InQwire® 00884450023563Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450023563), received between Jul 27, 2022 and May 21, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE ACCOUNT ALLEGES THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE WITH THE PATIENT UNDER SEDATION WITH PROPOFOL, A TAMPONADE OCCURRED REQUIRING THORACIC SURGERY. 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750ML OF BLOOD WAS WITHDRAWN AND IT WAS DECIDED TO DO EMERGENCY THORACIC SURGERY.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 GUIDE WIRE PROTRUDED OUT OF THE BALLOON CATHETER CAUSING A TEAR. THIS WAS NOT NOTICED AT FIRST AND THE GUIDE WIRE 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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 22061204 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT WAS EVALUATED AND TREATED FOR CAD. POST PCI PROCEDURE, THE PATIENT COMPLAINED OF LEFT ARM WEAKNESS AND WAS POSITIVELY DIAGNOSED WITH AN EMBOLIC STROKE IN RECOVERY UNIT. THE PATIENT WAS SUCCESSFULLY TREATED AND DISCHARGED TO HOME WITH LOSS OF PERIPHERAL VISION AND WEAKNESS IN THE ARM.

  Patient problems: Muscle Weakness/Atrophy; Visual Impairment

  MAUDE report 15115088 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A PATIENT WAS ADMITTED FOR CAD. POST LHC PROCEDURE THE PATIENT WAS EVALUATED IN RECOVERY UNIT. THE PATIENT EXPERIENCED EXPRESSIVE APHASIA AND WAS POSITIVELY DIAGNOSED WITH AN EMBOLIC STROKE. THE PATIENT WAS TREATED AND DISCHARGED TO HOME WITH SLIGHT APHASIA.

  Patient problems: Memory Loss/Impairment; Speech Disorder

  MAUDE report 15115081 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A PATIENT WAS EVALUATED AND TREATED FOR CAD AND AORTIC VALVE STENOSIS. POST RHC AND LHC PROCEDURE, DURING RECOVERY IN THE UNIT, THE PATIENT ALLEGED TO HAVE SLIGHT MEMORY LOSS AND ARM WEAKNESS AND WAS POSITIVELY DIAGNOSED WITH AN EMBOLIC STROKE. THE PATIENT WAS SUCCESSFULLY TREATED AND DISCHARGED TO HOME WITH SLIGHT MEMORY LOSS AND LEFT ARM WEAKNESS.

  Patient problems: Memory Loss/Impairment; Muscle Weakness/Atrophy

  MAUDE report 15114971 ↗