InQwire® 00884450011133Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of InQwire (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450011133), received between Mar 9, 2020 and Jan 6, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Degraded1
- Difficult to Advance1
- Material Separation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2026Difficult to Advance; Material Twisted/Bent
THE ACCOUNT ALLEGES THE GUIDEWIRE WAS FOUND KINKED AND WAS UNABLE TO BE INSERTED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980280 ↗MalfunctionDec 18, 2025Degraded; Degraded
THE ACCOUNT ALLEGES THAT DURING USE THE COATING OF THE GUIDEWIRE CAME OFF. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23844957 ↗MalfunctionDec 10, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING THE CORONARY ANGIOGRAPHY PROCEDURE, WHILE ADVANCING THE GUIDEWIRE AT THE BRACHIAL ARTERY, IT BENT AT THE JUNCTION WITH THE FLOPPY END, PREVENTING IT FROM ADVANCING FURTHER INTO THE VASCULAR BED. THE WIRE WAS REMOVED AND IT WAS NOTED THAT THE METAL CORE OF THE GUIDEWIRE WAS EXPOSED AND RIGID. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769984 ↗MalfunctionMar 9, 2020Fracture; Fracture
THE ACCOUNT ALLEGED THAT DURING AN ENDOVASCULAR PROCEDURE, THE GUIDEWIRE FRACTURED WITHIN THE PATIENT'S VASCULATURE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9808890 ↗MalfunctionMar 9, 2020Fracture; Fracture
THE ACCOUNT ALLEGED THAT DURING AN ENDOVASCULAR PROCEDURE, THE GUIDEWIRE FRACTURED WITHIN THE PATIENT'S VASCULATURE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9805500 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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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