HI-TORQUE WHISPER 1005351HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648037740), received between Nov 21, 2016 and Feb 2, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionFeb 2, 2021Product Quality Problem; Material Too Soft/Flexible; Product Quality Problem; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED MID RIGHT CORONARY ARTERY. WHILE USING A WHISPER LS GUIDE WIRE, THE TIP OF THE WIRE WAS UNABLE TO BE MANIPULATED DUE TO THERMAL SAGGING [SEPARATION]. AN UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE REPORTED THERMAL SAGGING WAS A LACK OF SUPPORT AS THE TIP OF THE GUIDE WIRE WAS TOO SOFT OR FLEXIBLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267667 ↗
• MalfunctionDec 18, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX ARTERY. THE WHISPER LS GUIDE WIRE WAS ADVANCED INTO THE PATIENT ANATOMY AND CROSSED TO THE TARGET LESION. AN UNSPECIFIED INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS PLACED. DURING REMOVAL OF THE IVUS CATHETER, RESISTANCE WAS NOTED; HOWEVER, IT WAS UNKNOWN IF THE RESISTANCE WAS BETWEEN THE IVUS CATHETER AND THE PATIENT ANATOMY, OR WITH THE IVUS CATHETER AND THE GUIDE WIRE. FORCE WAS APPLIED TO REMOVE THE IVUS CATHETER AND THE GUIDE WIRE SEPARATED. THE IVUS CATHETER AND THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT AND ALL SEGMENTS OF THE SEPARATED GUIDE WIRE WERE REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11038237 ↗
• InjuryFeb 11, 2020Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX ARTERY. A 014 WHISPER GUIDE WIRE WAS ADVANCED TO THE LESION. AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE AND DILATED THREE TIMES FOR PRE-DILATATION. THE BALLOON CATHETER WAS REMOVED AND AN ATTEMPT TO ADVANCE AN UNSPECIFIED STENT SYSTEM WAS MADE, BUT THE STENT SYSTEM COULD NOT ADVANCE OVER THE GUIDE WIRE. THE STENT SYSTEM WAS REMOVED. AN ATTEMPT TO REMOVE THE GUIDE WIRE WAS MADE, BUT RESISTANCE WITH THE ANATOMY WAS FELT AND THE WIRE SUDDENLY SEPARATED. THE SEPARATED PIECE WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9694132 ↗
• MalfunctionNov 18, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT AN UNSPECIFIED BALLOON CATHETER WAS BEING BACKLOADED ON TO A 014 WHISPER LS GUIDE WIRE; HOWEVER, THEY BECAME STUCK. THE BALLOON CATHETER AND GUIDE WIRE HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW WHISPER LS 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 9338896 ↗
• MalfunctionNov 18, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  ADDITIONAL INFORMATION RECEIVED 11/25/2019 INDICATES THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MILDLY TORTUOUS DISTAL LEFT CIRCUMFLEX CORONARY ARTERY. THE PORTION OF THE GUIDE WIRE THAT WAS SEPARATED IS NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9338811 ↗
• MalfunctionNov 14, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO IMPLANT A CORONARY SINUS ELECTRODE. THE ELECTRODE IMPLANT COULD NOT BE ADVANCED OVER THE WHISPER GUIDE WIRE. THE DECISION WAS MADE TO REMOVE BOTH THE ELECTRODE AND GUIDE WIRE, BUT UPON REMOVAL IT WAS NOTED A PORTION OF THE GUIDE WIRE WAS MISSING. THE MISSING PORTION WAS RETRIEVED WHEN THE CORONARY SINUS INTRODUCER WAS REMOVED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9322668 ↗
• MalfunctionAug 20, 2018Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE ECCENTRIC, MILDLY TORTUOUS, HEAVILY CALCIFIED, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE WHISPER GUIDE WIRE MET RESISTANCE ADVANCING PAST THE LESION AND DID NOT APPEAR TO MOVE SMOOTHLY. THE GUIDE WIRE WAS REMOVED AND IT WAS NOTED THAT THE COATING WAS PEELED. A DIFFERENT WHISPER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799175 ↗
• MalfunctionNov 21, 2016Break; Stretched; Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS, MODERATELY CALCIFIED, 80% STENOSED, ECCENTRIC, DE NOVO, DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY A NON-ABBOTT GUIDE WIRE WAS PLACED AND A HT WHISPER GUIDE WIRE WAS ADVANCED TO A SIDE BRANCH AND MET ANATOMICAL RESISTANCE AND FAILED TO CROSS. THE WHISPER GUIDE WIRE WAS REMOVED AND OUTSIDE THE ANATOMY THE TIP WAS FLOPPY AND HAD LOSS SHAPE. A DIFFERENT DEVICE WAS USED IN THE PROCEDURE AND A XIENCE STENT WAS IMPLANTED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118539 ↗