Merit S-MAK™ 00884450012628Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450012628), received between Apr 28, 2021 and Mar 26, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2024Material Fragmentation; Material Fragmentation

  THE ACCOUNT ALLEGES THAT A 77-YEAR-OLD MALE HAD A DX-CAG PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE OPERATOR HAD DIFFICULTY CANNULATING THE RIGHT RADIAL ARTERY AND AFTER SEVERAL FAILED ATTEMPTS THE RIGHT RADIAL APPROACH WAS ABANDONED, THE LEFT RADIAL ACCESS ATTEMPT WAS SUCCESSFULLY ACQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT ISSUES TO REPORT. THE PATIENT WAS DISCHARGED TO HOME. TWELVE MONTHS LATER, THE PATIENT PRESENTED ON MULTIPLE OCCASIONS WITH ONGOING PAIN AND A NON-HEALING WOUND AT THE SITE OF HIS RIGHT RADIAL ACCESS SITE. THE PATIENT HAD AN ULTRASOUND SCAN ON (B)(6) 2022 AND RECEIVED 3 COURSES OF ANTIBIOTICS. ON (B)(6) 2023 THE PRESENTED AGAIN WITH PAIN AND REDNESS OF THE RIGHT ARM. HE WAS SENT HOME THE SAME DAY WITH A DIAGNOSIS OF CELLULITIS AND A 7-DAY COURSE OF ANTIBIOTICS. THE PATIENT RETURNED TO THE ED ON (B)(6) 2023 BECAUSE HE WAS NOT RESPONDING TO THE ANTIBIOTICS. THE PATIENT WAS SYSTEMICALLY UNWELL AND WAS ADMITTED TO THE HOSPITAL FOR INTRAVENOUS ANTIBIOTICS AND FURTHER IMAGING. ON (B)(6) 2023, THE PHYSICIAN WAS CALLED TO REVIEW HIS ARM AFTER SHOWING THE RN A PIECE OF METAL PROTRUDING FROM HIS RIGHT FOREARM. THIS EVENT WAS ESCALATED TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984222 ↗
• MalfunctionFeb 2, 2022Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A LEFT ARM AV FISTULA DE-CLOT PROCEDURE, WHEN ATTEMPTING TO REMOVE THE ACCESS GUIDEWIRE THE WIRE BECAME STUCK WITHIN THE PATIENT'S FISTULA. THE PHYSICIAN WAS ABLE TO REMOVE THE MICRO ACCESS WIRE BUT, THE TIP DETACHED DURING REMOVAL AND REMAINED WITHIN THE PATIENTS CLOTTED GRAFT. A TEMPORARY DIALYSIS CATHETER IS IN PLACE UNTIL THE NEW FISTULA GRAFT CAN BE ACCESSED. NO PATIENT INJURY TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13426010 ↗
• InjuryApr 28, 2021Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT [TIPS] PROCEDURE TO CONNECT THE PORTAL VEIN TO THE HEPATIC VEIN WITHIN THE PATIENT'S LIVER, THE TIP OF THE MICRO ACCESS WIRE WITHIN THE ACCESS KIT DETACHED WITHIN THE PATIENT'S HEPATIC PARENCHYMA. THE FOREIGN WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S VENOUS SYSTEM WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739352 ↗