HI-TORQUE VERSATURN 1013317JRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648198472), received between Jul 31, 2018 and Sep 17, 2026 — classified as 5 injuries, 3 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.

• InjurySep 17, 2026Difficult to Remove; Material Separation

  It was reported that the HT Versaturn guidewire was used in a 100% in-stent restenosis in the left circumflex coronary artery. The guidewire was able to cross the lesion; however, the guidewire broke during removal. A snare was used to successfully retrieve the separated segment of the wire. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802915 ↗
• MalfunctionApr 3, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER WAS USED AND AFTER OPTICAL COHERENCE TOMOGRAPHY (POST SOFT RADIOPAQUE PORTION), THE VERSATURN GUIDE WIRE WAS ATTEMPTED TO BE RE-ADVANCED IN ANOTHER VESSEL AND COULD NOT BE ADVANCED. THE GUIDE WIRE WAS REMOVED INDEPENDENTLY AND WAS NOTED TO HAVE UNRAVELED BUT WAS STILL INTACT. ANOTHER VERSATURN GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ISSUE WITH THE DRAGONFLY OPTIS IMAGING CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS NOTED UPON FURTHER REVIEW: THE GUIDE WIRE WAS REMOVED INDEPENDENTLY AND WAS NOTED TO HAVE UNRAVELED (PAST SOFT RADIOPAQUE PORTION) BUT WAS STILL INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037789 ↗
• InjuryJul 13, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. DURING USE WITH THE 014 HT VERSATURN GUIDE WIRE, IT WAS NOTED THAT THE TEFLON COATING WAS PEELING AND COMING OFF. ANOTHER NON-ABBOTT GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17317559 ↗
• MalfunctionDec 28, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING USE, AN UNKNOWN MARKER WAS FOUND ON A VERSATURN F GUIDE WIRE. UNSPECIFIED DEVICES WERE 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 Consequences Or Impact To Patient

  MAUDE report 11083853 ↗
• MalfunctionDec 1, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AN UNKNOWN MARKER WAS SEEN ON THE VERSATURN F GUIDE WIRE. 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 10928642 ↗
• InjuryAug 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED EXPERIENCING A NON-ST-ELEVATION MYOCARDIAL INFARCTION. THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WAS 99% OCCLUDED. THE DIAGONAL BRANCH WAS 70% OCCLUDED. THE VERSATURN GUIDE WIRE WAS ADVANCED INTO THE DIAGONAL ARTERY TO KEEP THE PATHWAY TO ARTERY OPEN AND A NON-ABBOTT DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE LAD, JAILING THE VERSATURN GUIDE WIRE. DURING REMOVAL OF THE GUIDE WIRE, THE DISTAL PORTION OF THE WIRE BROKE OFF. A NON-ABBOTT STENT WAS IMPLANTED IN THE DIAGONAL TO TREAT THE LESION AND TO STABILIZE THE DISTAL PORTION OF THE SEPARATED WIRE. THE PROXIMAL PORTION OF THE SEPARATED GUIDE WIRE WAS EMBEDDED INTO THE VESSEL WALL OF THE LAD. THE FINAL OUTCOME OF THE PROCEDURE WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 10405202 ↗
• InjuryNov 7, 2018Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT DURING A LEFT ANTERIOR DESCENDING (LAD) ARTERY INTERVENTION, THE VERSATURN GUIDE WIRE WAS POSITIONED IN THE DIAGONAL BRANCH AS A VESSEL STABILIZER. A NON-ABBOTT STENT WAS IMPLANTED AND POST-DILATATION WAS COMPLETED. DURING REMOVAL OF THE VERSATURN WITHOUT RESISTANCE, THE GUIDE WIRE SEPARATED DISTALLY AND WAS ENTRAPPED UNDER THE IMPLANTED STENT AND SLIGHTLY PROTRUDING INTO THE DIAGONAL BRANCH. ANOTHER NON-ABBOTT STENT WAS IMPLANTED TO STABILIZE THE DETACHED PORTION OF THE VERSATURN WIRE. THE PATIENT WAS REPORTED AS OK AND THE OUTCOME REPORTED AS NORMAL. THE PATIENT WAS DISCHARGED THE NEXT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8048496 ↗
• InjuryJul 31, 2018Entrapment 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 DE NOVO LESION, BELOW THE BIFURCATION OF THE MARGINAL AND LEFT ANTERIOR DESCENDING CORONARY ARTERIES. ON REMOVAL OF A HIGH TORQUE VERSATURN GUIDEWIRE, RESISTANCE WITH A NON-ABBOTT STENT WAS FELT. THE GUIDEWIRE WAS REMOVED WITH FORCE AND A SEPARATION OCCURRED AT THE DISTAL RADIOPAQUE PORTION OF THE WIRE. THE TIP OF THE GUIDEWIRE REMAINED CAUGHT BY THE STENT. RETRIEVAL OF THE SEPARATED PORTION OF THE GUIDEWIRE WITH AN ADDITIONAL UNSPECIFIED WIRE WAS ATTEMPTED BUT FAILED. THE SEPARATED PORTION OF THE GUIDEWIRE REMAINED IN THE ANATOMY. THE PATIENT CONDITION WAS REPORTED TO BE GOOD. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7735813 ↗