Merit S-MAK™ 00884450012642Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884450012642), received between Jun 29, 2021 and Feb 20, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE TIP OF THE WIRE (LESS THAN 1MM) DETACHED IN THE SOFT TISSUE OF THE NECK DURING THE PROCEDURE. THE INTERVENTIONAL RADIOLOGIST AND PEDIATRIC SURGEON RECOMMENDED NO INTERVENTION, INTENTIONALLY LEAVING THE TIP OF THE WIRE WITHIN THE TISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21420480 ↗
• MalfunctionSep 3, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A FEMORAL ENTRY CATH PROCEDURE THE INNER DILATOR BROKE WITHIN THE PATIENT. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131242 ↗
• InjuryAug 22, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT THE MICRO PUNCTURE WIRE BROKE OFF WITHIN THE PATIENT. THE PHYSICIAN WAS ABLE TO SNARE THE WIRE SUCCESSFULLY TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595922 ↗
• InjuryFeb 1, 2023Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING ANTERIOR TIBIAL [AT] ARTERY ACCESS FOR A PERIPHERAL VASCULAR PROCEDURE, THE ACCESS WIRE STARTED TO UNRAVEL. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS BUT WAS NOT HAPPY WITH THE WIRE LOCATION. THE PHYSICIAN REMOVED THE ACCESS NEEDLE AND WIRE TOGETHER. THE ACCESS WIRE WAS TRAPPED WITHIN THE PATIENT. THE WIRE HAD STARTED TO UNCOIL BUT WAS SUCCESSFULLY REMOVED. THE ACCOUNT ALLEGES THAT THE ACCESS WIRE TIP HAD BEEN RETRIEVED FROM THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PATIENT PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278574 ↗
• InjuryMay 11, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE OBTAINING VEIN ACCESS FOR A LEFT-SIDED PACEMAKER IMPLANT, THE DEVICE BECAME ENTANGED AND THE TIP OF THE DEVICE DETACHED WITHIN THE PATIENT. AFTER CONSULTATION, IT WAS DECIDED BY THE CLINICAN TO LEAVE THE FOREIGN BODY WITHIN THE PATIENT AS THE RISKS WERE DEEMED TO OUTWEIGHED THE BENEFITS OF RETRIEVAL. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14366283 ↗
• MalfunctionMay 11, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING VASCULAR ACCESS FOR A PROCEDURE, THE TIP OF THE ACCESS WIRE BROKE OFF AND BECAME EMBEDDED WITHIN THE PATIENT'S TISSUE. POST PROCEDURE. THE PATIENT REQUIRED AN EMERGENT MRI FOR NON-RELATED ISSUE. THE ACCOUNT WAS NOTIFIED THAT MERIT DOES NOT HAVE MRI COMPATIBILITY DATA ON ACCESS WIRE TIPS. IT IS UNKNOWN IF THE PATIENT COMPLETED AN MRI STUDY. THE TIP HAS NOT BEEN REMOVED. NO ADDITIONAL INFORMATION ABOUT THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14365497 ↗
• InjuryNov 9, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE WIRE COMPLETELY BROKE AND A C-ARM WAS NEEDED TO RETRIEVE THE BROKEN PIECE. NO PATIENT HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12780941 ↗
• InjuryJun 29, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT IN THE OR THE TIP BROKE OFF OF THE MICRO PUNCTURE KIT. PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY FOR REMOVAL OF THE PORTION OF THE WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12088470 ↗