Merit S-MAKRecalls & reported problems across all models

We found 6 models of Merit S-MAK by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2020 and Sep 1, 2026 — classified as 20 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Fracture” (27 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

Most reported Merit S-MAK problems

Merit S-MAK models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Merit S-MAK™ 00884450012635

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  22 reports
• Merit S-MAK™ 00884450012642

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  8 reports
• Merit S-MAK™ 00884450012628

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  3 reports
• Merit S-MAK™ 00884450155066

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  2 reports
• Merit S-MAK™

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  2 reports
• Merit S-MAK™ 00884450012666

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report

Recent Merit S-MAK adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Unraveled Material; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548239 ↗
• MalfunctionSep 1, 2026Unraveled Material; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548185 ↗
• InjuryAug 5, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES WHILE GAINING ACCESS FOR A CORONARY ARTERIOGRAM PROCEDURE, THE TIP OF THE MICRO PUNCTURE WIRE SHEARED OFF WHILE IN THE VESSEL. THE NEEDLE WAS INSERTED INTO THE VESSEL AND ADVANCED. SOME MINIMAL RESISTANCE WAS MET, SO THE DEVICE WAS PULLED BACK AND ATTEMPTS TO REDIRECT WERE MADE. THE ATTEMPTED REDIRECTION WAS UNSUCCESSFUL, SO THE DEVICE WAS REMOVED. THE CLINICIAN IDENTIFIED THE SHEARED TIP WHEN REMOVING THE MICRO PUNCTURE SHEATH AND WIRE DUE TO THE NEED TO RE-STICK THE ACCESS SITE. THE PATIENT WAS NOTED TO HAVE UNIQUE ANATOMY WHICH REQUIRED INSERTION AT AN UNUSUAL ANGLE. SEVERAL ATTEMPTS WERE MADE TO SNARE/RETRIEVE RETAINED WIRE BUT WERE UNSUCCESSFUL.  VASCULAR SURGERY WAS CONSULTED AND THE DECISION WAS MADE TO BRING PATIENT TO THE FOR A CUTDOWN, EXPLORATION, AND REMOVAL OF RETAINED WIRE. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED. NO ADDTIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717377 ↗
• MalfunctionJul 29, 2025Break; Break

  THE ACCOUNT ALLEGES DURING ACCESS FOR PROCEDURE (CORONARY ARTERIOGRAM WITH POSSIBLE INTERVENTION) THE TIP OF THE MICROPUNCTURE WIRE SHEARED OFF. THEY NOTICED SHEARED TIP WHEN REMOVING THE MICROPUNCTURE SHEATH AND WIRE DUE TO THE PLACEMENT BEING TOO LOW AND NEEDING TO RE-STICK THE ACCESS SITE. SEVERAL ATTEMPTS MADE TO SNARE/RETRIEVE RETAINED WIRE BUT WERE UNSUCCESSFUL. VASCULAR SURGERY CONSULTED AND DECISION WAS MADE TO BRING PATIENT EMERGENTLY TO VASCULAR OR FOR CUTDOWN, EXPLORATION, AND REMOVAL OF RETAINED WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22647407 ↗
• 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 ↗
• MalfunctionDec 5, 2024Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTS, THE PATIENT PRESENTED FOR A TAVR PROCEDURE. AFTER PLACING AN INCISION INTO THE SKIN NEAR THE LEFT FEMORAL ACCESS SITE, WHILE REMOVING THE SHEATH THEY NOTICED ONLY A PIECE OF THE MICRO ACCESS SHEATH CAME OUT AND NOT THE ENTIRE SHEATH. VASCULAR SURGERY CAME DOWN AND AN ANGIOGRAM WAS PERFORMED. NOTHING WAS OBSTRUCTING THE BLOOD FLOW IN THE ARTERY. THE PIECE WAS NOT VISUALIZED IN THE LEFT COMMON FEMORAL ARTERY ANGIOGRAM. VASCULAR SAID BECAUSE THERE IS GOOD BLOOD FLOW, AND THE RISKS OF EXPLORING THE GROIN SURGICALLY OUTWEIGH THE BENEFITS, NO FURTHER INTERVENTION IS NEEDED. THE SHEATH IS EMBEDDED IN THE SUBCUTANEOUS TISSUES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20858465 ↗
• 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 14, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE, THE DISTAL PORTION OF THE WIRE BROKE OFF WITHIN THE ILIACA COMMUNIS. WHEN THE CLINICIAN ATTEMPTED TO PULL IT BACK INTO THE NEEDLE, THE DETACHED PIECE WAS PUSHED FURTHER INTO THE FEMORAL ARTERY. THE DETACHED PIECE REMAINS WITHIN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19981761 ↗
• InjuryAug 7, 2024Break; Break

  THE ACCOUNT ALLEGES THAT DURING A WATCHMAN CASE, WHEN OBTAINING VENOUS ACCESS THERE WAS RESISTANCE REMOVING THE NEEDLE. PATIENT WAS AVERAGE IN SIZE. THE PROVIDER ADVANCED THE NEEDLE AND THEN WAS ABLE TO REMOVE IT. THEY ADVANCED THE DILATOR AND REMOVED THE WIRE. WHEN THEY INSERTED THE SHEATH FLUOROSCOPY REVEALED THE TIP OF THE WIRE INSIDE OF THE VEIN. THEY WERE ABLE TO SNARE IT AND IT WAS SAFELY REMOVED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928266 ↗
• MalfunctionJul 17, 2024Fracture; Fracture

  THE ACCOUNT ALLEGES THE HUB SNAPPED FROM THE REST OF THE SHEATH. THE DISTAL TUBE WAS REMOVED WITH FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763555 ↗
• InjuryJul 3, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO ACQUIRE VASCULAR ACCESS DURING A PROCEDURE, THE ACCESS GUIDEWIRE TIP SNAPPED/DETACHED WITHIN THE PATIENT DURING REMOVAL. THE FOREIGN BODY WAS SUCCESSFULLY REMOVED BY THE PHYSICIAN. NO ADDITIONAL INFORMATION HAS BEEN FORWARDED TO THE MANUFACTURER AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668470 ↗
• MalfunctionJun 25, 2024Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR INTERVENTION PROCEDURE, THE MICROPUNCTURE ACCESS WIRE WAS INADVERTENTLY SHEARED OFF DURING AN ACCESS ATTEMPT WITHIN THE PATIENT'S RIGHT INTERNAL JUGULAR (RIJ) VEIN. THE FOREIGN BODY BECAME EMBEDDED WITHIN THE PATIENT'S VASCULAR WALL/TISSUE. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 19609867 ↗
• MalfunctionApr 16, 2024Unraveled Material; Unraveled Material

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE DEVICE UNCOILED WHICH LEAD TO THE DEVICE BEING DISPROPORTIONALLY LARGE ON ONE END AND THIN ON THE OTHER. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117165 ↗
• 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 ↗
• MalfunctionMar 19, 2024Unraveled Material; Unraveled Material

  THE ACCOUNT ALLEGES THAT DURING A MICROVASCULAR ACCESS ATTEMPT, THE ACCESS WIRE UNRAVELED IN THE PATIENT. NO PATIENT INJURY TO REPORT, THE DEVICE WAS REMOVED WITH NO ADDITIONAL MEDICAL INTERVENTION NEEDED, AND A NEW WIRE WAS USED FOR THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938072 ↗

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