HI-TORQUE POWERTURN 1044592Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648173936), received between Oct 17, 2018 and Nov 5, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Difficult to Remove; Material Separation; Material Split, Cut or Torn; Difficult to Remove; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE (HT) POWERTURN GUIDEWIRE WAS ADVANCED TO THE RCA AND A DRAGONFLY OPSTAR IMAGING CATHETER WAS USED TO IMAGE THE RCA. AFTER OBTAINING THE IMAGE, THE CATHETER HAD RESISTANCE DURING REMOVAL FROM THE GUIDEWIRE SO BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THE GUIDEWIRE WAS NOTED TO HAVE SEPARATED AT THE DISTAL END AND THE RADIOPAQUE PORTION OF THE WIRE HAD BEEN SHEARED OFF. FLUOROSCOPY CONFIRMED NOTHING REMAINED IN THE PATIENT. 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 23481992 ↗
• MalfunctionMar 9, 2023Difficult to Remove; Stretched; Device Damaged by Another Device; Difficult to Remove; Stretched; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). TWO POWERTURN GUIDE WIRES WERE ADVANCED TO THEIR INTENDED LOCATION, ONE WIRE DOWN THE DIAGONAL BRANCH. THE 3.5X15MM XIENCE SKYPOINT STENT WAS IMPLANTED, WITHOUT ISSUE, IN THE LAD LESION. DURING REMOVAL OF THE GUIDEWIRE FROM THE DIAGONAL BRANCH, RESISTANCE WAS NOTED, THE GUIDEWIRE BECAME STRETCHED AND, THE SKYPOINT STENT WAS EXPLANTED. A NEW GUIDE WIRE WAS POSITIONED AND A 3.5X18MM XIENCE SKYPOINT WAS ADVANCED AND IMPLANTED IN THE LESION WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519235 ↗
• InjuryMar 20, 2020Entrapment of Device; Difficult to Remove; Material Separation; Stretched; Difficult to Advance; Entrapment of Device; Difficult to Remove; Material Separation; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING THE POWERTURN FLEX GUIDE WIRE DUE TO THE CALCIUM AND TORTUOSITY IN THE MID RIGHT CORONARY ARTERY (RCA), BUT THE GUIDE WIRE WAS SUCCESSFULLY USED FOR THE PROCEDURE. THE MID RCA WAS SUCCESSFULLY TREATED AND HAD BEEN POSTDILATED WITH A 4.0X20 MM NC TREK. THE NC TREK WAS RETRACTED INTO THE GUIDE CATHETER. THE POWERTURN FLEX GUIDE WIRE WAS RETRACTED WITHOUT RESISTANCE WHEN IT BROKE IN THE RCA. ANOTHER POWERTURN FLEX GUIDE WIRE WAS INSERTED IN ORDER TO USE A SNARE TO REMOVE THE SEPARATED WIRE, BUT THE FIRST GUIDE WIRE BROKE AGAIN. THE MIDDLE SEGMENT OF THE SEPARATED WIRE WAS SUCCESSFULLY REMOVED VIA SNARE. ATTEMPTS MADE TO REMOVE THE DISTAL SEPARATED WIRE WITH ANOTHER BALLOON DILATATION CATHETER WERE NOT SUCCESSFUL. IT WAS DECIDED TO IMPLANT ANOTHER STENT IN THE DISTAL RCA TO EMBED THE SEPARATED WIRE. THE UNPLANNED STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9861133 ↗
• InjuryJun 25, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DIAGONAL ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. TWO 190CM POWERTURN FLEX GUIDE WIRE (GW) WERE ADVANCED TO THE TARGET LESION TOGETHER WITH AN UNSPECIFIED GUIDING CATHETER. AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND DILATATION WAS PERFORMED. THE GW WAS REMOVED, AND THE BALLOON WAS DEFLATED; HOWEVER, FLUOROSCOPY SHOWED A PIECE OF COIL WAS CAUGHT IN THE TIP OF THE GUIDING CATHETER. THE GW WAS INSPECTED, AND IT WAS OBSERVED THAT A PIECE OF THE COIL WAS MISSING FROM THE TIP OF THE GW. NO RESISTANCE WAS FELT DURING ADVANCEMENT OR REMOVAL OF THE GW. THE DETACHED COIL WAS SNARED FROM THE TIP OF THE GUIDING CATHETER. THEN THE GUIDING CATHETER WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH UNSPECIFIED DEVICES. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONALLY, DEVICE ANALYSIS NOTED A SECOND POWERTURN FLEX GUIDE WIRE RETURNED WITH SCRAPPED TEFLON NOTED ON THE CORE. THE ACCOUNT CONFIRMED THAT THE SECOND POWERTURN FLEX WAS USED IN THE PROCEDURE AND THAT IT IS POSSIBLE THAT THE SCRAPPING HAPPENED IN THE PATIENT. THE WIRE WAS PL

