HI-TORQUE VERSATURN 1013319Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648198458), received between Jan 6, 2017 and Aug 23, 2023 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, AT THE END OF PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE IN THE MID LEFT MAIN, MID LEFT ANTERIOR DESCENDING (LAD), AND PROXIMAL CIRCUMFLEX CORONARY ARTERY USING THE VERSATURN GUIDE WIRE, THERE WAS EVIDENCE OF A SMALL APICAL LAD WIRE PERFORATION WITH A SMALL AMOUNT OF STAINING OF THE MYOCARDIUM. THE PATIENT WAS HYPOTENSIVE POST-PROCEDURE. PATIENT WAS GIVEN INTRAVENOUS FLUIDS, EPINEPHRINE, AND DOPAMINE. A LIMITED ECHOCARDIOGRAM SHOWED PERICARDIAL EFFUSION. CARDIAC TAMPONADE WAS DIAGNOSED. PERICARDIOCENTESIS WAS PERFORMED WITH REMOVAL OF 500 ML SANGUINOUS FLUID. THE PATIENT CONTINUED TO BE HYPOTENSIVE AND AN ADDITIONAL 200 ML SANGUINOUS FLUID WAS REMOVED. PATIENT WAS TRANSFUSED WITH ONE UNIT PACKED RED BLOOD CELLS (PRBC). PATIENT UNDERWENT A REPEAT CORONARY ANGIOGRAM TO ASSESS PERFORATION, WHICH REVEALED THE AREA HAD IMPROVED. HE WAS GIVEN AN ADDITIONAL TWO UNITS PRBCS. ON (B)(6) 2023, ECHOCARDIOGRAM AND LABS WERE STABLE. NO ADDITIONAL FLUID WAS REMOVED FROM THE PERICARDIAL DRAIN AND THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 17603371 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THAT DURING OPENING THE 014 HT VERSATURN F 190, FRACTURES WERE NOTED; HOWEVER, THE DEVICE REMAINED IN ONE PIECE. THERE WAS NOT RESISTANCE MET DURING REMOVAL FROM THE DISPENSER HOOP. ANOTHER NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, 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 16455773 ↗
• MalfunctionFeb 28, 2023Break; Stretched; Contamination /Decontamination Problem; Break; Stretched; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE 014 HT VERSATURN GUIDE WIRE WAS REMOVED FROM PACKAGING AND THE TIP WAS NOTED TO BE FRACTURED. LOOSE SPIRALS IN THAT AREA COULD BE OBSERVED. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455673 ↗
• MalfunctionFeb 23, 2023Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 014 HT VERSATURN F 190 PHC WW GUIDE WIRE (GW).COILS DETACHED DURING ADVANCEMENT; HOWEVER, THE GUIDE WIRE REMAINED IN ONE PIECE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432830 ↗
• MalfunctionFeb 14, 2023Difficult to Remove; Material Separation; Stretched; Difficult to Advance; Difficult to Remove; Material Separation; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE 014 HT VERSATURN F 190 GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION; HOWEVER, DIFFICULTY WAS NOTED WITH THE GUIDE CATHETER (GC). WHEN A STENT WAS PLACED ON THE GW FOR ADVANCEMENT THE PHYSICIAN NOTED THAT THE GW TIP BROKE IN 2 PIECES. THEREFORE, THE GW WAS REMOVED FROM THE PATIENT AND DIFFICULTY WAS NOTED DURING REMOVAL WITH THE GC. A SMALL AMOUNT OF FORCE HAD TO BE APPLIED TO REMOVE THE GW. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN TO THE PROCEDURE. A NON-ABBOTT GW WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373543 ↗
• InjuryJan 5, 2022Peeled/Delaminated; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Peeled/Delaminated; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN THE CIRCUMFLEX (CX) ARTERY. THE HT VERSATURN GUIDE WIRE (GW) WAS POSITIONED TOGETHER WITH A NON-ABBOTT GUIDE WIRE, BUT THE VERSA TURN GW BECAME PROLAPSED. DURING REMOVAL OF THE VERSATURN GUIDE WIRE, RESISTANCE WAS MET AND THE GW BECAME KINKED AND DELAMINATED. A CORONARY PERFORATION WITH PERICARDIAL EFFUSION OCCURRED. THE PATIENT WAS TREATED WITH MEDICATION AND A STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 13172550 ↗
• MalfunctionSep 22, 2020Peeled/Delaminated; Difficult to Remove; Failure to Advance; Peeled/Delaminated; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT IS 90% STENOSED. TWO 014 HT VERSATURN GUIDE WIRES WERE ATTEMPTED TO CROSS THE LESION ONE AFTER ANOTHER HOWEVER; FAILED DUE TO ANATOMY. BOTH TIPS WERE NOTED AS KINKED. A THIRD 014 HT VERSATURN GUIDE WIRE WAS ATTEMPTED TO CROSS THE LESION BUT FAILED DUE TO ANATOMY AND RESISTANCE WITH ANATOMY WAS FELT DURING REMOVAL. IT WAS NOTED THAT THE COATING PEELED BUT STILL REMAINED ON THE GUIDE WIRE. ANOTHER NON-ABBOTT GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10569934 ↗
• MalfunctionJul 24, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. A HI-TORQUE VERSATURN GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT ISSUE. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. WHEN ADVANCING AND REMOVING THE BALLOON, RESISTANCE WAS MET WITH THE GUIDE WIRE. THEN AN UNSPECIFIED DRUG-ELUTING STENT WAS ADVANCED OVER THE GUIDE WIRE, BUT BECAME STUCK ON THE GUIDE WIRE. ALL DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320042 ↗
• InjuryAug 8, 2019Break; Stretched; Break; Stretched

