HI-TORQUE WHISPER 1005359HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648037825), received between Jan 23, 2017 and Jul 17, 2026 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 THE IVUS CATHETER WAS WITHDRAWN WITH THE SEPARATED GUIDE WIRE.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 ↗
• InjuryFeb 7, 2022Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT ON (B)(6) 2022, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT ANTERIOR TIBIAL (AT) WITH A CHRONIC TOTAL OCCLUSION AND NO BLOOD FLOW. THE WHISPER GUIDE WIRE FAILED TO CROSS THE CTO LESION. DURING REMOVAL, THE DEVICE WAS STUCK IN THE CALCIFICATION AND THE POLYMER JACKET SEPARATED FROM THE DEVICE. IT WAS DECIDED TO LEAVE THE SEPARATED PORTION IN THE CALCIFICATION WITHOUT ANY ADDITIONAL TREATMENT/INTERVENTION PERFORMED TO REMOVE THE SEPARATED PORTION. ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13472517 ↗
• MalfunctionSep 29, 2020Break; Device Difficult to Setup or Prepare; Stretched; Deformation Due to Compressive Stress; Break; Device Difficult to Setup or Prepare; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT AFTER REMOVING THE WHISPER GUIDE WIRE FROM THE PACKAGING, A BEND WAS NOTED. THE PHYSICIAN ATTEMPTED TO SHAPE THE GUIDE WIRE BUT THE COILS APPEARED TO UNRAVEL. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW WHISPER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10601558 ↗
• InjuryJun 23, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND OCCLUDED LESION IN THE ANTERIOR TIBIAL (AT) ARTERY. A 014 HT WHISPER GUIDE WIRE WAS BEING ADVANCED TO THE LESION THROUGH A CROSSING CATHETER; HOWEVER, IT FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE GUIDE WIRE WAS REMOVED AND IT WAS NOTED THAT THE TIP HAD SEPARATED. THE PHYSICIAN BELIEVES HE WAS IN A COLLATERAL VESSEL WHEN THE GUIDE WIRE WAS REMOVED AND THE TIP REMAINED IN THE PATIENT. NO ATTEMPT WAS MADE TO REMOVE THE SEPARATED TIP AS IT IS NOT FREE-FLOATING, AND IT REMAINS IN THE AT ARTERY OR COLLATERAL. THE PROCEDURE WAS COMPLETED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10186927 ↗
• InjuryMay 11, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: PATIENT CAME INTO HOSPITAL FOR URGENT LIMB SALVAGE CASE FOUND TO HAVE IN STENT RE-STENOSIS IN COMMON FEMORAL ARTERY. THE ENTRY WAS MADE ON THE RIGHT SIDE WITH A CROSS OVER THE LEFT COMMON FEMORAL / ILIAC ARTERY WHERE THE EXISTING STENT WAS OCCLUDED. AT THE END OF THE PROCEDURE WHEN ATTEMPT WAS MADE TO REMOVE THE WIRE AND THE SUPPORTING CATHETER THE WIRE WOULD NOT RELEASE FROM ITS POSITION. AN ATTEMPT WAS MADE TO PLACE THE CATHETER OVER THE WIRE AND PULL BACK THE SYSTEM BUT THIS WAS ALSO UNSUCCESSFUL. AFTER SEVERAL ATTEMPTS WERE MADE THE WIRE AND CATHETER RELEASED. IT WAS NOTED BY THE SCRUB TECH THAT THE END OF THE WIRE HAD BROKEN OFF AND UNDER FLUOROSCOPY WAS NOTED TO BE RETAINED IN THE VESSEL NOTED ABOVE. THE DOCTOR WAS MADE AWARE. NO ATTEMPT AT RETRIEVAL WAS MADE AT THAT TIME. FDA SAFETY REPORT ID# (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10045539 ↗
• MalfunctionSep 13, 2018Off-Label Use; Material Separation; Off-Label Use; Material Separation

  IT WAS REPORTED THAT AT THE END OF AN ELECTROPHYSIOLOGY CASE, THE LEAD WAS BEING PULLED OUT WHEN A 014 WHISPER GUIDE WIRE (GW) BROKE INTO TWO PIECES. IT WAS DECIDED THAT THE ENTIRE SYSTEM BE SIMPLY PULLED OUT ALTOGETHER AS A SINGLE UNIT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE GW. THE PATIENT IS FINE. 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 7873379 ↗
• InjuryAug 31, 2018Material Separation; Material Separation

