HI-TORQUE VERSATURN 1013319JRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648198496), received between Aug 8, 2019 and Sep 9, 2026 — classified as 1 death, 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Difficult to Remove; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701651 ↗
• DeathApr 24, 2026Break; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND AN NON-ABBOTT STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA). A 014 HT VERSATURN GUIDE WIRE (GW) WAS ADVANCED TO BE USED AS A PROTECTIVE GW; HOWEVER, THE GW BECAME ENTRAPPED IN THE MARGINAL BRANCH ORIGINATING FROM THE RIGHT CORONARY ARTERY (RCA). MULTIPLE ATTEMPTS TO RETRIEVE THE GW WERE MADE BUT ALL WERE UNSUCCESSFUL. THE ATTEMPTS TO RETRIEVE THE ENTRAPPED GW CAUSED THE GW TO FRACTURE. THEN TWISTED UNSPECIFIED GUIDE WIRES WERE USED TO SNARE THE FRACTURED GW. THE FRACTURED GW WAS FREED FROM THE MARGINAL BRANCH; HOWEVER, THE FRACTURED GW AND THE TWISTED GUIDE WIRES REMAINED TRAPPED IN THE RCA, RESULTING IN THE GUIDE WIRES TO BECOME ENTANGLED WITH THE PREVIOUSLY IMPLANTED STENT. AS A RESULT, THE IMPLANTED STENT BECAME STRUCTURALLY COMPROMISED. ANGIOGRAPHY SHOWED IN-STENT RE-OCCLUSION OF THE RIGHT CORONARY ARTERY, ASSOCIATED WITH DISSECTION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, WITH PRESERVED RESPIRATORY STATUS AND ELECTRICAL STABILITY (NO ST-SEGMENT ELEVATION, NO RHYTHM DISTURBANCES). THE GUIDING CATHETER WAS REMOVED, WITH THE ENTRAPPED GUIDEWIRES LEFT IN PLACE FOR PATIENT TRANSFER TO EMERGENCY SURGERY TO

  Patient problems: Unspecified Heart Problem

  MAUDE report 24975318 ↗
• InjuryNov 21, 2024Stretched; Stretched

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE VERSATURN GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION AND ATTEMPTS WERE MADE TO ADVANCE A 2.50X15MM AND 1.20X20MM BALLOON CATHETER TO THE NARROWED VESSEL HOWEVER WERE UNSUCCESSFUL. DURING CHANGING POSITION OF THE GW THE TIP WAS NOTED TO HOOK ON THE ATHEROSCLEROTIC PLAQUE, RESULTING IN THE TIP STRETCHING. DURING THESE MANIPULATIONS, A TRANSIENT DECREASE IN BP 60/40 AND BRADYCARDIA OCCURRED. THE PRESSURE WAS EQUALIZED BY ADMINISTERING 1MG OF ATROPINE AND 500ML OF 0.9%. AFTER THE PATIENT¿S BLOOD PRESSURE WAS EQUALIZED, SYMPTOMS OF INSUFFICIENT CEREBRAL CIRCULATION WERE OBSERVED. IT WAS DECIDED TO DISCONTINUE THE PROCEDURE AT THIS POINT. THE "PATIENT'S" SYMPTOMS LAST APPROXIMATELY 5 MINUTES POST PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia; Transient Ischemic Attack

  MAUDE report 20744782 ↗
• InjuryDec 5, 2023Difficult to Remove; Material Separation; Stretched; Device Damaged by Another Device; Difficult to Remove; Material Separation; Stretched; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) AND DIAGONAL CORONARY ARTERY BIFURCATION WITH HIGH CALCIFICATION. THE VERSATURN GUIDE WIRE WAS PLACED IN THE DIAGONAL ARTERY AND A NON-ABBOTT GUIDE WIRE WAS PLACED IN THE LAD. A NON-COMPLIANT BALLOON WAS USED DUE TO THE HIGH CALCIFICATION AND THEN A STENT WAS THEN IMPLANTED IN THE LAD. THIS TRAPPED THE VERSATURN GUIDE WIRE AND THE DISTAL TIP SEPARATED AND THE WIRE UNRAVELED. THE DISTAL TIP REMAINS FREE FLOATING IN THE ARTERY AND NO DILATATION OF THE DIAGONAL ARTERY WAS ABLE TO BE PERFORMED. THE PATIENT WAS DOING WELL AT THE END OF THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18267910 ↗
