THRUWAY™ M001492831Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729405627), received between Feb 24, 2021 and Jan 23, 2025 — classified as 1 injury, 1 malfunction.
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
- Flaked1
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
InjuryJan 23, 2025Break; Break
EVENT DESCRIPTION: TRIED TO ADVANCE AND DEPLOY STENT AND WIRE BECAME WRAPPED AND BROKE OFF WITH PART OF THE STENT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? SNARED OUT THE PIECES. WHAT IS THE NEXT COURSE OF ACTION?: UNKNOWN. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: OTHER. PROVIDE DETAILS FOR "OTHER" PATIENT COMPLICATION: SNARE NEEDED. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: UNKNOWN. MEDICAL OR SURGICAL INTERVENTIONS: SNARED OUT PIECE OF STENT AND WIRE PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN. PATIENT OUTCOME: UNKNOWN. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. QUESTION: HOW WAS THE DEVICE REMOVED FROM THE PATIENT (I.E. PULLED, SNARED, ETC)? ANSWER: SNARED. QUESTION: WAS THE DEVICE REMOVED FROM THE PATIENT IN ONE PIECE? ANSWER: UNKNOWN. PHOTO OR VIDEO OF ISSUE: NO. PROCUDURE WAS COMPLETED USING AN ALTERNATIVE METHOD/DEVICE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21217014 ↗MalfunctionFeb 24, 2021Entrapment of Device; Flaked; Material Integrity Problem; Entrapment of Device; Flaked; Material Integrity Problem
THE LESION WAS ABLE TO CROSS WITH A THRUWAY IN A CROSSOVER APPROACH FOR AN SFA CASE AND PRE-DILATION WAS PERFORMED WITH A 4MM AND THEN THE DEVICE WAS DELIVERED SINCE POST-DILATION WAS PERFORMED WITH A STERLING AFTER AN ELUVIA 6MM 120MM AND 7MM 120MM WERE PLACED, BUT THE RESISTANCE BECAME SEVERE WHEN THE BALLOON STARTED TO COME OUT FROM THE TIP OF THE PARENT, AND IT COULD NOT BE DELIVERED SMOOTHLY INTO THE STENT. DELIVERY WAS PERFORMED WHILE RESISTANCE WAS FELT IN THE STENT AND INFLATION OF THE BALLOON WAS PERFORMED ABOUT 3 TIMES AND THE BALLOON WAS TRIED TO BE REMOVED, BUT THE BALLOON GOT STUCK WITH THE GUIDE WIRE AND IT COULD NOT BE REMOVED, SO IT WAS REMOVED AS A SET WITH THE GUIDEWIRE. AFTER THAT, IMAGING WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11372912 ↗
Other Wire, Guide, Catheter devices
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- 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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