  SUBSEQUENT TO THE 30-DAY INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE GUIDE WIRE UNRAVELED IN THE GUIDE CATHETER AT THE END OF THE PROCEDURE. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER SNARING WITH A NON-COMPLIANT BALLOON. THE FINAL PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874915 ↗
• InjuryMay 7, 2019Difficult 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

  SUBSEQUENT TO FILING THE INITIAL/FINAL MDR, ADDITIONAL INFORMATION WAS RECEIVED. EXCESSIVE FORCE WAS NOT APPLIED ON THE DEVICE DURING PUSHING AND PULLING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8588211 ↗
• InjurySep 12, 2018Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE VERSATURN GUIDE WIRE WAS USED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. AFTER THE PROCEDURE, THE VERSATURN WAS BEING REMOVED FROM THE ANATOMY AND RESISTANCE WAS FELT WITH THE ANATOMY. THE ENTIRE GUIDE WIRE WAS SUCCESSFULLY REMOVED, BUT THE COILS ON THE GUIDE WIRE WERE UNRAVELED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7869674 ↗
• MalfunctionAug 17, 2018Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). THE VERSATURN GUIDE WIRE WAS ADVANCED BUT MET RESISTANCE WITH THE ANATOMY. WHEN THE GUIDE WIRE WAS REMOVED, THERE WERE GREEN PIECES OF COATING REMAINING IN THE COPILOT. THE COPILOT WAS FLUSHED AND FLAKES OF GREEN TEFLON CAME OUT. THERE WAS SOME GREEN TEFLON MISSING 30 MM IN LENGTH HALF WAY DOWN THE GUIDE WIRE. THERE WAS NO RESISTANCE NOTED BETWEEN THE COPILOT AND THE GUIDE WIRE. IT WAS CONFIRMED THAT NO TEFLON ENTERED INTO THE PATIENT VASCULATURE. THE COPILOT WAS USED WITH A NEW BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793464 ↗
• MalfunctionJun 1, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION [CTO] LESION IN THE MILDLY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY. A VERSATURN GUIDE WIRE WAS USED TO SWITCH OUT A NON-ABBOTT CTO GUIDE WIRE AFTER CROSSING THE LESION THROUGH A MICRO-CATHETER. PRE-DILATATION WAS PERFORMED WITH A SMALL NON-ABBOTT BALLOON CATHETER. THE 2.0X15 MM MINI-TREK WAS LOADED ON TO THE VERSATURN GUIDE WIRE, BUT A LOT OF RESISTANCE WAS MET DURING LOADING. RESISTANCE WAS MET DURING REMOVAL OF THE MINI TREK FROM THE VERSATURN GUIDE WIRE; THEREFORE, THE MINI TREK AND THE VERSATURN GUIDE WIRE WERE REMOVED TOGETHER AS A UNIT. OUTSIDE THE ANATOMY, THE MINI TREK WAS ABLE TO BE REMOVED FROM THE VERSATURN. A NEW GUIDE WIRE WAS USED WITH A NON-ABBOTT BALLOON TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7560869 ↗
• InjuryJan 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS TO TREAT A LESION IN THE THIRD OBTUSE MARGINAL BRANCH OF THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. A 014 HT VERSATURN GUIDE WIRE WAS USED FOR THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES NOTED. AFTER RETURNING TO THE CARDIAC WARD FOLLOWING THE PROCEDURE, THE PATIENT'S CONDITION STARTED TO DETERIORATE. IT WAS DISCOVERED THAT THE PATIENT HAD EXPERIENCED CARDIAC TAMPONADE. RE-INTERVENTION WAS PERFORMED AND IT WAS NOTED THAT A PERFORATION HAD OCCURRED IN THE VESSEL MOST LIKELY DUE TO THE USE OF THE VERSATURN GUIDE WIRE USED IN THE INITIAL PROCEDURE. PERICARDIOCENTESIS AND COILING OF THE VESSEL WERE PERFORMED TO STOP THE BLEEDING AND STABILIZE THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Perforation

  MAUDE report 6230566 ↗