HI-TORQUE FLOPPY 22339M-901Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648080111), received between May 2, 2018 and Sep 3, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• InjurySep 3, 2021Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE DISTAL TIP OF A .014 HI-TORQUE FLOPPY II GUIDE WIRE FRAYED WHEN TRYING TO WITHDRAW THE GUIDE WIRE. IT FELT LIKE THE TIP OF THE GUIDE WIRE WAS HUNG UP ON THE END OF THE NEEDLE. MANEUVERS TO DISENGAGE THE GUIDE WIRE FROM END OF NEEDLE DID NOT HELP. AN ATTEMPT TO REMOVE THE NEEDLE AND WIRE TOGETHER WAS MADE BUT THE WIRE REMAINED HUNG UP DESPITE THE NEEDLE BEING REMOVED. MILD TENSION WAS PLACED ON THE GUIDE WIRE; HOWEVER, THE WIRE FRAYED FROM THE DISTAL END, LEAVING A SMALL HAIRLIKE WIRE FROM THE TIP OF THE WIRE EXTENDING INTO THE PATIENT'S GROIN. THE SMALL WIRE WAS SECURED WITH HEMOSTATS AND WITH MILD TENSION THE WIRE DISLODGED. A FINAL VIEW OF THE ABDOMEN AND LATERAL VIEW OF RIGHT GROIN/ABDOMEN SHOWED A RETAINED WIRE FRAGMENT. IT WAS DISCUSSED TO REMOVE THE ADDITIONAL PIECE OF THE WIRE IN THE PATIENT, BUT IT WAS DECIDED THAT IT WAS TOO SMALL OF A PIECE TO LOCATE AND THE RISK OF HARM OUTWEIGHED THE BENEFIT. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 12425496 ↗
• MalfunctionMay 2, 2018Detachment Of Device Component; Kinked

  IT WAS REPORTED THAT BEFORE USE, WHEN THE HIGH-TORQUE (HT) FLOPPY II GUIDE WIRE WAS UNPACKAGED, THE GUIDE WIRE TIP WAS BENT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW HT FLOPPY II GUIDE WIRE WAS USED FROM A DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THE SHAPING RIBBON WAS DETACHED.

  Patient problems: No Patient Involvement

  MAUDE report 7479602 ↗