X-RAY WAS REBOOTED. ANGIOGRAPHIC IMAGES REVEALED THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WAS BENT IN MULTIPLE PLACES. IT WAS UNKNOWN WHAT LED TO THE VIPERWIRE DAMAGE. THE VIPERWIRE WAS SO BENT THEY COULD NOT GET IT BACK THROUGH THE SHEATH TO REMOVE IT. ANOTHER UNSPECIFIED WIRE WAS USED AND WITHDREW THE SHEATH AND VIPERWIRE TOGETHER BUT AS IT WAS COMING OUT OF THE BODY THE VIPERWIRE COULD NOT GET THROUGH AND GOT CAUGHT IN THE COMMON FEMORAL ARTERY (CFA) ARTERIAL WALL. THE SHEATH WAS REMOVED. A 5FR NON-ABBOTT DILATOR WAS USED TO REMOVE THE VIPERWIRE; THE STIFFNESS OF THE DILATOR HELPED STRAIGHTEN THE KINK TO ALLOW REMOVAL. A SECOND VIPERWIRE WAS INSERTED TO CONTINUE TREATMENT, BUT THE X-RAY MACHINE DIED AGAIN. THE PROCEDURE WAS ABORTED DUE TO THE X-RAY FAILING CONTINUOUSLY. THE PATIENT WAS STABLE. IT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24421720 ↗
• InjurySep 8, 2025Material Separation; Material Separation

