HI-TORQUE CONNECT 1012594Recalls & reported problems
Abbott Vascular Inc. · Hi-Torque Connect 250T Guide Wire .018" 195 cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648175046), received between Jun 20, 2022 and Jun 27, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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 16, 2026.
Most reported problems
Device problems
- Difficult to Advance2
- Failure to Advance2
Patient problems
- Vascular Dissection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2022Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THIS WAS A VERY DIFFICULT CASE AND THE THROMBOSED AREA WAS VERY CRUSTY. DURING USE, TWO CONNECT GUIDE WIRES EXPERIENCED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. BOTH GUIDE WIRES SEPARATED AND FRAYED AND BROKE OFF AND THERE WAS ALSO RESISTANCE DURING REMOVAL OF BOTH GUIDE WIRES. THE SECOND GUIDE WIRE LIKELY HAD THE TIP CAUGHT ON CALCIFIED PLAQUE. THE SEPARATED PORTIONS WERE RETRIEVED AND NOTHING REMAINED IN THE PATIENT. DURING PREPARATION OF THE ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, A LEAK WAS SUSPECTED AS THERE WAS AIR GOING INTO THE SYRINGE WHEN PULLING THE SYRINGE BACK TO FILL WITH CONTRAST. ANOTHER ARMADA 14 PTA CATHETER WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, THE LESION COULD NOT BE TREATED DUE TO A FAILURE TO CROSS OF AN UNSPECIFIED DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Vascular Dissection
MAUDE report 14826577 ↗MalfunctionJun 20, 2022Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THIS WAS A VERY DIFFICULT CASE AND THE THROMBOSED AREA WAS VERY CRUSTY. DURING USE, TWO CONNECT GUIDE WIRES EXPERIENCED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. BOTH GUIDE WIRES SEPARATED AND FRAYED AND BROKE OFF AND THERE WAS ALSO RESISTANCE DURING REMOVAL OF BOTH GUIDE WIRES. THE SECOND GUIDE WIRE LIKELY HAD THE TIP CAUGHT ON CALCIFIED PLAQUE. THE SEPARATED PORTIONS WERE RETRIEVED AND NOTHING REMAINED IN THE PATIENT. DURING PREPARATION OF THE ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, A LEAK WAS SUSPECTED AS THERE WAS AIR GOING INTO THE SYRINGE WHEN PULLING THE SYRINGE BACK TO FILL WITH CONTRAST. ANOTHER ARMADA 14 PTA CATHETER WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, THE LESION COULD NOT BE TREATED DUE TO A FAILURE TO CROSS OF AN UNSPECIFIED DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Vascular Dissection
MAUDE report 14743104 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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