Merit MAKRecalls & reported problems across all models
Merit Medical Systems, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 12 models of Merit MAK by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2019 and Dec 4, 2025 — classified as 12 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Merit MAK problems
Device problems
- Fracture17
- Material Separation17
- Material Integrity Problem2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Material Frayed1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Foreign Body In Patient9
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Merit MAK models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Merit MAK™ 00884450008812DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION5 reports
- Merit MAK™ 00884450012598DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION3 reports
- Merit MAK™ 00884450012840DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION3 reports
- Merit MAK™ 00884450011454DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Merit MAK™ 00884450012574DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Merit MAK™ 00884450022030DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Merit MAK™ 00884450028520DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Merit MAK™DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Merit MAK™ 00884450008751DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Merit MAK™ 00884450012604DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Merit MAK™ 00884450012680DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Merit MAK™ 00884450094761DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
Recent Merit MAK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A FEMORAL ANGIOGRAM PROCEDURE THE DEVICE SEPARATED FROM THE HUB. WHEN THE PROVIDER TWISTED THE SYRINGE ONTO THE HUB OF THE MICROPUNCTURE SHEATH, IT DETACHED FROM THE SHEATH AND LEFT THE SHAFT INSIDE THE VESSEL. THE PATIENT HAD TO BE TAKEN TO VASCULAR SURGERY FOR SHEATH REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 23720198 ↗MalfunctionNov 25, 2025Material Frayed; Material Frayed
CUSTOMER REPORTS DURING A CARDIAC CATH-LAB PROCEDURE, A MICRO PUNCTURE WIRE WAS INSERTED INTO THE PATIENT. UPON REMOVAL, THE WIRE BEGAN TO "FRAY"- THE PATIENT WAS EXAMINED UNDER X-RAY TO MAKE SURE NO PIECES OF THE WIRE REMAINED IN THE PATIENT'S BODY. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645276 ↗MalfunctionSep 16, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THEY ARE EXPERIENCING ISSUES WITH THE GUIDEWIRES UNRAVELLING WHILE INSIDE OF THE PATIENT. THE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23068106 ↗MalfunctionSep 16, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THEY ARE EXPERIENCING ISSUES WITH THE GUIDEWIRES UNRAVELLING WHILE INSIDE OF THE PATIENT. THE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23068104 ↗InjuryJan 8, 2025Fracture; Fracture
THE ACCOUNT ALLEGES THAT THE TIP OF THE WIRE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO SNARE IT OUT.
Patient problems: Foreign Body In Patient
MAUDE report 21102930 ↗InjuryDec 11, 2024Break; Break
CUSTOMER ALLEGES THAT THE WIRE TIP SHEARED OFF DURING VASCULAR ACCESS.
Patient problems: Foreign Body In Patient
MAUDE report 20904005 ↗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 31, 2024Material Separation; Material Separation
DURING THE PROCEDURE, THE GUIDE WIRE WAS CUT AND UNRAVELED. NO PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578355 ↗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 ↗MalfunctionJun 25, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF AN ACCESS WIRE DISLODGED WITHIN A PATIENTS VESSEL DURING ACCESS FOR HD CATHETER PLACEMENT. THE ACCESS WIRE DETACHED AND IS CURRENTLY WEDGED WITHIN THE PATIENT'S ADIPOSE TISSUE. THE PHYSICIAN IS NOT CONCERNED ABOUT POSSIBLE IATROGENIC FOREIGN BODY [IFB] MIGRATION OR EMBOLISM. THERE ARE NO PLANS TO REMOVE THE EMBEDDED IFB FROM THIS PATIENT. THE TIP OF THE ACCESS WIRE IS STERILE ENCAPSULATE.
Patient problems: Foreign Body In Patient
MAUDE report 19609853 ↗MalfunctionApr 9, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE ACCESS CATHETER DETACHED AT THE HUB. THE CLINICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DETACHED PIECE WITHOUT FUTHER INTERVENTION. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19076790 ↗InjuryOct 31, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE FOR UPPER ARM CENTRAL VENOUS ACCESS, THE TIP OF THE GUIDEWIRE DETACHED WITHIN THE VESSEL. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED OUT FROM THE PATIENT. NO OTHER PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18044407 ↗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 ↗InjuryAug 22, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT POST-PROCEDURE AN X-RAY AND CT SCAN HAD IDENTIFIED A PORTION OF THE ACCESS WIRE THAT HAD DETACHED WITHIN THE PATIENT'S CAROTID ARTERY DURING THE PROCEDURE. THE CLINICAL STAFF WAS NOT AWARE OF THIS EVENT DURING THE ACTUAL MEDICAL PROCEDURE, SO THE FOREIGN BODY WAS NOT EXTERNALIZED FROM THE PATIENT. THE PATIENT WAS EDUCATED ABOUT THIS EVENT POST PROCEDURE AND WAS ADMITTED TO THE HOSPITAL FOR CONTINUOUS MONITORING.
Patient problems: Foreign Body In Patient
MAUDE report 17599188 ↗InjuryMay 30, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THE TIP BROKE OFF APPROXIMATELY 1-2MM AND WENT IN TO THE PATIENT. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17027405 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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