  IT WAS REPORTED A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A TIBIOPERONEAL TRUNK (TP), POPLITEAL ARTERY, AND MID SUPERFICIAL FEMORAL ARTERY (SFA). AFTER FOUR TREATMENTS, THE PATIENT LIFTED THEIR LEG AND FLEXED THEIR HIP, RESULTING IN VIPERWIRE GUIDE WIRE WIRE BIAS. THE OAD WAS POWERED OFF. THE OAD WAS BEING REMOVED WITH GREAT RESISTANCE, THUS THE PHYSICIAN DECIDED TO REMOVE THE OAD AND VIPERWIRE TOGETHER. EX-VIVO IT WAS DETERMINED THE VIPERWIRE FRACTURED AND 80 CENTIMETERS REMAINED IN THE SFA AND MIGRATED TO THE PERONEAL ARTERY. THE FRACTURED COMPONENT WAS ABLE TO BE RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION. THE CAUSE OF THE FRACTURE WAS DETERMINED TO BE DUE TO THE PATIENT MOVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992186 ↗
• InjuryJun 11, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND .014 VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WERE USED FOR TREATMENT OF SEVERELY CALCIFIED, NON-TORTUOUS, 90% STENOSED LESION IN LEFT DISTAL SUPERFICIAL ARTERY (SFA) TO POPLITEAL ARTERY THROUGH FEMORAL ARTERY ACCESS. THE UNSPECIFIED PRIMARY WIRE WAS EXCHANGED WITH THE VIPERWIRE. TREATMENT STARTED ON LOW SPEED, FOLLOWED BY TWO TO THREE TREATMENTS ON MEDIUM THEN THREE TREATMENTS ON HIGH SPEED. BALLOON ANGIOPLASTY USING ABBOTT SURVEIL DRUG-COATED BALLOON (DCB) WAS PERFORMED. ANGIOGRAPHIC IMAGING POST DCB ANGIOPLASTY REVEALED VIPERWIRE FRACTURED TIP IN THE TIBIOPERONEAL (TP) TRUNK. THE FACTURE OCCURRED ONE CM FROM THE MARKER, AND APPROXIMATELY HALF OF THE RADIOPAQUE TIP BROKE. THE FRACTURED COMPONENT WAS SUCCESSFULLY SNARED. THE PHYSICIAN BELIEVES THEY SPUN TOO CLOSE TO THE DISTAL VIPERWIRE AS THE TIP OF THE VIPERWIRE WAS OFF THE SCREEN DURING TREATMENTS. THE PATIENT WAS STABLE. THERE WAS NO OAD CROWN JUMP OR VIPERWIRE BIAS. NO DAMAGE/ISSUES PRIOR TO SEPARATION WERE OBSERVED. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "TIP OF WIRE BROKE OFF INSIDE OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184062 ↗
• MalfunctionMar 17, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE TREATMENT AREA WAS A 85% STENOSED, MODERATELY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY. AFTER TREATMENT WITH THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE WIRE BRAKE WAS RELEASED AND AN ATTEMPT WAS MADE TO REMOVE THE OAD. THE OAD WAS STUCK ON THE VIPERWIRE ADVANCE PERIPHERAL GUIDEWIRE AND COULD NOT RELEASE. TROUBLESHOOTING WAS PERFORMED BY LOCKING AND UNLOCKING THE BRAKE IN AN ATTEMPT TO RELEASE THE OAD FROM THE WIRE, BUT WAS UNSUCCESSFUL. THE OAD AND THE GUIDEWIRE WERE REMOVED TOGETHER, AND THE LESION WAS WIRED AGAIN TO COMPLETE THE PROCEDURE. THE RETURNED PRODUCT TO THE MANUFACTURER SHOWED BLOOD BACKED UP INTO THE OAD AND DEVICE ANALYSIS IDENTIFIED MATERIAL SEPARATION OF THE GUIDEWIRE SPRING TIP. IT WAS NOTED THAT THE FORWARD SALINE FLOW WAS NOT STOPPED AT ANY TIME DURING THE PROCEDURE AND PUMP WAS NOT TURNED OFF PRIOR TO REMOVAL OF THE OAD. IN THE OPINION OF THE PHYSICIAN, THE FLOW WAS SUFFICIENT TO AVOID INJURY TO THE PATIENT. THE PATIENT WAS STABLE WITH NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21622175 ↗
• InjuryNov 15, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% CALCIFIED LEFT COMMON FEMORAL ARTERY AND 50%-70% DIFFUSED SUPERFICIAL FEMORAL ARTERY USING AN EMBOSHIELD NAV 6 FILTER WITH A 6F SHEATH AND A VIPERWIRE ADVANCE GUIDEWIRE. THE NAV 6 FILTER CROSSED THE TARGET LESION, HOWEVER WHEN RETRIEVING THE DEVICE, THE TIP OF THE GUIDEWIRE BROKE OFF INTO TWO PIECES AND THE GUIDEWIRE ABOUT 1 CM IN LENGTH REMAINED IN THE PATIENT. THE WIRE TIP WAS EMBEDDED IN A BRANCH POST PROCEDURE. THE EMBOSHIELD NAV 6 FILTER WAS REMOVED WITH THE SHEATH AND IN THE PHYSICIAN'S OPINION, THE PATIENT WILL NEED ADDITIONAL INTERVENTION TO RETRIEVE THE GUIDE WIRE TIP AND DOES NOT HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES. MANUAL COMPRESSION WAS HELD AFTER REMOVAL OF SHEATH WITH NAV 6 FILTER AND WIRE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20698710 ↗
• InjuryNov 8, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED A VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WAS USED FOR TREATMENT OF CALCIFIED LESION IN SUPERFICIAL FEMORAL ARTERY (SFA). THE ABBOTT EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM WAS POSITIONED IN POPLITEAL AND USED WITH THE VIPERWIRE. FOLLOWING FIVE CSI ATHERECTOMY TREATMENTS, THE TIP OF THE VIPERWIRE FRACTURED UPON RETRIEVAL OF THE NAV6 FILTER. THE VIPERWIRE TIP WAS SUCCESSFULLY SNARED. THE PATIENT WAS STABLE AND DISCHARGED HOME WITHOUT FURTHER COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642209 ↗
• InjuryJul 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A .014 INCH VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WAS USED FOR TREATMENT OF A HIGHLY CALCIFIED, 80% STENOSED LESION IN LEFT ANTERIOR TIBIAL ARTERY. THE VESSEL DIAMETER WAS 3MM. THE NURSE OPENED THE VIPERWIRE AND HANDED IT TO THE TECHNICIAN. THE TECHNICIAN INSERTED THE VIPERWIRE INTO THE PATIENT. THE NURSE WENT TO SCAN THE VIPERWIRE AND REALIZED IT WAS EXPIRED. THE VIPERWIRE WAS REMOVED AFTER BEING IN VIVO FOR 60 SECONDS AND DISCARDED. A .018 INCH NON-ABBOTT SUPPORT CATHETER WAS INSERTED THEN EXCHANGED WITH A TAPERED VIPERWIRE WITH A GOOD EXPIRATION DATE. THE PATIENT WAS TREATED WITH A DOSE OF ANTIBIOTICS IN THE MIDDLE OF THE PROCEDURE TO PREVENT INFECTION FROM THE EXPIRED VIPERWIRE. THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810368 ↗
• InjuryMar 11, 2024Material Separation; Material Separation

  THE VIPERWIRE ADVANCE GUIDE WIRE TIP FRACTURED IN VIVO. A SNARE WAS USED TO REMOVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION AND DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18874772 ↗
• InjuryNov 20, 2023Material Separation; Material Separation

  THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE FRACTURED DURING REMOVAL AFTER TREATMENT OF THE POPLITEAL ARTERY. THE PHYSICIAN STATED THEY TREATED WITH THE ORBITAL ATHERECTOMY DEVICE (OAD) WITHIN 1 CENTIMETER FROM THE SPRING TIP BUT DID NOT MAKE CONTACT WITH THE WIRE. A SNARE WAS USED TO RETRIEVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18173950 ↗
• InjuryMay 17, 2023Material Separation; Material Separation

  THE VIPERWIRE ADVANCE GUIDE WIRE WAS ADVANCED THROUGH A TELEPORT CATHETER INTO THE PEDAL VESSELS. THE WIRE WAS ADVANCED INTO A DISTAL, SIDE BRANCH OF THE PEDAL VESSELS AND THE TIP OF THE GUIDE WIRE FRACTURED UPON PULLING BACK THE WIRE. THE GUIDE WIRE WAS REPLACED. UPON COMPLETING THE PROCEDURE, THE REPLACEMENT GUIDE WIRE CAUGHT ONTO THE FRACTURED TIP AND REMOVED THE COMPONENT. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16950542 ↗
• InjuryJan 6, 2023Material Separation; Material Separation

  A DIAMONDBACK 360 PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 5MM, CALCIFIED LESION IN THE MID POPLITEAL. THERE WAS A PREVIOUSLY PLACED STENT IN THE DISTAL SIDE OF THE POPLITEAL. THE VIPERWIRE ADVANCE GUIDE WIRE WAS PLACED IN THE DISTAL SIDE OF THE STENT. THE OAD WAS USED TO BEGIN TREATMENT OF THE MID POPLITEAL. AFTER TWO OR THREE TREATMENTS, THE OAD WAS ADVANCED TOO CLOSE TO THE VIPERWIRE AND FRACTURED THE SPRING TIP, AS THE VIPERWIRE WAS UNABLE TO BE ADVANCED MORE DISTALLY. THE SPRING TIP WAS SNARED. A NEW VIPERWIRE AND NON-CSI DEVICES WERE USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16113825 ↗
• MalfunctionOct 7, 2022Material Separation; Material Separation

  FOLLOWING ATHERECTOMY TREATMENT FOR CALCIFIED VESSELS, WHILE REMOVING THE VIPERWIRE ADVANCE GUIDE WIRE THROUGH A NON-CSI CATHETER, THE TIP FRACTURED. THE TIP FRAGMENT SEPARATED INSIDE THE BALLOON CATHETER. THE PHYSICIAN REMOVED THE BALLOON AND WIRE. THE PATIENT EXPERIENCED NO COMPLICATION RESULTING FROM THIS EVENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15566486 ↗
• InjuryNov 24, 2021Material Separation; Material Separation

  ORBITAL ATHERECTOMY (OA) TREATMENT WAS PERFORMED TO THE MID AND DISTAL SUPERFICIAL FEMORAL ARTERY FOR SEVEN TREATMENT PASSES. FOLLOWING OA, IMAGING REVEALED THAT APPROXIMATELY 15MM OF THE RADIOPAQUE PORTION OF THE VIPERWIRE GUIDE WIRE HAD FRACTURED. THE TIP OF THE GUIDE WIRE REMAINED DISTAL FROM THE CROWN OF THE ORBITAL ATHERECTOMY DEVICE. THE FRAGMENT WAS RETRIEVED WITH A SNARE DEVICE AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12869653 ↗
• InjuryNov 9, 2021Material Separation; Material Separation

  DURING TREATMENT OF A LESION IN THE ANTERIOR TIBIAL ARTERY, THE VIPERWIRE GUIDE WIRE ADVANCED DEEPER THAN ORIGINALLY POSITIONED. WHEN THE ORBITAL ATHERECTOMY DEVICE WAS STOPPED AND REPOSITIONED, IT WAS NOTED THAT THE TIP OF THE WIRE WAS NOT MOVING SYNCHRONOUSLY. THE VIPERWIRE WAS RETRACTED AND OBSERVED TO HAVE FRACTURED. THE FRACTURE OCCURRED IN THE AREA OF THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, PARTIALLY IN THE SHEATH. A SMALL BALLOON WAS ADVANCED AND USED TO TRAP THE FRACTURED WIRE IN THE DISTAL SECTION OF THE SHEATH. THE SHEATH AND WIRE WERE THEN REMOVED AND REPLACED TO CONTINUE THE PROCEDURE WITH NO PATIENT ISSUES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12782789 ↗

Other Cardiovascular Systems, Inc. products

• Diamondback Coronary7 models · 616 reports
• Diamondback Peripheral33 models · 346 reports
• Stealth17 models · 225 reports
• ViperWire2 models · 214 reports
• ViperWire Advance FlexTip4 models · 188 reports