HI-TORQUE WHISPERRecalls & reported problems across all models

We found 11 models of HI-TORQUE WHISPER by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 172 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2016 and Sep 29, 2026 — classified as 4 deaths, 91 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Material Separation” (73 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HI-TORQUE WHISPER problems

HI-TORQUE WHISPER models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HI-TORQUE WHISPER 1005357H

  WIRE, GUIDE, CATHETER
  1 death55 reports
• HI-TORQUE WHISPER 1005357HJ

  WIRE, GUIDE, CATHETER
  2 deaths38 reports
• HI-TORQUE WHISPER 1011834H

  WIRE, GUIDE, CATHETER
  1 death35 reports
• HI-TORQUE WHISPER 1005359H

  WIRE, GUIDE, CATHETER
  11 reports
• HI-TORQUE WHISPER 1005351H

  WIRE, GUIDE, CATHETER
  8 reports
• HI-TORQUE WHISPER 1011834HJ

  WIRE, GUIDE, CATHETER
  8 reports
• HI-TORQUE WHISPER 1005359HJ

  WIRE, GUIDE, CATHETER
  7 reports
• HI-TORQUE WHISPER 1011835H

  WIRE, GUIDE, CATHETER
  5 reports
• HI-TORQUE WHISPER 1005351HJ

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE WHISPER 1011835HJ

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE WHISPER 1005353H

  WIRE, GUIDE, CATHETER
  1 report

Recent HI-TORQUE WHISPER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Remove; Material Separation

  It was reported that the procedure was to treat the mid left anterior descending (mLAD) artery. The Whisper guide wire (GW) was being used in the procedure with a non-Abbott imaging catheter. Resistance occurred when attempting to remove the imaging catheter from the Whisper GW and the GW separated in half. Both parts of the GW were simply removed with the imaging catheter as a single unit. Another Whisper GW was used to continue the procedure. There was no adverse patient effect. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927336 ↗
• InjuryAug 28, 2026Material Separation

  It was reported that the procedure performed was a pulmonary valve perforation followed by pulmonary valvuloplasty. The 014 HT Whisper guide wire was positioned in the distal branch of the pulmonary artery. The guide wire was rotated clockwise to achieve and maintain stability. The guide wire was subsequently untwisted by counterclockwise rotation for removal. During advancement of the microcatheter over the guide wire, the guide wire tip detached and was retained within a distal branch of the right pulmonary artery. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50502968 ↗
• InjuryAug 27, 2026Material Separation

