HI-TORQUE FLOPPY 22299MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648079696), received between Oct 17, 2016 and Mar 2, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2021Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT DURING A COMPLEX HEAVILY CALCIFIED MID-RIGHT CORONARY ARTERY INTERVENTION AFTER THE LESION WAS STENTED, ADDITIONAL LESIONS WERE NOTED DISTAL TO THE STENT. A HI TORQUE FLOPPY II EXTRA SUPPORT GUIDE WIRE (GW) WAS ADVANCED DISTALLY AND A BALLOON CATHETER WAS ADVANCED OVER THE WIRE TO DILATE THE DISTAL LESION. AFTER REMOVAL OF THE GW THROUGH THE BLEEDBACK VALVE, THE GW APPEARED TO HAVE SHEARED/UNRAVELED FROM THE PROXIMAL PART TO THE SOFT TIP OF THE WIRE. ALL DEVICES WERE REMOVED AT THAT TIME. NOTHING WAS LEFT IN THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11402576 ↗
• InjuryOct 17, 2016Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS OBTUSE MARGINAL (OM) ARTERY. A HT FLOPPY ES GUIDE WIRE WAS USED DURING A PROCEDURE WHERE AN INTERVENTION WAS SUCCESSFULLY PERFORMED. AT THE END OF THE PROCEDURE WHEN THE DEVICES WERE REMOVED FROM THE ANATOMY, IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE HAD SEPARATED AND REMAINED IN THE OM. THERE WAS NO REPORTED RESISTANCE ADVANCING OR REMOVING THE GUIDE WIRE. ATTEMPTS WERE MADE TO REMOVE THE TIP WITH A SNARE DEVICE BUT IT COULD NOT BE REMOVED AND REMAINS IN THE OM. THE PROCEDURE WAS COMPLETED AT THIS TIME WITHOUT ADDITIONAL TREATMENT. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE ATTEMPTS TO REMOVE THE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6035322 ↗