HI-TORQUE WHISPER 1011835HJRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE WHISPER ES Guide Wire .014 J Tip 3.0 cm x 300 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 08717648116124), received between Nov 8, 2017 and Jan 18, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Material Separation1
- Off-Label Use1
Patient problems
- No Consequences Or Impact To Patient1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 18, 2021Off-Label Use; Material Separation; Off-Label Use; Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) TO THE TIBIAL POSTERIOR ARTERY. THE WHISPER WIRE WAS USED DURING THE PROCEDURE. THE PHYSICIAN ADVANCED AN ASPIRATION CATHETER OVER THE GUIDE WIRE TO ASPIRATE A PRE-EXISTING THROMBUS. THE ASPIRATION CATHETER WAS PULLED TO REMOVE AND NO RESISTANCE WAS NOTED; HOWEVER, IT WAS NOTED AFTER REMOVAL OF THE ASPIRATION CATHETER THAT THE GUIDE WIRE HAD SEPARATED IN THE PATIENT ANATOMY. A SNARE DEVICE WAS ADVANCED AND WAS ABLE TO RETRIEVE ALL PORTIONS OF THE SEPARATED GUIDE WIRE. NO PORTION OF THE GUIDE WIRE REMAINED IN THE PATIENT ANATOMY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11190083 ↗InjuryNov 8, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE WHISPER ES (EXTRA SUPPORT) GUIDE WIRE WAS ADVANCED INTO THE CHRONIC TOTAL OCCLUSION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). AFTER FOUR NON-ABBOTT STENTS WERE IMPLANTED IN THE RCA, A LOCALIZED, GUIDE WIRE PERFORATION IN THE DISTAL RCA WAS NOTED. A 2.8X16 MM GRAFTMASTER STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Perforation
MAUDE report 7012136 ↗
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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