InQwire® 00884450196380Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450196380), received between Jul 17, 2024 and Jul 17, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Labelling, Instructions for Use or Training Problem1
- Unclear Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2024Labelling, Instructions for Use or Training Problem; Unclear Information; Labelling, Instructions for Use or Training Problem; Unclear Information
THE CUSTOMER REPORTS A LARGE EFFUSION WAS NOTICED AFTER THE ABLATION PROCEDURE WAS COMPLETED. THE PHYSICIAN STATES THAT THEY DID ATTEMPT TO ADVANCE THE GUIDEWIRE AGAINST INNER TISSUES MULTIPLE TIMES. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19760330 ↗
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- 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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