InQwire® 00884450029909Recalls & 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
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450029909), received between Jul 6, 2022 and Jul 6, 2022 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT UPON SURVEY DATA REVIEW FOR THE INQWIRE PRODUCT FAMILY, AN ADVERSE EVENT INVOLVING A DIAGNOSTIC INQWIRE WAS NOTED. THE EVENT ALLEGES THAT THE GUIDE WIRE MAY HAVE CAUSED A EMBOLISM DURING STENT PLACEMENT WITHIN A PATIENT'S PERIPHERAL VASCULAR SYSTEM. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL DETAILS ARE AVAILABLE, AND THE DEVICE WILL NOT BE RETURNING FOR INVESTIGATION.
Patient problems: Insufficient Information
MAUDE report 14939966 ↗InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT UPON SURVEY DATA REVIEW FOR THE INQWIRE PRODUCT FAMILY, AN ADVERSE EVENT INVOLVING A DIAGNOSTIC INQWIRE WAS NOTED. THE EVENT ALLEGES THAT THE GUIDE WIRE MAY HAVE CAUSED A PSEUDOANEURYSM WITHIN A PATIENT'S PERIPHERAL VASCULAR SYSTEM. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL DETAILS ARE AVAILABLE, AND THE DEVICE WILL NOT BE RETURNING FOR INVESTIGATION.
Patient problems: Insufficient Information
MAUDE report 14939946 ↗
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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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