Merit Medical® 00884450387320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450387320), received between Feb 6, 2020 and Feb 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2020Crack; Crack

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION [PCI] PROCEDURE, THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S AORTA WITH A GUIDEWIRE AND GUIDE CATHETER TO SUCCESSFULLY CANNULATE AND OPACIFY THE CORONARY VASCULAR SYSTEM. THE ACCOUNT STATES THAT FOLLOWING A BALLOON ANGIOPLASTY, AIR WAS IDENTIFIED WITHIN THE INJECTION MANIFOLD. THE MANIFOLD SYRINGE WAS PULLED BACK AND A CRACK WAS IDENTIFIED AT THE CONTROL SYRINGE CONNECTION PORT. A NEW MANIFOLD WAS PREPPED PER INDUSTRY PROTOCOL, AND THE PROCEDURE CONTINUED. AIR WAS NOT IDENTIFIED -UNDER FLUOROSCOPIC IMAGING- ENTERING THE PATIENT DURING THIS PROCEDURE. THE PHYSICIAN THEN NOTED TWO NEW FILLING DEFECTS WITHIN THE PATIENT'S ARTERY. THE PATIENT BECAME PROGRESSIVELY HYPOTENSIVE AND A CODE BLUE WAS INITIATED. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS SUCCESSFULLY ACHIEVED AND THE PROCEDURE CONTINUED. SEVENTEEN MINUTES LATER, THE PATIENT CODED AGAIN. THE TEAM WAS NOT ABLE TO RECOVER THE PATIENT. THE PATIENT EXPIRED ON THE PROCEDURE ROOM TABLE. THE ACCOUNT ALLEGES THAT THE CAUSE OF DEATH WAS AN ANTERIOR WALL MYOCARDIAL INFARCTION, SECONDARY TO THROMBOSIS OF A HIGH-G

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9679257 ↗