Merit Medical® 00884450403983Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450403983), received between Jul 27, 2022 and Jul 27, 2022 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 CONTINUED IMPAIRMENT AND SLIGHT EXPRESSIVE APHASIA.

  Patient problems: Memory Loss/Impairment; Speech Disorder

  MAUDE report 15115093 ↗
• 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 15115051 ↗
• 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 15115009 ↗