• MalfunctionSep 12, 2023Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH 90% STENOSIS, NO CALCIFICATION AND MILD TORTUOSITY. THE VERSATURN GUIDE WIRE WAS USED IN THE LCX AND NOTED TO HAVE STRETCHED AND GOT CAUGHT ON THE STENT'S STRUT DURING REMOVAL. ANOTHER VERSATURN GUIDE WIRE WAS USED TO TREAT THE OBTUSE MARGINAL (OM) AND HAD STRETCHED COILS PROBABLY FROM THE FIRST GUIDE WIRE. THE GUIDE WIRES WERE REMOVED INDEPENDENTLY. IT WAS NOTED ON BOTH VERSATURN GUIDE WIRES THAT THE CORE AND COILS WERE NOT INTACT. THE VERSATURN GUIDE WIRE USED IN THE LCX WAS NOTED TO POSSIBLY HAVE FRAGMENTS OF COIL ON THE VERSATURN GUIDE WIRE USED IN THE OM. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732917 ↗
• MalfunctionSep 12, 2023Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH 90% STENOSIS, NO CALCIFICATION AND MILD TORTUOSITY. THE VERSATURN GUIDE WIRE WAS USED IN THE LCX AND NOTED TO HAVE STRETCHED AND GOT CAUGHT ON THE STENT'S STRUT DURING REMOVAL. ANOTHER VERSATURN GUIDE WIRE WAS USED TO TREAT THE OBTUSE MARGINAL (OM) AND HAD STRETCHED COILS PROBABLY FROM THE FIRST GUIDE WIRE. THE GUIDE WIRES WERE REMOVED INDEPENDENTLY. IT WAS NOTED ON BOTH VERSATURN GUIDE WIRES THAT THE CORE AND COILS WERE NOT INTACT. THE VERSATURN GUIDE WIRE USED IN THE LCX WAS NOTED TO POSSIBLY HAVE FRAGMENTS OF COIL ON THE VERSATURN GUIDE WIRE USED IN THE OM. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732909 ↗
• MalfunctionJun 23, 2023Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE VERSATURN GUIDEWIRE(B)(4) (GW) WAS ATTEMPTED TO BE USED IN A PROCEDURE; HOWEVER, THE GW MET WITH RESISTANCE WITH THE CATHETER. THEREFORE, THE GW WAS REMOVED FROM THE PATIENT AND DELAMINATION [PEELING] WAS NOTED ON THE GW. ANOTHER GW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191964 ↗
• InjuryApr 26, 2023Entrapment of Device; Difficult to Remove; Stretched; Entrapment of Device; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A BIFURCATION IN THE DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 014 HT VERSATURN GUIDEWIRE WAS ADVANCED AND AN UNSPECIFIED STENT WAS IMPLANTED; HOWEVER, THE GUIDE WIRE BECAME JAILED. THE GUIDE WIRE WAS ATTEMPTED TO BE REMOVED; HOWEVER, WAS NOTED TO BE STRETCHED. A BALLOON WAS ADVANCED ON THE GUIDE WIRE UP TO THE STENT. THE GUIDE WIRE AND THE BALLOON WERE THEN REMOVED AS A SINGLE UNIT. THE GUIDE WIRE WAS ABLE TO BE COMPLETELY REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817652 ↗
• InjuryAug 3, 2022Break; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Break; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A IN-STENT RESTENOSIS AT BIRFURCATION OF THE RIGHT CORONARY ARTERY AND POSTERIOR DESCENDING ARTERY. POST DILATATION WAS PERFORMED POST STENT IMPLANTATION. DURING POST DILATATION, THE VERSATURN GUIDE WIRE BECAME STUCK/JAILED BETWEEN AN OLD UNSPECIFIED STENT AND THE NEWLY UNSPECIFIED PLACED STENT AND THE GUIDE WIRE BECAME UNRAVELED. A GUIDELINER WAS THEN ADVANCED AND ASSISTED IN GETTING ALL OF THE WIRES WITHDRAWN FROM THE ANATOMY ALTOGETHER. ONCE REMOVED IT WAS NOTED THAT THE GUIDE WIRE CORE SEPARATED IN TWO PIECES BUT HAD BEEN ABLE TO BE ALL RETRIEVED WHEN IT WAS WITHDRAWN. NOTHING REMAINED IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160545 ↗
• MalfunctionJun 22, 2021Break; Difficult to Remove; Failure to Advance; Material Twisted/Bent; Break; Difficult to Remove; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY (LAD). PRE-DILATATION WAS PERFORMED WITH A TREK BALLOON AND THEN PULLED THE VERSATURN GUIDE WIRE (GW) INTO THE OSTIUM, STENTED, TRIED TO PUT THE VERSATURN BACK INTO DISTAL LAD WHERE THE EXTRA S¿PORT WIRE WAS LOCATED. RESISTANCE WAS NOTED WITH THE PREVIOUSLY DEPLOYED STENT WHEN ADVANCING THE VERSATURN GW AND DISTAL 30MM OF THE RADIOPAQUE PORTION OF THE WIRE LOOKED LIKE IT WAS TWISTED AROUND ITSELF. THERE WERE ALSO ISSUES REMOVING THE GUIDE WIRE DUE TO THE PREVIOUSLY DEPLOYED STENT. ULTIMATELY THE GUIDE CATHETER WAS PULLED BACK, ALONG WITH THE VERSATURN AND REMOVED ALTOGETHER. UPON REMOVAL OF THE VERSATURN, IT WAS NOTICED THAT THE DISTAL END OF THE WIRE WAS UNCOILED. A PROWATER GW WAS USED INSTEAD TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041269 ↗
