HI-TORQUE WHISPER 1011835HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648116117), received between Nov 3, 2016 and Jan 6, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SEVERELY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A WHISPER GUIDEWIRE WAS INSERTED BUT CAUSED A PERFORATION. THE PERFORATION WAS TREATED WITH BALLOON TAMPONADE TECHNIQUE. THE PROCEDURE WAS ABORTED. THE PATIENT WAS HOSPITALIZED. THE PHYSICIAN BELIEVED THE INTERACTION WITH THE HEAVY CALCIUM CAUSED THE PERFORATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 23975666 ↗
• InjuryJan 14, 2021Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY. DURING ADVANCEMENT OF A 014 WHISPER EXTRA SUPPORT GUIDE WIRE IT MET RESISTANCE WITH ANATOMY AND THE TIP SEPARATED. IT WAS ATTEMPTED TO SNARE THE TIP; HOWEVER, WAS UNSUCCESSFUL AND IT WAS DECIDED TO EMBED THE TIP INTO THE VESSEL. A COMMAND GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 11170833 ↗
• InjuryOct 28, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  ADDITIONAL INFORMATION WAS RECEIVED. THE TIP OF THE WHISPER GUIDE WIRE WAS THE AREA WHERE THE SEPARATION HAD OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244754 ↗
• MalfunctionApr 12, 2018Difficult To Position; Difficult to Remove; Physical Property Issue

  IT WAS REPORTED THAT THE GUIDE WIRE FELT VERY STICKY. IT WAS DIFFICULT TO ADVANCE AND RETRACT OTHER DEVICES OVER THE GUIDE WIRE. THE DEVICE WAS SUFFICIENTLY WETTED PRIOR TO USE AND IN BETWEEN DEVICES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7427055 ↗
• InjuryNov 3, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED LESIONS WITH MILD TORTUOSITY IN THE CIRCUMFLEX (CX) AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A WHISPER GUIDE WIRE WAS ADVANCED TOWARD THE TARGET LESION. ROTOBLATING WAS PERFORMED IN THE CX. AN UNSPECIFIED BALLOON WAS USED TO PREDILATE THE LESION. A 4X28MM XIENCE ALPINE STENT WAS ADVANCED TOWARD THE LESION AND SUCCESSFULLY DEPLOYED. ROTOBLATING WAS PERFORMED IN THE LAD. AN UNSPECIFIED BALLOON WAS USED TO PREDILATE THE LESION. A 3X23MM XIENCE ALPINE WAS ADVANCED TOWARD THE LESION AND SUCCESSFULLY DEPLOYED. NEAR THE END OF THE PROCEDURE A VERY DISTAL PERFORATION WAS NOTED. THE PERFORATION WAS NOT LOCATED NEAR THE ALPINE STENTS. THE PERFORATION HEALED ITSELF SO NO ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6077790 ↗