InQwire® 00884450018354Recalls & 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 00884450018354), received between Jun 10, 2025 and Jun 10, 2025 — classified as 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Tamponade1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2025Adverse 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 WITH THE PATIENT UNDER SEDATION WITH PROPOFOL A TAMPONADE OCCURRED REQUIRING THORACIC SURGERY DUE TO A NON-MERIT GUIDEWIRE. AFTER SUCCESSFUL TRANSSEPTAL PUNCTURE, THE LEFT SUPERIOR AND INFERIOR PULMONARY VEIN WERE ISOLATED. AFTER DEFLATING AND RETRACTING THE BALLOON CATHETER FROM THE LEFT INFERIOR PULMONARY VEIN, THERE WAS A DROP IN BLOOD PRESSURE. A TRANSTHORACIC ECHOGRAPHY REVEALED ACCUMULATING PERICARDIAL BLOOD. WITH A PERICARDIAL PUNCTURE >750ML OF BLOOD WAS WITHDRAWN AND IT WAS DECIDED TO DO EMERGENCY THORACIC SURGERY. THIS REVEALED A 2 CM ANTERO-SUPERIOR TEAR OF THE LEFT INFERIOR PULMONARY VEIN. THE TEAR WAS SUTURED AND THE PATIENT STABILIZED. THE PATIENT WAS MOVED TO THE ICU FOR FURTHER OBSERVATION. IT IS ALLEGED THAT WHILE SWITCHING TO THE LEFT INFERIOR PULMONARY VEIN, THE GUIDEWIRE PROTRUDED OUT OF THE BALLOON CATHETER CAUSING A TEAR. THIS WAS NOT NOTICED AT FIRST AND THE GUIDEWIRE WAS ADVANCED IN THE DIRECTION OF THE LEFT INFERIOR PULMONARY VEIN. THE BALLOON WAS THEN ADVANCED AND INFLATED. AFTER DEFLATING, THE BALLOON NO LONGER BLOCKED THE TEAR AND THE TAMPONADE WAS THEN NOTED. THE PHYSICIAN ALLEGES THE
Patient problems: Cardiac Tamponade
MAUDE report 22176198 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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