Merit S-MAK™ 00884450012635Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00884450012635), received between Feb 14, 2020 and Aug 5, 2025 — classified as 11 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 1, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE BROKE A APART WITHIN THE PATIENT. THE DEVICE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH NO ADDITIONAL CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049092 ↗
• InjuryOct 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING TO ACQUIRE VASCULAR ACCES VIA THE PATIENTS JUGULAR VEIN WITH AN ACCESS NEEDLE AND 0.018 GUIDEWIRE INTO THE PATIENTS SUPERIOR VENA CAVA, THE LAST CM OF THE GUIDEWIRE DETACHED AND HOOKED ONTO THE PAPILLARY MUSCLE OF THE HEART. THE GUIDEWIRE WAS SUCCESSFULLY EXTRACTED WITH A VASCULAR SNARE DEVICE CAUSING NO ADDITIONAL PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869366 ↗
• InjuryJul 26, 2023Fracture; Fracture

  THE ACCOUNT ALLEGES THAT AFTER OBTAINING VASCULAR ACCESS, A LONG 032 GUIDEWIRE WAS PLACED INTO THE SVC (SUPERIOR VENA CAVA). THE DISTAL PART OF THE MICROPUNCTURE SHEATH BROKE WHILE REMOVING IT FROM THE VASCULATURE OVER THE GUIDEWIRE. THE SUPERFICIAL AREA ALONG THE SKIN AND SUBCUTANEOUS TISSUE AT THE ENTRY SITE WAS EXPLORED TO SEE IF THE DISTAL PART COULD BE IDENTIFIED AND REMOVED WITHOUT SUCCESS. A 16 FRENCH LONG SHEATH WAS PLACED OVER THE GUIDEWIRE. USING THE SAME SHEATH, A SNARE WAS USED TO GRASP THE DISTAL END OF THE J-WIRE. THE WIRE AND THE SNARE WERE SIMULTANEOUSLY PULLED BACK INTO THE LONG 16 FRENCH SHEATH. ONCE BOTH WERE WELL INTO THE SHEATH, ANOTHER GUIDEWIRE WAS PLACED TO RETAIN ACCESS. THE SHEATH, THE ORIGINAL 032 GUIDEWIRE AND THE SNARE WERE ALL THEN PULLED OUT OF THE VASCULATURE. THE SNARE AND THE ORIGINAL GUIDEWIRE WERE THEN FREED UP FROM THE REMOVE SHEATH AND THE BROKEN FRAGMENT OF THE MICROPUNCTURE SHEATH WAS IDENTIFIED TO ENSURE THAT THE ENTIRE FRAGMENT WAS REMOVED WITHOUT ANY RETAINED FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17399137 ↗
• MalfunctionJul 20, 2023Material Fragmentation; Detachment of Device or Device Component

  AFTER OBTAINING VASCULAR ACCESS, A LONG 032 GUIDEWIRE WAS PLACED INTO THE SVC (SUPERIOR VENA CAVA). THE DISTAL PART OF THE MICROPUNCTURE SHEATH BROKE WHILE REMOVING IT FROM THE VASCULATURE OVER THE GUIDEWIRE. WE EXPLORED THE SUPERFICIAL AREA ALONG THE SKIN AND SUBCUTANEOUS TISSUE AT THE ENTRY SITE TO SEE IF WE COULD IDENTIFY THE DISTAL PART AND REMOVE IT. WE WERE UNABLE TO VISUALIZE IT. WE DID NOT SEE IT ON FLUOROSCOPY EITHER. I THEN ELECTED TO PLACE A 16 FRENCH LONG SHEATH OVER OUR GUIDEWIRE. USING THE SAME SHEATH, I ADVANCED IN AND SNARE AND GRASPED THE DISTAL END OF THE J-WIRE TO AVOID DISTAL EMBOLIZATION OF THIS. THE WIRE AND THE SNARE WERE SIMULTANEOUSLY PULLED BACK INTO THE LONG 16 FRENCH SHEATH. ONCE BOTH WERE WELL INTO THE SHEATH, ANOTHER GUIDEWIRE WAS PLACED TO RETAIN ACCESS. THE SHEATH, THE ORIGINAL 032 GUIDEWIRE AND THE SNARE WERE ALL THEN PULLED OUT OF THE VASCULATURE. THE SNARE AND THE ORIGINAL GUIDEWIRE WERE THEN FREED UP FROM THE REMOVE SHEATH AND WE WERE ABLE TO IDENTIFY THE BROKEN FRAGMENT OF THE MICROPUNCTURE SHEATH. THIS WAS CAREFULLY ASSESSED TO ENSURE THAT THE ENTIRE FRAGMENT WAS REMOVED WITHOUT ANY RETAINED FRAGMENTS.

