Merit MAK™ 00884450012680Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450012680), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 injury.

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.

• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING TREATED FOR STROKE. POST STROKE, PATIENT DEMONSTRATED CEREBRAL VASCULAR SPASMS, WHICH REQUIRED DIRECT INFUSION OF THE VESSELS. A CATHETER WAS INTRODUCED THROUGH THE RIGHT FEMORAL ARTERY AND FED TO THE CEREBRAL VESSELS. FOLLOWING REMOVAL OF THE CATHETER, THE VESSEL WAS SEALED USING THE ABBOTT STARCLOSE DEVICE. PATIENT HAD RECEIVED MULTIPLE TREATMENTS DURING TREATMENT AND HAD RECEIVED 4 OR 5 SIMILAR CATHETERIZATIONS THROUGHOUT THE WEEK OF HER TREATMENT. PATIENT WAS AGAIN CATHETERIZED THROUGH THE RIGHT FEMORAL ARTERY. AT THIS POINT, SEVERAL STARCLOSE DEVICES WERE ALREADY PRESENT IN THE VESSEL. A MERIT MEDICAL 4FR 10CM INTRODUCER WAS USED. DURING CATHETERIZATION, THE INTRODUCER RUBBED AGAINST THE STARCLOSE DEVICES, REMOVING A PIECE OF THE INTRODUCER TIP. THE BROKEN PIECE WAS RETAINED IN THE ARTERY. PATIENT RECEIVED ADDITIONAL SURGERY TO REMOVE THE RETAINED FOREIGN BODY. THE BROKEN PIECE WAS REMOVED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008293 ↗