• InjuryJun 1, 2021Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS USED WITH A VERSATURN GUIDE WIRE WITHOUT RESISTANCE. THE STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, THE TIP OF THE GUIDE WIRE GOT CAUGHT IN BETWEEN THE IMPLANTED STENT AND THE ARTERY WALL AND BECAME SEPARATED. IT WAS CONFIRMED THAT THE STENT IS FINE, AND THE TIP REMAINS EMBEDDED IN THE ANATOMY. NO TREATMENT HAS BEEN PERFORMED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11916090 ↗
• MalfunctionFeb 3, 2021Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE HIGH-TORQUE VERSATURN F GUIDEWIRE WAS ADVANCED TO THE LESION. A NON-COMPLIANT NON-ABBOTT BALLOON WAS ADVANCED OVER THE GUIDEWIRE TO THE LESION THEN REMOVED AFTER DILATATION WAS PERFORMED. RESISTANCE WAS FELT DURING THE WITHDRAWAL OF THE BALLOON CATHETER OVER THE GUIDEWIRE. IT WAS THEN OBSERVED VIA ANGIOGRAPHY THAT THE COILS WERE UNRAVELED. THE GUIDEWIRE WAS REMOVED VERY EASILY WITHOUT COMPLICATIONS. A NEW VERSATURN F GUIDEWIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275853 ↗
• MalfunctionJan 27, 2021Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED OVER A 014 HT VERSATURN GUIDE WIRE; HOWEVER, IT WAS OBSERVED THAT A MARKER MOVED. THE MARKER MOVED TO THE DISTAL PORTION OF THE GUIDE WIRE, BUT REMAINED ON THE GUIDE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11237347 ↗
• InjurySep 3, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A CASE TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE HIGH TORQUE VERSATURN GUIDE WIRE (GW) WAS INSERTED; HOWEVER, RESISTANCE WAS FELT. THE GW WAS SLIGHTLY PULLED, BUT IT WAS NOTICED THAT THE GW HAD BROKEN. TO RECOVER THE BROKEN PIECE, A SNARE WAS INSERTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY I THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10487958 ↗
• MalfunctionJun 30, 2020Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT DURING THE PROCEDURE TREATING A BIFURCATION LESION, THE HI TORQUE VERSATURN GUIDE WIRE GOT CAUGHT BETWEEN A XIENCE SIERRA STENT AND THE VESSEL WALL. DURING REMOVAL, THE GUIDE WIRE CORE BROKE AND THE COILS BECAME STRETCHED. WITH SOME RESISTANCE, THE ENTIRE GUIDE WIRE WAS ABLE TO BE REMOVED FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215348 ↗
• InjuryMar 14, 2020Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VERSATURN GUIDE WIRE WAS ADVANCED DISTALLY TO THE LESION AND THE TIP BECAME CAUGHT WITHIN CALCIFICATION IN A SMALL BRANCH. IT WAS ATTEMPTED TO RETRIEVE THE GUIDE WIRE BUT WHEN TURNING/HANDLING RESISTANCE WAS FELT WITH THE ANATOMY AND THE TIP BECAME SEPARATED AND RELEASED IN THE ARTERY. THE TIP IS LOCATED IN THE SMALL BRANCH (NOT IN THE LAD LUMEN) AND WAS LEFT IN THE ANATOMY. THE PROCEDURE CONTINUED SUCCESSFULLY WITH ANOTHER GUIDE WIRE. THE PATIENT REMAINS IN GOOD CONDITION. THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9833124 ↗
• MalfunctionFeb 13, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX LESION. DURING RETRACTION, RESISTANCE WAS MET WITH THE PREVIOUSLY IMPLANTED STENT AND THE COILS SEPARATED; HOWEVER, THE CORE REMAINED INTACT. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. A PILOT 50 GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706496 ↗
• MalfunctionAug 8, 2019Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE MID-DIAGONAL ARTERY WAS HEAVILY CALCIFIED AND 90% STENOSED. RESISTANCE WAS NOTED DURING RETRACTION OF THE GUIDE WIRE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874720 ↗