  It was reported the procedure was to perform electrophysiology in the coronary artery. The Whisper MS guide wire was used in the patient however after the guide wire was removed, fluoroscopy confirmed that a portion of the guide wire remained in the patient. Several attempts were made to retrieve the separated portion with partial success. A small fragment migrated to the distal pulmonary artery and was determined to be too far to retrieve therefore it was left in the patient. Per the physician, the remaining portion was not expected to cause clinical issues for the patient. A delay in the procedure was reported. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50472762 ↗
• InjuryJul 17, 2026Difficult to Remove; Failure to Advance; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A STENOSED, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS 100% STENOSED. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS OF PREVIOUSLY IMPLANTED UNSPECIFIED STENTS THROUGH SFA. A NON-ABBOTT GUIDE WIRE WAS USED ALONGSIDE THE 014 WHISPER MS GUIDE WIRE AS A BUDDY WIRE. DURING ADVANCEMENT, THE WHISPER GUIDE WIRE MET RESISTANCE WITH THE PREVIOUSLY IMPLANTED STENTS AND COULD NOT CROSS. DURING REMOVAL, THE WHISPER GUIDE WIRE MET RESISTANCE WITH THE IMPLANTED STENTS, LEADING TO PROXIMAL RETRACTION OF THE STENT. AS A RESULT, THE STENTS NO LONGER OVERLAPPED APPROPRIATELY, LEAVING A GAP BETWEEN THEM. AN ADDITIONAL UNSPECIFIED STENT WAS IMPLANTED TO BRIDGE THE GAP. A 5.0X20MM ARMADA 35 BALLOON WAS INSERTED OVER THE NON-ABBOTT GUIDE WIRE AND INFLATED TO HOLD THE STENT IN PLACE. ONCE INFLATED AND STENT WAS STABILIZED, THE WHISPER GUIDE WIRE WAS ABLE TO BE REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25860308 ↗
• InjuryJul 9, 2026Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE WHISPER MS GUIDE WIRE WAS ADVANCED HOWEVER LOST ACCESS FIVE TIMES AND DURING REMOVAL RESISTANCE WAS NOTED. THE GUIDE WIRE SEPARATED AND WAS FLOATING IN THE PROXIMAL RCA. THE SEPARATED PORTION WAS UNABLE TO BE SNARED THEREFORE THE PATIENT WILL BE SENT FOR SURGERY TO REMOVE THE SEPARATED PORTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25763842 ↗
• MalfunctionFeb 27, 2026Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA) AND HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN IMPELLA HEART PUMP WAS PLACED ALONG WITH A TEMPORARY VENOUS PACEMAKER. AN EBU 3.5 GUIDE CATHETER WAS INSERTED INTO THE LEFT MAIN (LM) ARTERY AND THEN A NON-ABBOTT BLACK WIRE WAS INSERTED INTO THE PROXIMAL LAD. A TURNPIKE WAS INSERTED OVER THE BLACK WIRE TRYING TO CROSS THE RIGHT LESION IN THE MID LAD. THE WIRE WAS EXCHANGED FOR AN EXTRA SUPPORT WHISPER WIRE HOWEVER IT FAILED TO CROSS THE LESION AND WAS REMOVED. A SECOND WHISPER GUIDE WIRE WAS INSERTED HOWEVER FAILED TO CROSS THE LESION AND WAS REMOVED. WHEN TAKING AN ANGIOGRAM A PERFORATION WAS NOTED. PER THE PHYSICIAN, THE SECOND WHISPER GUIDE WIRE WAS TOO AGGRESSIVE FOR THE LESION; RESULTING IN THE PERFORATION. THE DECISION WAS MADE TO WATCH THE PATIENT WHO WAS HEMODYNAMICALLY STABLE. THE PROCEDURE WAS ABORTED TO LET THE PERFORATION HEAL. PATIENT THEN HAD TO HAVE A PERICARDIOCENTESIS TO REMOVE FLUID FROM THE PERICARDIUM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469004 ↗
• InjuryFeb 27, 2026Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA) AND HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN IMPELLA HEART PUMP WAS PLACED ALONG WITH A TEMPORARY VENOUS PACEMAKER. AN EBU 3.5 GUIDE CATHETER WAS INSERTED INTO THE LEFT MAIN (LM) ARTERY AND THEN A NON-ABBOTT BLACK WIRE WAS INSERTED INTO THE PROXIMAL LAD. A TURNPIKE WAS INSERTED OVER THE BLACK WIRE TRYING TO CROSS THE RIGHT LESION IN THE MID LAD. THE WIRE WAS EXCHANGED FOR AN EXTRA SUPPORT WHISPER WIRE HOWEVER IT FAILED TO CROSS THE LESION AND WAS REMOVED. A SECOND WHISPER GUIDE WIRE WAS INSERTED HOWEVER FAILED TO CROSS THE LESION AND WAS REMOVED. WHEN TAKING AN ANGIOGRAM A PERFORATION WAS NOTED. PER THE PHYSICIAN, THE SECOND WHISPER GUIDE WIRE WAS TOO AGGRESSIVE FOR THE LESION; RESULTING IN THE PERFORATION. THE DECISION WAS MADE TO WATCH THE PATIENT WHO WAS HEMODYNAMICALLY STABLE. THE PROCEDURE WAS ABORTED TO LET THE PERFORATION HEAL. PATIENT THEN HAD TO HAVE A PERICARDIOCENTESIS TO REMOVE FLUID FROM THE PERICARDIUM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 24468962 ↗
