InQwire® 00884450005156Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450005156), received between May 14, 2020 and Sep 17, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Customer reports during a procedure to treat atrial fibrillation an InQwire Guidewire was used. A pericardial effusion was noted after the Volt PFA Catheter was introduced into the left atrium. One ablation (in LSPV) was attempted and canceled due to a continued drop in left atrial pressure, at which time a pericardial effusion was identified via ViewFlex ICE catheter. A pericardiocentesis was performed, and the case was subsequently aborted. At the time of the event, the Volt catheter, non-Abbott device (Merit InQwire guidewire), and 13 Fr Agilis sheath were present in the patient. The exact source of the perforation remains unknown, though the Merit InQwire nor the transseptal puncture which was performed using non-Abbott device (Versacross by Boston Scientific) could not be excluded as a potential contributing factors. The patient is hemodynamically stable and currently recovering appropriately. There were no performance issues with any device.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 50800776 ↗
• MalfunctionMar 9, 2026Material Twisted/Bent

  A CUSTOMER ALLEGED DURING A PROCEDURE, THE PHYSICIAN FOUND THE TIP OF THE GUIDE WIRE WAS KINKED. IT WAS REPLACED WITH A NEW ONE TO COMPLETE PROCEDURE. NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550717 ↗
• MalfunctionNov 25, 2025Unraveled Material; Unraveled Material

  THE ACCOUNT ALLEGES THAT THE SLEEVE OF THE GUIDEWIRE WAS STRIPPED OFF WITHIN THE RUBICON CATHETER. THIS OCCURRED DURING THE REMOVAL OF THE RUBICON FROM THE PATIENT'S BODY. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649408 ↗
• MalfunctionJul 22, 2025Material Twisted/Bent; Material Twisted/Bent

  THE ACCOUNT ALLEGES THAT UNDER FLUOROSCOPY DURING THE PROCEDURE, THEY OBSERVED THAT THE GUIDEWIRE WAS BENT AND PROTRUDING SLIGHTLY. AFTER WITHDRAWING THE GUIDEWIRE, THEY FOUND A STEEL WIRE STICKING OUT AT THE BENT SECTION AND THE WIRE WAS VERY STIFF. NO INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569704 ↗
• MalfunctionSep 17, 2024

  >70 YEAR-OLD MALE WITH PAST HISTORY OF MITRAL VALVE REPLACEMENT AND RECENT CHEST PAIN WITH PLEURAL EFFUSION. PROCEDURE: CARDIAC CATHETERIZATION. WHEN THE MERIT MEDICAL, INQWIRE WAS OPENED, THERE WAS A DARK HAIR FOUND IN THE PLASTIC COUPLER OF THE J WIRE. NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, INQWIRE (PER SITE REPORTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237392 ↗
• MalfunctionMay 14, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING INCOMING INSPECTION OF THE GUIDEWIRE PACKAGING, AN OPEN SEAL WAS IDENTIFIED COMPROMISING THE STERILITY OF THE WIRE. A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONTACT OR INJURY TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10059718 ↗