HI-TORQUE WHISPER 1011834HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648116094), received between Nov 15, 2018 and May 5, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (5 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.

• MalfunctionMay 5, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE WHISPER GUIDE WIRE WAS ATTEMPTING TO ADVANCE AN NC TREK BALLOON DILATATION CATHETER (BDC) AND A DRUG ELUTING STENT; HOWEVER, THERE WAS RESISTANCE DURING ADVANCEMENT OVER THE GUIDE WIRE. THE WIRE IS NOTED TO BE STICKY AND THE COATING OF THE TIP OF THE WIRE WAS PEELING UPON REMOVAL OF THE WIRE. A NON-ABBOTT WIRE WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME NC TREK BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS 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 21960453 ↗
• MalfunctionFeb 20, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE WHISPER GUIDE WIRE WAS FOUND TO HAVE NO RADIOPACITY AT THE DISTAL END OF THE DEVICE. A NEW WHISPER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 21426341 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT DURING PROCEDURES OF GREATER COMPLEXITY, THE BALANCE MIDDLEWEIGHT (BMW), BMW UNIVERSAL II, BALANCE HEAVYWEIGHT, WHISPER MS AND WHISPER EXTRA SUPPORT GUIDE WIRES LOSE THEIR HYDROPHILICITY. THERE IS RESISTANCE WITH BALLOONS, STENTS AND IMAGING CATHETERS AND THE GUIDE WIRES ARE SIMPLY REMOVED WITH THE OTHER DEVICE AS A SINGLE UNIT BECAUSE THE DEVICES ARE STUCK TO EACH OTHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE LENGTH OF THE PROCEDURE IS EXTENDED AND THERE IS GREATER EXPOSURE TO X RAYS BUT THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145028 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT DURING PROCEDURES OF GREATER COMPLEXITY, THE BALANCE MIDDLEWEIGHT (BMW), BMW UNIVERSAL II, BALANCE HEAVYWEIGHT, WHISPER MS AND WHISPER EXTRA SUPPORT GUIDE WIRES LOSE THEIR HYDROPHILICITY. THERE IS RESISTANCE WITH BALLOONS, STENTS AND IMAGING CATHETERS AND THE GUIDE WIRES ARE SIMPLY REMOVED WITH THE OTHER DEVICE AS A SINGLE UNIT BECAUSE THE DEVICES ARE STUCK TO EACH OTHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE LENGTH OF THE PROCEDURE IS EXTENDED AND THERE IS GREATER EXPOSURE TO X RAYS BUT THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144789 ↗
• MalfunctionSep 28, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE ACCOUNT DISTRIBUTOR QUALITY REPRESENTATIVE, RECEIVED A HI-TORQUE WHISPER EXTRA SUPPORT GUIDE WIRE (GW), WITH A CUT IN THE INNER POUCH, COMPROMISING THE STERILITY OF THE DEVICE. THE GUIDE WIRE WAS NOT USED IN A PATIENT . THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544354 ↗
• MalfunctionFeb 28, 2020Break; Difficult to Remove; Material Separation; Difficult to Advance; Break; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY. AN UNSPECIFIED XIENCE ALPINE FAILED TO CROSS FOR AN UNKNOWN REASON. THEN A XIENCE XPEDITION FAILED TO CROSS DUE TO ANATOMY AND THE WHISPER GUIDE WIRE. AS THE XPEDITION WAS BEING REMOVED IT GOT STUCK ON THE WHISPER GUIDE WIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. ONCE OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE GUIDE WIRE HAD A FRACTURE. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED BY THE ACCOUNT SUBSEQUENT TO FILING THE INITIAL REPORT CONFIRMS THAT THE WHISPER GUIDE WIRE WAS BROKEN IN TWO PIECES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770384 ↗
• InjurySep 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE WHISPER GUIDE WIRE WAS INSERTED TO GO ACROSS THE STENT STRUTS OF A DEPLOYED STENT FOR A CRUSH TECHNIQUE IN THE DIAGONAL/LEFT ANTERIOR DESCENDING CORONARY ARTERY BIFURCATION. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT TO THE STENT. THE GUIDE WIRE REACHED THE BIFURCATION, BUT BEFORE IT REACHED THE STENT, IT WAS NOTED ON FLUORO THAT THE GUIDE WIRE HAD SEPARATED IN TWO PIECES. A BALLOON DILATATION CATHETER (BDC) WAS INSERTED PAST THE SEPARATED WIRE SEGMENT AND THE BDC WAS INFLATED. THE INFLATED BDC WAS ABLE TO PULL THE SEPARATED WIRE INTO THE GUIDE CATHETER. AT THAT POINT, ALL THE DEVICES WERE REMOVED FROM THE PATIENT AS A UNIT. A NEW WHISPER GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 9126505 ↗
• InjuryNov 15, 2018Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO BE PERFORMED WITH A 2.25 X 15 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) AND A 014 WHISPER SUPPORT GUIDE WIRE. THE SDS WAS ADVANCING OVER THE GUIDE WIRE, BUT COULD NOT CROSS THE TARGET LESION. REPORTEDLY, THE SDS FAILED TO POSITION DUE TO PROBABLE LUMEN OBSTRUCTION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE WHISPER GUIDE WIRE REVEALED THE POLYMER COATING WAS SEPARATED AND BUNCHED. ADDITIONALLY, IN THE GUIDE WIRE LUMEN OF THE XIENCE XPEDITION SDS THERE WAS A BLACK SUBSTANCE PRESENT SPORADICALLY THAT APPEARED TO BE MULTIPLE SEPARATED PIECES OF POLYMER COATING.

  Patient problems: Foreign Body In Patient

  MAUDE report 8075900 ↗