Extended Length ViperWire Advance VPR-GW-EL14Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10852528005459), received between May 30, 2018 and Sep 23, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT MODERATELY CALCIFIED, NON-TORTUOUS, 99% STENOSED ANTERIOR TIBIAL ARTERY (AT) WITH 1.25 MICRO DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE, EXTENDED LENGTH WAS SCANNED BY THE NURSE AND IT SHOWED THE VIPERWIRE EXPIRED ON (B)(6) 2025 TWO DAYS PRIOR TO THE PROCEDURE. THE VIPERWIRE EXPIRED ON THE ACCOUNT¿S SHELF. THE PHYSICIAN WAS INFORMED BUT DECIDED TO USE THE EXPIRED VIPERWIRE DURING ATHERECTOMY TREATMENT. THE PATIENT WAS STABLE. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23125130 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN PERFORMING ATHERECTOMY ON A LESION IN THE DISTAL PERONEAL ARTERY, A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED WITH A VIPERWIRE GUIDE WIRE THAT WAS NOT LONG ENOUGH. A LONGER VIPERWIRE ADVANCE GUIDE WIRE WAS THEN USED. A FLOW LIMITING DISSECTION HAD OCCURRED, IDENTIFIED VIA ANGIOGRAPHY. BALLOON ANGIOPLASTY WAS PERFORMED TO RESOLVED. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 16142075 ↗
• InjuryApr 22, 2022Material Separation; Material Separation

  THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL WERE PRIMARY WIRED WITH A VIPERWIRE GUIDE WIRE, AND PLACEMENT WAS CONFIRMED ON IMAGING. THE TREATMENT AREA WAS NOT TORTUOUS BUT WAS HIGHLY CALCIFIED. ONE SECTION OF THE VESSEL WAS TREATED WITH ATHERECTOMY. THEREAFTER, WIRE PLACEMENT WAS CHECKED AND FOUND TO BE IN THE DESIRED LOCATION. THE ATHERECTOMY DEVICE WAS ADVANCED, AND WIRE PLACEMENT WAS AGAIN CONFIRMED TO BE CORRECT. TREATMENTS WERE PERFORMED WITH A RADIAL LENGTH ORBITAL ATHERECTOMY DEVICE ON LOW, MEDIUM, AND HIGH SPEED. EACH TREATMENT TIME WAS ABOUT 20-25 SECONDS, AND REST TIME WAS EQUAL TO TREATMENT TIME. DURING MOVEMENT OF THE OAD, THE WIRE MIGRATED INTO A SMALL SIDE VESSEL. ATHERECTOMY WAS THEN PERFORMED IN THE POPLITEAL VESSEL. THE OAD WAS REMOVED, AND WIRE POSITION WAS CHECKED ON IMAGING. PLACEMENT AT THAT TIME WAS OBSERVED TO BE LESS THAN IDEAL. THE WIRE WAS PULLED BACK, AND IMAGING INDICATED THE WIRE HAD FRACTURED. THE TIP OF THE WIRE REMAINED IN THE SIDE VESSEL. THE REMAINDER OF THE WIRE WAS REMOVED INTACT. ADDITIONAL IMAGING CONFIRMED THE WIRE FRAGMENT WAS IN A SMALL SIDE BRANCH AND NOT IN THE PERONEAL ARTERY. THE OPINION OF THE PHYSICIAN WAS THAT THE FRAGMENT WOULD BE "

  Patient problems: Foreign Body In Patient

  MAUDE report 14186847 ↗
• InjuryMay 26, 2021Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  ORBITAL ATHERECTOMY TREATMENT WAS SUCCESSFULLY PERFORMED VIA LEFT RADIAL ACCESS TO THE LEFT POPLITEAL (PA) AND COMMON FEMORAL ARTERIES WITHOUT ISSUE, AND THE ORBITAL ATHERECTOMY DEVICE WAS REMOVED FROM THE PATIENT'S BODY. A BALLOON WAS INSERTED OVER THE VIPERWIRE GUIDE WIRE TO TREAT THE PA AND BALLOON ANGIOPLASTY WAS SUCCESSFULLY PERFORMED. DURING THE REMOVAL PROCESS THE BALLOON BECAME STUCK, AND THE GUIDE WIRE WAS PULLED, HOWEVER A KINK WAS OBSERVED IN THE GUIDE WIRE WHICH PREVENTED THE BALLOON FROM BEING REMOVED. THE SHEATH, BALLOON AND WIRE WERE PULLED BACK INTO THE MID AORTA AND ACCESS TO THE RIGHT GROIN WAS OBTAINED IN ORDER TO SNARE THE WIRE FROM BELOW, HOWEVER THIS ATTEMPT WAS UNSUCCESSFUL. THE BALLOON, WIRE AND SHEATH WERE THEN REMOVED FROM THE RADIAL ACCESS SITE. IMAGING WAS PERFORMED AND CONFIRMED A TYPE F DISSECTION IN THE AXILLARY ARTERY AND A VESSEL SPASM IN THE RADIAL ARTERY. VASCULAR SURGERY WAS CONSULTED, AND IT WAS DETERMINED THAT NO FURTHER TREATMENT WAS REQUIRED AND THE PATIENT WOULD BE MONITORED, HOWEVER THE FOLLOWING DAY A CORONARY BYPASS SURGERY WAS PERFORMED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vascular Dissection

