THRUWAY™ M001492791Recalls & reported problems
Lake Region Medical · Class 2
All models of THRUWAY (5)
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 08714729405580), received between Feb 28, 2023 and Oct 28, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED 7 NOVEMBER 2024: 1. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. - GORE VIABAHN, BOSTON BALLOON BRAVUS. 2. WHEN DURING THE PROCEDURE DID THE EVENT OCCUR? DURING THE PROCEDURE. 3. WAS THE CATHETER STUCK/LOCKED ON THE GUIDEWIRE? OR WAS THERE JUST SIGNIFICANT RESISTANCE BETWEEN THE DEVICES (NOT STUCK)? N/A, THE DEVICE WAS NOT ABLE TO CROSS THE LESION. 4. WAS THE GUIDEWIRE ABLE TO BE REMOVED FROM THE CATHETER UPON REMOVAL FROM THE PATIENT? YES. 5. HOW WERE THE DEVICES REMOVED? THE DEVICE WAS ABLE TO BE REMOVED NORMALLY. 6. DID THE DAMAGE NOTED TO THE WIRE OCCUR POST PROCEDURE DURING HANDLING OR REMOVAL FROM THE CATHETER? N/A, THE DAMAGE NOTED TO THE WIRE IS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545774 ↗MalfunctionFeb 28, 2023Entrapment of Device; Entrapment of Device
PER CNF, IT WAS REPORTED THAT: SHAPING? YES A SFA CTO CASE REPORTED THAT THIS DEVICE GOT STUCK INSIDE THE BODY WITH A PROMINENT RAPTOR THAT WAS USED IN COMBINATION. WHEN THIS DEVICE WAS ATTEMPTED TO BE PULLED APART OUTSIDE THE BODY, THE SHAFT OF THIS DEVICE BENT, AND ITS USE WAS DISCONTINUED. IT IS SPECULATED THAT A THROMBUS MAY HAVE ATTACHED TO IT. ADDITIONAL INFORMATION RECEIVED FEBRUARY 27, 2023: 1. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC.? GUIDING SHEATH: MEDIKIT PARENT 60. 2. PLEASE PROVIDE THE MODEL AND SIZE OF THE "PROMINENT RAPTOR"? - LUMEN 0.018, LENGTH 135. 3. IT'S REPORTED, "WHEN THE DEVICE WAS ATTEMPTED TO BE PULLED APART OUTSIDE THE BODY, THE SHAFT OF THIS DEVICE BENT". A. WHICH DEVICE BENT, THE GUIDEWIRE OR CATHETER OR BOTH? THE GUIDEWIRE. THE CATHETER SEEMED TO STRETCHED SLIGHTLY. 4. WAS THE CATHETER STUCK/LOCKED ON THE GUIDEWIRE OR WAS THERE JUST SIGNIFICANT RESISTANCE BETWEEN THE DEVICES (NOT STUCK)? THERE WAS SIGNIFICANT RESISTANCE BETWEEN THE DEVICES. 5. HOW WERE THE DEVICES REMOVED FROM THE PATIENT? BOTH THE PROMINENT RAPTOR AND THE GUIDEWIRE WERE TAKEN OUT OF THE BODY, AND THEY WERE TRYING TO BE SE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16455155 ↗
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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