Merit MAK™ 00884450008812Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450008812), received between Dec 20, 2019 and Nov 26, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ADDITIONAL ATTEMPTED ACCESS WITH A 4F MAK KIT, THE ACCESS WIRE STARTED TO UNRAVEL WITHIN THE PATIENT. THE ACCESS WIRE WAS SUCCESSFULLY REMOVED WITHOUT MEDICAL INTERVENTION. ANOTHER WIRE WAS USED TO COMPLETE THIS PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784758 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING ATTEMPTED ACCESS WITH A 4F MAK KIT, THE ACCESS WIRE STARTED TO UNRAVEL WITHIN THE PATIENT. THE ACCESS WIRE WAS SUCCESSFULLY REMOVED WITHOUT MEDICAL INTERVENTION. ANOTHER WIRE WAS USED TO COMPLETE THIS PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511170 ↗
• InjurySep 4, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT THE CATHETER WAS INSERTED AND THE ACCESS GUIDEWIRE STARTED TO UNRAVEL DURING A PROCEDURE ON A PEDIATRIC PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680509 ↗
• MalfunctionAug 12, 2020Fracture; Material Separation; Fracture; Material Separation

  ACCOUNT ALLEGES THAT PART OF THE SHEATH TUBING WAS BROKE OFF IN THE PATIENT'S BODY DURING AVF PROCEDURE. BROKEN PART WAS RETRIEVED SUCCESSFULLY. NO PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10398855 ↗
• MalfunctionDec 20, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING TO ACQUIRE VENOUS ACCESS VIA SELDINGER TECHNIQUE VIA ULTRASOUND GUIDANCE. RESISTANCE WAS FELT AS THE ACCESS WIRE WAS WITHDRAWN FROM THE ACCESS NEEDLE. WHEN THE WIRE WAS REMOVED FROM THE PATIENT, IT WAS NOTED BY THE CLINICIAN THAT 2CM OF THE ACCESS WIRE HAD DETACHED WITHIN SOFT TISSUE JUST POSTERIOR TO THE PATIENT'S FEMORAL VEIN. NO ATTEMPT HAS BEEN MADE TO RETRIEVE THE WIRE TIP, AS CT SCANS VERIFY THAT THE WIRE TIP IS NOT WITHIN THE PATIENT'S VEIN AND WILL NOT MIGRATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9501035 ↗