Prelude IDealRecalls & reported problems across all models
Merit Medical Systems, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 1
- Injuries reported
- 15
- Recalls
- 0
We found 18 models of Prelude IDeal by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2019 and Apr 29, 2026 — classified as 1 death, 15 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Fracture” (19 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 Prelude IDeal problems
Device problems
- Fracture19
- Material Separation16
- Difficult to Remove5
- Break4
- Defective Device4
- Material Twisted/Bent4
- Material Integrity Problem3
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Known Impact Or Consequence To Patient11
- Insufficient Information5
- Foreign Body In Patient2
- Inflammation2
- Pain2
- Cramp(s) /Muscle Spasm(s)1
- Foreign Body Embolism1
Prelude IDeal models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prelude IDeal™ 10884450381868INTRODUCER, CATHETER17 reports
- Prelude IDeal™ 10884450317379INTRODUCER, CATHETER4 reports
- Prelude IDeal™ 10884450317485INTRODUCER, CATHETER4 reports
- Prelude IDeal™ 10884450317621INTRODUCER, CATHETER3 reports
- Prelude IDeal™ 10884450317515INTRODUCER, CATHETER2 reports
- Prelude IDeal™ 10884450523077INTRODUCER, CATHETER2 reports
- Prelude IDeal™ 10884450684242Introducer, catheter2 reports
- Prelude IDeal™ HIntroducer, catheter1 report
- Prelude IDeal™ HIntroducer, catheter1 report
- Prelude IDeal™ 10884450317133INTRODUCER, CATHETER1 death1 report
- Prelude IDeal™ 10884450317546INTRODUCER, CATHETER1 report
- Prelude IDeal™ 10884450381837INTRODUCER, CATHETER1 report
- Prelude IDeal™ 10884450381899INTRODUCER, CATHETER1 report
- Prelude IDeal™ 10884450381929INTRODUCER, CATHETER1 report
- Prelude IDeal™ 10884450518202INTRODUCER, CATHETER1 report
- Prelude IDeal™ 10884450684600Introducer, catheter1 report
- Prelude IDeal™ 10884450693312Introducer, catheter1 report
- Prelude IDeal™ GIntroducer, catheter1 report
Recent Prelude IDeal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Difficult to Remove
IT WAS REPORTED THAT DURING USE, THE SHEATH BECAME STUCK AND THE PROVIDER HAD TO ADMINISTER AN ADDITIONAL RADIAL COCKTAIL TO REMOVE IT. THE SHEATH SHEARED SOME OF THE SIDE BRANCHES OFF OF THE RADIAL ARTERY. THE PATIENT WILL REQUIRE A CUT DOWN WITH VASCULAR TO FIX A PSEUDOANEURYSM THAT DEVELOPED.
Patient problems: Pseudoaneurysm
MAUDE report 25033734 ↗MalfunctionApr 29, 2026Fracture; Material Separation
IT WAS REPORTED THAT PART OF THE SHEATH TIP WAS FOUND TO BE BROKEN AFTER COMPLETION OF THE PROCEDURE WHEN REMOVING THE SHEATH. THE SHEATH WAS USED FOR PEDAL ACCESS. SEVERAL WIRES AND BALLOONS WERE INTRODUCED THROUGH THE SHEATH. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25033733 ↗InjuryJul 8, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem
THE ACCOUNT ALLEGES THAT IN A PATIENT WITH RIGHT RADIAL ARTERY SPASM AT THE END OF A PROCEDURE, THE DESILET INTRODUCER SYSTEM EXPERIENCED A SEPARATION BETWEEN ITS INTRAVASCULAR COMPONENT (VIOLET PART) AND THE EXTERNAL PORTION CONTAINING THE NON-RETURN VALVE (GREY PART). A FEW MILLIMETERS OF THE VIOLET SEGMENT REMAINED PROTRUDING BENEATH THE COMPRESSION BRACELET AND HAD TO BE MANUALLY GRASPED AND FORCEFULLY WITHDRAWN BY THE CARDIOLOGIST TO COMPLETE REMOVAL OF THE STENT. THE PATIENT EXPERIENCED SIGNIFICANT PAIN DURING THE EXTRACTION, WHICH WAS DIFFICULT DUE TO RESISTANCE FROM THE ARTERIAL SPASM.