  Patient problems: Foreign Body In Patient

  MAUDE report 8732519 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 50% STENOSED AND HEAVILY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A HT POWERTURN FLEX GUIDE WIRE WAS BEING ADVANCED THROUGH THE DISTAL RCA WHICH HAD A VERY SHARP TORTUOUS CURVE (APPROXIMATELY 150-DEGREE BEND). DURING THE INSERTION AND TRANSITION OF THIS CURVE, IT APPEARS THAT THE POWERTURN FLEX GUIDE WIRE PERFORATED THE DISTAL RCA. THIS WAS SEEN BY CONTRAST INJECTION AND MILD CONTRAST STAINING IN THE DISTAL RCA AREA. A 2.0 X 30MM TREK BALLOON DILATATION CATHETER WAS USED TO BALLOON THE PERFORATION FOR 5 MINUTES AND THEN TWO ADDITIONAL 15 MINUTE INTERVALS TO HELP WITH CLOTTING THE PERFORATED AREA. A MOBILE ECHO/ULTRASOUND CHECK WAS PERFORMED IN BETWEEN EACH INFLATION INTERVAL FOR PERICARDIAL EFFUSION AND NONE WAS NOTED. WHEN ALL APPEARED TO BE STABLE, THE PROCEDURE WAS ABORTED. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT FOR MONITORING AND IS IN STABLE CONDITION. THE PATIENT WILL NOT RECEIVE ANY MORE CORONARY INTERVENTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 8242431 ↗
• MalfunctionOct 29, 2018Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED ARTERY. DURING THE PROCEDURE, THE POWERTURN GUIDE WIRE GOT STUCK IN MICROCATHETER. A NEW GUIDE WIRE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS REVEALED THAT THE COIL WAS SEPARATED, 3.2 CM PROXIMAL TO THE CENTER SOLDER WITH THE CORE INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8016447 ↗
• InjuryOct 17, 2018Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A HT POWERTURN FLEX GUIDE WIRE WAS BEING ADVANCED; HOWEVER, THERE WAS DIFFICULTY MANEUVERING THE GUIDE WIRE AS IT COULD NOT BE DIRECTED INTO THE LAD. THE GUIDE WIRE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A SPORT GUIDE WIRE, UNSPECIFIED BALLOON CATHETER, AND UNSPECIFIED STENT. ABOUT TWO HOURS POST PROCEDURE THE PATIENT WAS HYPOTENSIVE. FLUIDS WERE ADMINISTERED AND AN ECHOCARDIOGRAM WAS PERFORMED WHICH SHOWED AN EFFUSION DUE TO A PERFORATION CAUSED BY THE HT POWERTURN FLEX GUIDE WIRE DISTAL TO THE LAD. PERICARDIOCENTESIS WAS PERFORMED; HOWEVER, UNSUCCESSFUL. MEDICATIONS WERE ADMINISTERED TO HELP INCREASE THE PATIENT'S BLOOD PRESSURE. PERICARDIOCENTESIS WAS PERFORMED TWO MORE TIMES, BUT FAILED. THE PATIENT WAS NOT STABLE AND WAS SENT TO SURGERY. THE PATIENT IS DOING WELL AFTER PERICARDIAL WINDOW SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Perforation

  MAUDE report 7976053 ↗