HI-TORQUE CONNECT 1012595Recalls & reported problems
Abbott Vascular Inc. · Hi-Torque Connect 250T Guide Wire .018" 300 cm · Class 2
Data updated Oct 18, 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 08717648175053), received between Jun 24, 2020 and Oct 25, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Stretched2
- Difficult to Advance1
- Difficult to Remove1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2021Break; Stretched; Failure to Advance; Break; Stretched; Failure to Advance
IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A RIGHT COMMON ILIAC ARTERY WITH CHRONIC TOTAL OCCLUSION. A RETROGRADE APPROACHED WAS TO BE PERFORMED. AN HT CONNECT 250T GUIDEWIRE (GW) WAS ADVANCING, BUT COULD NOT CROSS THE TARGET LESION DUE TO ANATOMICAL CHALLENGES. THEN, APPROXIMATELY 5CM FROM THE DISTAL TIP, A CORE BREAK WAS OBSERVED. THE COILS SEEMED TO HAVE UNRAVELED. THEREFORE, THE GW WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED GW AND A DIFFERENT APPROACH. 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 12689181 ↗MalfunctionJun 24, 2020Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance
SUBSEQUENT INFORMATION IDENTIFIED THAT THE INITIAL REPORTS WERE FILED BY ABBOTT VASCULAR INADVERTENTLY. THE CONNECT GUIDE WIRE IS A LAKE REGION DEVICE; THEREFORE, LAKE REGION IS RESPONSIBLE FOR POST MARKET SURVEILLANCE AND REPORTABILITY. LAKE REGION WERE NOTIFIED AND WILL FILE SEPARATE REPORTS ACCORDINGLY TO CAPTURE THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10189952 ↗
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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