Patient problems: Cramp(s) /Muscle Spasm(s); Pain
MAUDE report 22445392 ↗InjuryJun 18, 2025Difficult to Remove; Difficult to Remove
THE ACCOUNT ALLEGES THAT AFTER THE PROCEDURE, THE SHEATH WASN'T ABLE TO BE REMOVED FROM PATIENT VESSEL. THERE WERE NO ISSUES DIRECTLY RELATED TO THE PROCEDURE ITSELF. HOWEVER, INCIDENT CONCLUDED TO SURGICAL REMOVAL. DURING THE REMOVAL, THE PHYSICIAN FOUND SHEATH ESCAPING THE INTIMA, MEDIA LINE OUTSIDE THE VESSEL.
Patient problems: Foreign Body In Patient
MAUDE report 22286382 ↗MalfunctionDec 12, 2024Fracture; Fracture
DURING THE PROCEDURE, THE DOCTOR REALIZED THAT THE GUIDE WAS RUBBING A LITTLE ON THE PATIENTS WRIST. THE DOCTOR THEREFORE REMOVED IT TO TRY TO REINTRODUCE IT CORRECTLY, THE GUIDEWIRE STARTED TO UNRAVEL. DECISION TO REMOVE THE GUIDE AND NEEDLE FROM THE WRIST OF THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THIS PROCEDURE. PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20918261 ↗InjuryApr 25, 2024Material Deformation; Material Deformation
THE ACCOUNT ALLEGES THAT DURING AN ECMO PROCEDURE, THE MEDICAL STAFF NOTICED AN ACUTE CHANGE IN DISTAL PERFUSION WITHIN THE PATIENT'S LEG. BOTH NEAR-INFRARED SPECTROSCOPY [NIRS] AND CAPILLARY REFILL TESTING INDICATED A DECREASE IN THE DISTAL PERFUSION LINE EVEN THOUGH THE PERFUSION LINE APPEARED PATENT. THE ATTENDING PHYSICIAN EVALUATED THE PATIENT'S LEG AND EVEN THOUGH THE PATIENT WAS IMPROVING, THE PHYSICIAN FELT THAT THE BEST COURSE OF ACTION WAS TO REMOVE THE ECMO SUPPORT. THE PATIENT WAS REMOVED FROM ECMO SUPPORT AND UPON INSPECTION OF THE DISTAL PERFUSION CANNULA, IT APPEARED TO BE PATENT AND STILL INTACT HOWEVER, THERE WAS A LARGE KINK IN THE MIDDLE OF THE CANNULA THAT MAY HAVE IMPEDED SOME BLOOD FLOW DURING THE ECMO PROCEDURE. THE PATIENT REQUIRED A LEG AMPUTAITON. NO ADDITIONAL INFORMATION TO REPORT.
Patient problems: Ischemia
MAUDE report 19181174 ↗MalfunctionSep 4, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A CATHETERIZATION PROCEDURE, THE ACCESS WIRE DETACHED AND SHEARED OFF WHILE REMOVING THE INNER DILATOR AFTER SHEATH PLACEMENT. NO PATIENT INJURY TO REPORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17680514 ↗InjuryMar 7, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THE GUIDEWIRE FRAYED AND BECAME CAUGHT WITHIN THE PATIENT'S ANATOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16496588 ↗InjuryNov 8, 2022Fracture; Material Separation; Fracture; Material Separation
THE CUSTOMER ALLEGES THAT DURING A LEFT HEART CATH [LHC] PROCEDURE, THE TIP OF THE ACCESS WIRE DETACHED WITHIN THE PATIENTS ARTERY. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. THE PATIENT WAS DISCHARGED HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15756749 ↗InjuryNov 7, 2022Break
70Y/O MALE SCHEDULED FOR LHC (LEFT HEART CATHETERIZATION) DUE TO ABNORMAL FINDINGS DIAGNOSTIC IMAGING AND CORONARY CIRCULATION. HX (HISTORY OF CORONARY ARTERY DISEASE) OF CAD, HF (HEART FAILURE), HTN (HYPERTENSION), HYPERLIPIDEMIA, SSS (SICK SINUS SYNDROME), S/P PACEMAKER IMPLANT. ON (B)(6) 2022 S/P LHC: FINDINGS NON OBSTRUCTIVE CORONARY ARTERY DISEASE, NORMAL EF (EJECTION FRACTION) 55% AND LVEDP (LEFT VENTRICULAR END DIASTOLIC PRESSURE). TX: MEDICAL MANAGEMENT LHC REPORT: DR. : "THE TIP OF THE ACCESS WIRE BROKE AND I DECIDED TO PERFORM FEMORAL APPROACH. WE WILL PERFORM ULTRASOUND OF