• 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 ↗
• InjuryDec 3, 2025Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT RADIAL ARTERY. THE WHISPER GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED BUT THERE WAS INTENSE RESISTANCE AND IT WAS IMPOSSIBLE TO ADVANCE THE CATHETER AND MANIPULATE THE GUIDE WIRE. THE WHISPER GUIDE WIRE WAS REMOVED WITH THE AID OF THE INTRODUCER DILATOR HOWEVER THERE WAS SIGNIFICANT RESISTANCE AND THE WIRE SEPARATED. A SNARE WAS ATTEMPTED BUT THE WIRE CONTINUED TO BREAK APART. AT THAT TIME, THE ATTEMPTS WERE STOPPED AND THE VASCULAR SURGERY TEAM PERFORMED REMOVAL THROUGH A CUT DOWN OF THE BRACHIAL ARTERY. THE PATIENT UNDERWENT A SURGICAL PROCEDURE UNDER GENERAL ANESTHESIA, WITH AN APPROXIMATELY 10-CENTIMETER INCISION IN THE ARM TO COMPLETELY REMOVE THE FRAGMENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708532 ↗
• InjuryOct 22, 2025Deformation Due to Compressive Stress; Device Damaged by Another Device; Difficult to Advance; Deformation Due to Compressive Stress; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A BIFURCATION IN THE MAIN BRANCH. THE WHISPER GUIDE WIRE WAS ADVANCED TO THE SIDE BRANCH HOWEVER RESISTANCE WAS MET WITH THE PREVIOUSLY IMPLANTED STENT, CAUSING DAMAGE TO THE IMPLANTED STENT. THE WHISPER GUIDE WIRE WAS REMOVED IN ONE PIECE AND A KINK WAS NOTED AT THE TIP. ADDITIONAL INTERVENTION WAS PERFORMED WITH MULTIPLE BALLOONS AND STENT IMPLANTATION AS TREATMENT FOR DAMAGE TO THE IMPLANTED STENT; CAUSING A DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356469 ↗
• MalfunctionAug 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE WHISPER MS GUIDEWIRE WAS POSITIONED IN THE CX ARTERY AND ANOTHER WHISPER MS GUIDEWIRE WAS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH GUIDEWIRES WERE NOTED TO MOVE TOGETHER AS IF BEING PULLED SIMULTANEOUSLY DUE TO STICKING WHEN ONLY ONE GUIDEWIRE IS BEING RETRACTED. THE GUIDEWIRE WAS STILL REMOVED INDEPENDENTLY AND USED SUCCESSFULLY. AN NC TREK NEO BALLOON WAS ADVANCED AND INFLATED SUCCESSFULLY; HOWEVER, DURING A SECOND INFLATION ATTEMPT TO USE THE BALLOON AT THE BIFURCATION, THE BALLOON WAS UNABLE TO RE-CROSS THE VESSEL/STENT DUE TO THE CROSSING PROFILE OF THE BALLOON. A NEW BALLOON HAD TO BE OPENED TO COMPLETE THE PROCEDURE. 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 22867420 ↗
• MalfunctionAug 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE WHISPER MS GUIDEWIRE WAS POSITIONED IN THE CX ARTERY AND ANOTHER WHISPER MS GUIDEWIRE WAS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH GUIDEWIRES WERE NOTED TO MOVE TOGETHER AS IF BEING PULLED SIMULTANEOUSLY DUE TO STICKING WHEN ONLY ONE GUIDEWIRE IS BEING RETRACTED. THE GUIDEWIRE WAS STILL REMOVED INDEPENDENTLY AND USED SUCCESSFULLY. AN NC TREK NEO BALLOON WAS ADVANCED AND INFLATED SUCCESSFULLY; HOWEVER, DURING A SECOND INFLATION ATTEMPT TO USE THE BALLOON AT THE BIFURCATION, THE BALLOON WAS UNABLE TO RE-CROSS THE VESSEL/STENT DUE TO THE CROSSING PROFILE OF THE BALLOON. A NEW BALLOON HAD TO BE OPENED TO COMPLETE THE PROCEDURE. 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 22862116 ↗
• MalfunctionJun 25, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE WHISPER GUIDE WIRE WAS ADVANCED WITH AN IVUS DEVICE; HOWEVER, ON THE LAST RUN, THE GUIDE WIRE FRACTURED AND BECAME STUCK INSIDE THE IVUS CATHETER. THE IVUS CATHETER WAS WITHDRAWN WITH THE SEPARATED GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326842 ↗
• MalfunctionMay 28, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT WHEN ATTEMPTING TO ADVANCE UNSPECIFIED BALLOON CATHETER AND UNSPECIFIED STENT DELIVERY SYSTEM THE DEVICES GET STUCK WITH THE .014 WHISPER GUIDE WIRE. THE DEVICES CANNOT MOVE FORWARD. THEREFORE, AN UNSPECIFIED GUIDE WIRE IS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED THAT A .014 WHISPER EXTRA SUPPORT GUIDE WIRE AND A .014 WHISPER MS GUIDE WIRE MET RESISTANCE WITH THE BALLOON CATHETER AND STENT DELIVERY SYSTEM AND WOULD GET STUCK. HOWEVER, IT IS UNKNOWN WHICH SPECIFIC GUIDE WIRE BECAME STUCK WITH THE BALLOON OR STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097469 ↗
• MalfunctionMay 19, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT UPON OPENING THE WHISPER GUIDE WIRE, THE DEVICE WAS NOTED TO BE BROKEN/BENT. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046589 ↗

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