  MAUDE report 11890521 ↗
• InjuryMay 19, 2021Material Separation; Material Separation

  DURING A PROCEDURE WITH A PERIPHERAL VIPERWIRE GUIDE WIRE AND ORBITAL ATHERECTOMY DEVICE (OAD), THE VIPERWIRE FRACTURED IN THE POPLITEAL ARTERY. A FRAGMENT OF THE WIRE WAS RETRIEVED VIA A SNARE. ADDITIONAL FRAGMENTS REMAINED IN VIVO, AND WERE BALLOONED INTO THE VESSEL WALL OF AN UNKNOWN TIBIAL VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 11850840 ↗
• MalfunctionOct 7, 2020Material Separation; Material Separation

  THE VIPERWIRE GUIDE WIRE WAS USED AS THE PRIMARY CROSSING WIRE FOR LESIONS IN THE LEFT SUPERFICIAL FEMORAL AND TIBIAL PERONEAL TRUNK ARTERIES. ORBITAL ATHERECTOMY (OA), BALLOON ANGIOPLASTY, AND STENT PLACEMENT WERE PERFORMED OVER THE GUIDE WIRE. THE GUIDE WIRE WAS THEN REMOVED AND RE-INSERTED AS THE PRIMARY CROSSING WIRE FOR A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. OA WAS PERFORMED WITHOUT ISSUE. RESISTANCE IN THE SHEATH WAS ENCOUNTERED WHEN THE OAD WAS REMOVED. THERE WAS DIFFICULTY ADVANCING A STENT THROUGH THE SHEATH, AND THE GUIDE WIRE WAS REMOVED SO A SHEATH REPLACEMENT COULD BE PERFORMED. PRIOR TO REMOVING THE SHEATH, A GUIDE WIRE FRAGMENT WAS OBSERVED PROTRUDING OUT OF THE SHEATH. THE GUIDE WIRE HAD FRACTURED AND THE FRAGMENT WAS REMOVED FROM THE SHEATH. THERE WERE NO FRAGMENTS IN THE PATIENT'S BODY AND THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-CSI GUIDE WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10642267 ↗
• InjuryJun 5, 2020Material Separation; Material Separation

  A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE GUIDE WIRE WERE USED TO TREAT A TARGET LESION IN A PERIPHERAL CASE. THERE WAS COMPLETE CALCIUM AND PLAQUE BURDEN OBSERVED IN THE COMMON ILIAC AND SUPERFICIAL FEMORAL ARTERY(SFA). NON-CSI DEVICES WERE UNABLE TO PASS DUE TO THE CALCIUM, AND CSI WAS SELECTED FOR TREATMENT. THE GUIDE WIRE WAS ADVANCED TO THE SFA, AND THE OAD WAS OPERATED ON LOW, MEDIUM AND HIGH SPEED FOR TWO TREATMENT PASSES ON EACH SPEED. AS THE DEVICE WAS PULLED BACK DURING A TREATMENT PASS ON HIGH SPEED NEAR THE BIFURCATION, THE VIPERWIRE FRACTURED. THE OAD WAS REMOVED, AND THE REMAINING WIRE FRAGMENT WAS RETRIEVED WITH THE USE OF A SNARE. THE PATIENT WAS REPORTEDLY IN "OK" CONDITION. IN THE OPINION OF THE PHYSICIAN, THE FRACTURE OCCURRED DUE TO COMBINATION OF THE CALCIUM BURDEN AND TENSION OF THE DEVICE FROM BEING NEAR THE BIFURCATION. THE PHYSICIAN FELT THIS WAS DUE TO USER ERROR.

  Patient problems: Foreign Body In Patient

  MAUDE report 10123160 ↗
• InjuryMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A VESSEL SPASM OCCURRED. THE TARGET LESION WAS 100% STENOSED AND LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY. FOLLOWING TREATMENT WITH THE OAD, A VESSEL SPASM OCCURRED IN THE PERONEAL. THE GUIDE WIRE WAS REMOVED AND VASODILATORS WERE ADMINISTERED TO RESOLVE THE SPASM. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7554577 ↗