InQwire® 00884450056295Recalls & 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450056295), received between Jan 28, 2026 and Jan 28, 2026 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Tamponade1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 28, 2026Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT A FARAVIEW PROCEDURE WAS PERFORMED WITHOUT IMAGING GUIDANCE. DURING THE PROCEDURE, NO DEVICE MALFUNCTION OR SPECIFIC INTRA-PROCEDURAL ISSUES WERE REPORTED; HOWEVER, DIFFICULTY ACCESSING THE LEFT VEINS WAS NOTED, REQUIRING MULTIPLE GUIDEWIRE INSERTION ATTEMPTS. NO ABNORMALITIES WERE IDENTIFIED ON ECHOCARDIOGRAPHY AT THE CONCLUSION OF THE PROCEDURE. SEVERAL HOURS POST-PROCEDURE, THE PATIENT DEVELOPED CLINICAL DETERIORATION, AND ECHOCARDIOGRAPHY IDENTIFIED CARDIAC TAMPONADE WITH PERICARDIAL EFFUSION. A THORACIC DRAIN WAS PLACED, RESULTING IN TEMPORARY CLINICAL IMPROVEMENT. LATER THAT NIGHT, THE PATIENT EXPERIENCED RECURRENT TAMPONADE REQUIRING EMERGENT OPEN-CHEST SURGICAL INTERVENTION. INTRAOPERATIVE FINDINGS IDENTIFIED DAMAGED TISSUE BENEATH THE LEFT PULMONARY VEINS, SUSPECTED TO BE THE SOURCE OF PERICARDIAL EFFUSION AND TAMPONADE. NO DISCRETE PERFORATION OR DEFECT OF A SPECIFIC DEVICE WAS IDENTIFIED. THE TAMPONADE WAS ASSESSED AS PROCEDURE-RELATED; HOWEVER, A DIRECT CAUSAL ASSOCIATION TO A SPECIFIC MEDICAL DEVICE COULD NOT BE ESTABLISHED. THE PATIENT REQUIRED HOSPITALIZATION BEYOND STANDARD POST-PROCEDURE CARE AND ULTIMATELY DIED.
Patient problems: Cardiac Tamponade; Pericardial Effusion
MAUDE report 24199370 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
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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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