InQwire® 00884450198827Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of InQwire (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450198827), received between Jan 17, 2023 and Apr 1, 2024 — classified as 1 death, 1 injury.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Cardiac Arrest1
- Cardiac Tamponade1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE A FARAWAVE PULSED FIELD ABLATION CATHETER WAS SELECTED FOR USE. THE ATRIAL APPENDAGE WAS PERFORATED BY THE GUIDEWIRE WHILE SEARCHING FOR THE LEFT INFERIOR PULMONARY VEIN WHICH CAUSED CARDIAC TAMPONADE. NO ADDITIONAL DETAILS AVAILABLE.
Patient problems: Cardiac Tamponade
MAUDE report 19016404 ↗DeathJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT POST CARDIAC CATHETERIZATION PROCEDURE ON (B)(6) 2021, THE PATIENT SUFFERED CARDIAC COMPLICATIONS RESULTING IN CARDIAC ARREST AND PATIENT EXPIRATION ON THE SAME DAY. A DIAGNOSTIC GUIDEWIRE AND AN INFLATION DEVICE WERE USED DURING THE PROCEDURE. NO SPECIFIC DEVICE FAILURES HAVE BEEN COMMUNICATED ONLY VAGUE ALLEGATIONS OF VARIOUS MEDICAL DEVICES BEING UNFIT FOR USE HAVE BEEN COMMUNICATED.
Patient problems: Cardiac Arrest
MAUDE report 16187854 ↗
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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 13, 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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