HI-TORQUE WHISPER 1005351HJRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE WHISPER LS Guide Wire .014 J Tip 3.0 cm x 190 cm · Class 2
All models of HI-TORQUE WHISPER (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648037757), received between Apr 27, 2022 and Apr 28, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (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
Device problems
- Material Separation2
- Difficult to Advance1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE WHISPER GUIDE WIRE WAS USED IN A PROCEDURE TO TREAT ATHEROSCLEROTIC LESIONS IN THE RIGHT CORONARY ARTERY (RCA) AND ACUTE MARGINAL (AM) ARTERIES WITH HEAVY CALCIFICATION. POST STENT IMPLANTATION, THE TIP OF THE WHISPER GW BROKE OFF IN THE RCA. A SNARE DEVICE WAS USED IN AN ATTEMPT TO REMOVE THE SEPARATED TIP WITHOUT SUCCESS; THEREFORE, A STENT WAS IMPLANTED TO EMBED THE GUIDE WIRE TIP AGAINST THE ARTERIAL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 16834578 ↗InjuryApr 27, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PATIENT'S KIDNEY. THE WHISPER GUIDE WIRE WAS ADVANCED TO THE LESION WHEN IT MET RESISTANCE WITH KIDNEY STONES AND THE TIP BROKE OFF. THE PATIENT WAS ALREADY SCHEDULED TO HAVE SURGERY FOR KIDNEY STONES THE NEXT DAY SO THE SEPARATED TIP WAS RETRIEVED VIA SNARE DURING THAT PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14226009 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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