  IT WAS REPORTED THE PATIENT ADMITTED WITH CHEST PAIN ON (B)(6) 2018. PATIENT WAS TAKEN FOR CARDIAC CATHETERIZATION ON (B)(6) 2018 AND WAS FOUND TO HAVE MULTIVESSEL CORONARY ARTERY DISEASE. THE PATIENT WAS DEEMED NOT TO BE A GOOD CANDIDATE FOR BYPASS SURGERY; PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH STENTING TO THE LEFT ANTERIOR DESCENDING (LAD) WAS DONE ON (B)(6) 2018 AND RETURNED TO THE CATH LAB ON (B)(6) 2018 FOR INTERVENTION IN THE OBTUSE MARGINAL (OM) AND CIRCUMFLEX (CX) BRANCHES. DURING THE PROCEDURE WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A STENT TO THE OM BRANCH, THE WHISPER WIRE FRACTURED AND BROKE OFF IN THE CX MARGINAL BRANCH. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FRACTURED WIRE DURING WHICH THE PATIENT DEVELOPED THROMBOSIS OF THE LEFT CIRCUMFLEX WITH DISSECTION. PATIENT WAS TRANSFERRED TO MEMORIAL REGIONAL HOSPITAL FOR EVALUATION BY CARDIOTHORACIC SURGERY TO DETERMINE IF FURTHER ATTEMPTS AT RETRIEVAL OF THE WIRE FRAGMENT WOULD BE DONE OR CARDIAC SURGERY. OPEN HEART SURGERY WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection; Thrombosis

  MAUDE report 7839489 ↗
• InjuryMar 30, 2018Detachment Of Device Component

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION WITH HEAVY CALCIFICATION IN A PERONEAL ARTERY. THE WHISPER GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE AND ATHERECTOMY WAS PERFORMED. DURING THE PROCEDURE THE DISTAL TIP SEPARATED IN THE VESSEL. A SNARE DEVICE WAS NOT USED DUE TO THE VESSEL BEING NARROW AND THE SNARE NOT HAVING ENOUGH ROOM TO OPEN. A CATHETER WAS ADVANCED IN ATTEMPT TO ASPIRATE THE SEPARATED PORTION BUT WAS UNSUCCESSFUL. THE SEPARATED PORTION REMAINS EMBEDDED IN THE VESSEL. THE PATIENT WAS STABLE WITH NO PAIN OR DISCOMFORT. THE PATIENT IS SCHEDULED TO RETURN FOR ULTRASOUND DOPPLER TO BE REASSESSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7387298 ↗
• InjuryOct 26, 2017Detachment Of Device Component; Difficult To Position; Physical Resistance

  IT WAS REPORTED THIS WAS A LIMB SALVAGE CASE. THE PROCEDURE WAS PERFORMED TO TREAT A 99% OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE WHISPER GUIDE WIRE AND 2.0 X 20 MM MINI TREK OTW BALLOON DILATATION CATHETER (BDC) WERE ADVANCED TO THE LESION. THE WHISPER GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED FURTHER, BUT RESISTANCE WAS FELT WITH THE MINI TREK BDC AND THE CALCIFICATION, AND THE TIP OF THE GUIDE WIRE BROKE IN THE VESSEL. THE MINI TREK AND WHISPER WERE REMOVED WITHOUT ISSUE. AN UN-SPECIFIED GUIDE WIRE AND BDC WERE THEN ADVANCED SUCCESSFULLY. THE SEPARATED TIP OF THE WHISPER GUIDE WIRE WAS CRUSHED AGAINST THE VESSEL WALL, AND THE TARGET LESION WAS SUCCESSFULLY DILATED. THE PATIENT HAD GOOD FLOW AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6979884 ↗
• MalfunctionJan 23, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING USE, THE WHISPER GUIDE WIRE TIP BECAME DETACHED WHILE IN THE PATIENT ANATOMY. THE TIP WAS RETRIEVED USING A SNARE AND ALL WAS REMOVED FROM THE ANATOMY IN 2 PIECES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6270118 ↗