Merit Medical® 00884450581322Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450581322), received between May 1, 2024 and May 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 11, 2024Class IIOpen, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2579-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT POST RADIO FREQUENCY [RF] ABLATION PROCEDURE, THE PHYSICIAN NOTICED THE ACCESS DILATOR HAD DETACHED WITHIN THE PATIENT'S GREAT SAPHENOUS VEIN. THE PHYSICIAN NOTICED THE ACCESS SHEATH DILATOR HAD DETACHED AT THE HUB AND WAS INADVERTENTLY PUSHED FURTHER INTO THE PATIENT'S GSV BY THE PHYSICIAN DURING THE ABLATION PROCESSES. THE RF ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED WHEN THE PHYSICIAN FIRST NOTICED THE MISSING DILATOR, SO THE FOREIGN BODY DID NOT PREVENT THE SUCCESSFUL RF ABLATION TREATMENT FOR THIS PATIENT. A FOLLOW-UP ULTRASOUND STUDY VERIFIED THAT THE FOREIGN BODY WAS STILL WITHIN THE PATIENT'S VENOUS SYSTEM AND THAT THE MORE PROXIMAL PART OF THE VEIN HAD BEEN DECIMATED BY THE RF ABLATION PROCEDURE SO THERE WAS NO RISK OF FURTHER MIGRATION. THE PATIENT IS CURRENTLY ASYMPTOMATIC AND THE PHYSICIAN IS NOT INTERESTED IN SURGICAL RETRIEVAL OF THE FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19221371 ↗