THE RIGHT FOREARM TO EVALUATE FOR PATENCY OF ULNAR AND RADIAL ARTERIES." PATIENT IN CATH LAB HOLDING ROOM, S/P ULTRASOUND OF RIGHT UPPER EXTREMITY ARTERIAL DOPPLER: RESULTS: PATENT RADIAL AND ULNAR ARTERIES AS CLINICALLY QUESTIONED. DR. AWARE, AND WILL DISCHARGE PATIENT. DR. SPOKE TO PATIENT AND FAMILY ON THE PHONE, RELAYED US (ULTRASONOGRAM)RESULTS AND WILL FOLLOW UP PATIENT IN 1 WEEK. GAVE INSTRUCTIONS TO PATIENT IF SEVERE PAIN AND LOSS OF SENSATION AND COLOR CHANGED ON THE HANDS TO IMMEDIATELY GO TO NEAREST EMERGENCY ROOM. MEDICAL DIRECTOR OF CATH LAB WAS NOTIFIED RECOMMEND US (ULTRASONOGRAM) AND IF
Patient problems: Pain; Skin Discoloration
MAUDE report 15754803 ↗MalfunctionJul 1, 2022Failure to Advance; Material Twisted/Bent
EARLY 50¿S MALE WITH HISTORY OF CHEST PAIN AND SUSPECTED CORONARY HEART DISEASE. PROCEDURE: LEFT AND RIGHT CORONARY HEART CATHETERIZATION. FIRST SHEATH DILATATOR KINKED WHEN USED, 2ND SHEATH WOULD NOT GO OVER THE FIRST ONE. ALL REMOVED WITHOUT KNOWN HARM TO PATIENT. NEW ACCESS WITH THIRD SHEATH THAT WAS SUCCESSFUL. MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE IDEAL (PER SITE REPORTER) WILL OBTAIN. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE IDEAL (PER SITE REPORTER) WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14884899 ↗MalfunctionApr 14, 2022Defective Device
ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE (CAD), DEEP VEIN THROMBOSIS (DVT) AND RECENT CHEST PAIN. PROCEDURE: L&R CORONARY ANGIOPLASTY, L HEART CATH, PERCUTANEOUS CORONARY INTERVENTION (PCI) IN MID- LEFT ANTERIOR DESCENDING ARTERY (LAD) AND STENT PLACEMENT. PHYSICIAN AND RN WERE UNABLE TO LOAD SHEATH ONTO ACCESS WIRE. NO KNOWN HARM TO PATIENT, MINOR DELAY. NEW SHEATH USED WITHOUT PROBLEMS. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE IDEAL¿ (PER SITE REPORTER). WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14111154 ↗InjuryFeb 2, 2022Unraveled Material; Unraveled Material
THE ACCOUNT ALLEGES THAT DURING ACCESS FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAM [PTCA] PROCEDURE, THE 6F ACCESS WIRE UNRAVELED WITHIN THE PATIENT VASCULAR SYSTEM. THE WIRE WAS NO LONGER ABLE TO BE USED FOR VASCULAR ACCESS AND HAD TO BE REMOVED. A VASCULAR SURGEON WAS CONSULTED TO ASSIST IN THE REMOVAL OF THE ACCESS WIRE WITH NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13426005 ↗InjuryJan 6, 2022Difficult to Remove; Difficult to Remove
THE ACCOUNT ALLEGES THAT FOLLOWING A SUCCESSFUL PCI PROCEDURE, THE SHEATH WAS ATTEMPTED TO BE REMOVED. THE CLINICIAN EXPERIENCED DIFFICULTY REMOVING THE DEVICE AND PROCEEDED TO CREATE AN INCISION IN THE SKIN AND VESSEL FOR SUCCESSFUL REMOVAL. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13177585 ↗InjurySep 22, 2021Difficult to Remove; Difficult to Remove
THE ACCOUNT ALLEGES THAT AT THE CONCLUSION OF THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH FROM THE PATIENT'S ARTERY BUT HAD DIFFICULTY AND FAILED. THE PATIENT HAD AN ADDITIONAL PROCEDURE THE FOLLOWING MORNING TO REMOVE THE SHEATH, WHICH WAS DONE SUCCESSFULLY. IT WAS NOTED DURING REMOVAL THAT THE SHEATH WAS EMBEDDED IN THE ARTERY. THERE IS NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Foreign Body Embolism
MAUDE report 12513221 ↗
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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