  Patient problems: Insufficient Information

  MAUDE report 17360525 ↗
• MalfunctionJul 3, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS VASCULAR ACCESS ATTEMPT FOR A 70YO MALE PATIENT DIAGNOSED WITH VENOUS THROMBOSIS (CVT), THE PRIMARY ACCESS WIRE WAS UNABLE TO BE RETRIEVED FROM THE PATIENT'S LEFT FEMORAL ARTERY BY THE PHYSICIAN ASSISTANT [PA]. DIRECT PRESSURE WAS HELD AT THE FEMORAL ACCESS SITE AWAITING THE ATTENDING PHYSICIAN'S ARRIVAL FOR ASSISTANCE. THE PHYSICIAN WAS INVOLVED IN ANOTHER PROCEDURE AT THE TIME. WHEN THE PHYSICIAN ARRIVED, SECONDARY ACCESS WAS SUCCESSFULLY ACQUIRED, VIA A NEW MICROPUNCTURE ACCESS WIRE. A SHEATH WAS PLACED IN THE PATIENT'S RIGHT FEMORAL ARTERY IN ORDER TO ACQUIRE MULTIPLE ANGIOGRAPHIC VIEWS [X4] OF THE PATIENT'S LEFT FEMORAL ARTERIAL SYSTEM. THE PHYSICIAN ATTEMPTED TO REMOVE THE ENTRAPPED PRIMARY ACCESS WIRE BUT ONLY PART OF THE ACCESS WIRE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE MEDICAL STAFF MADE THE DECISION TO COMPLETE THE ABLATION PROCEDURE WITH THE FOREIGN BODY STILL ENTRAPPED WITHIN THE LEFT FEMORAL ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17253099 ↗
• MalfunctionJun 21, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS NEPHROSTOMY STENT PLACEMENT PROCEDURE, THE .018 MAK-VN ACCESS GUIDE WIRE DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS NON VASCULAR AND EASILY RETRIEVED BY THE PHYSICIAN HAND. NO PATIENT INJURY TO REPORT. ANOTHER ACCESS WIRE WAS USED TO COMPLETE THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171686 ↗
• InjuryMay 10, 2023Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A LEFT SUPERIOR FEMORAL AND TIBIAL ARTERY ANGIOPLASTY PROCEDURE ON A 79YO PATIENT, 2CM OF HYDROPHILIC COATING MAY HAVE DETACHED FROM THE MICROPUNCTURE ACCESS SHEATH AND WAS RETAINED WITHIN THE PATIENT'S COMMON ILIAC ARTERY. THE PATIENT BECAME SEVERELY BRADYCARDIC DURING THIS PROCEDURE, SO THE PROCEDURE WAS CANCELED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16908518 ↗
• MalfunctionJan 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING ACCESS FOR A PERIPHERAL ANGIOGRAM PROCEDURE, THE HUB OF THE MICRO INTRODUCER SHEATH DETACHED LEAVING THE CATHETER WITHIN THE PATIENT'S ARTERY. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE BY HAND. NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098514 ↗
• InjuryDec 8, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A AV-FISTULA DECLOT PROCEDURE, THE ACCESS CATHETER DETACHED FROM THE HUB INSIDE THE PATIENT'S ARM. THE ACCOUNT ALLEGES THAT THE CATHETER MAY HAVE BEEN CAUGHT ON SOMETHING WITHIN THE FISTULA THE WAY IT STRETCHED BEFORE IT BROKE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR SURGICAL REMOVAL OF THE FOREIGN BODY. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941614 ↗
• InjuryJun 16, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT WORKUP THE CLINICIAN ATTEMPTED TO ACQUIRE RIGHT FEMORAL VEIN ACCESS TO START THE RHC. HOWEVER, AS THE CLINICIAN INSERTED THE WIRE INTO THE FEMORAL VEIN, SEVERAL PARTS OF THE WIRE, INCLUDING THE TIP, BROKE OFF WITHIN THE PATIENT. THE CLINICIAN ATTEMPTED TO REMOVE THE PIECES USING A SNARE BUT WAS UNSUCCESSFUL. A CARDIOVASCULAR SURGEON WAS CONSULTED AND THE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14721663 ↗
• InjuryFeb 15, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CARDIAC CATHETERIZATION WHILE ACCESSING THROUGH THE PATIENT'S RIGHT FEMORAL ARTERY, THE INNER CANULA OF THE DILATOR BROKE OFF INSIDE THE VESSEL. A VASCULAR PHYSICIAN WAS ASKED TO HELP WITH THE REMOVAL OF THE DETACHED PIECES. ANTIBIOTICS WERE ADMINISTERED POST PROCEDURE. THE PATIENT REMAINED SEDATED AND COMFORTABLE THROUGHOUT ENTIRE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13536841 ↗
• InjuryNov 9, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING TO ACQUIRE VASCULAR ACCESS FOR A SCHEDULED PROCEDURE, THE TIP OF THE MICROPUNCTURE ACCESS WIRE DETACHED WITHIN THE PATIENTS VASCULATURE. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE FOREIGN BODY FROM THE NATIVE VESSEL. NO ADDITIONAL ACCESS RELATED COMPLICATIONS TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781044 ↗
• MalfunctionJul 23, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE OF A MERIT MICRO-PUNCTURE CATHETER TO PERFORM ANGIOGRAPHY OF LEFT LEG FEMORAL DIALYSIS GRAFT, THE SHAFT BROKE OFF THE HUB AND ABOUT 10CM REMAINED INSIDE THE PATIENT, IN THE ARTERIAL LIMB OF THE GRAFT. THE DEVICE WAS ABLE TO BE ACCESSED AND REMOVED WITH A SNARE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317185 ↗
• MalfunctionJul 16, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN USING A MICRO-PUNCTURE KIT FOR NON-VASCULAR PROCEDURAL ACCESS, THE SHEATH TIP JUST BELOW THE RADIOPAQUE MARKER BAND DETACHED WITHIN THE PATIENT'S COMMON BILE DUCT. THE SHEATH'S INTRODUCER WAS EASILY REMOVED FROM THE SHEATH WITH NO RESISTANCE. THE PHYSICIAN PASSED AN .035 AMPLATZ EXTRA STIFF GUIDEWIRE THROUGH THE SHEATH, AND WAS ATTEMPTING TO REMOVE THE SHEATH FROM THE PATIENT WHEN THE SHEATH TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283495 ↗
• InjuryFeb 14, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGED THAT THE CATHETER FRACTURED WITHIN THE PATIENT. THE DETACHED PORTION WAS RETRIEVED WITH A VASCULAR SNARE DEVICE WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 9712689 ↗