PreludeRecalls & reported problems across all models
Merit Medical Systems, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Prelude model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 1
We found 22 models of Prelude by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2020 and Dec 15, 2025 — classified as 19 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Fracture” (20 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Prelude recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 12, 2024Open, Classified
7F sheath introducers labeled as 7.5F
Z-3190-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported Prelude problems
Device problems
- Fracture20
- Material Separation16
- Adverse Event Without Identified Device or Use Problem5
- Detachment of Device or Device Component3
- Tear, Rip or Hole in Device Packaging3
- Crack1
- Fluid/Blood Leak1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Foreign Body In Patient8
- Pseudoaneurysm3
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Obstruction/Occlusion1
Prelude models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prelude® FDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Prelude® 10884450331368DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION3 reports
- Prelude® 10884450602901DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION3 reports
- Prelude® 10884450614959DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION3 reports
- Prelude® 10884450011390DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Prelude® 10884450015107DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Prelude® 10884450050726DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Prelude® 10884450330590DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Prelude® 10884450331870DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Prelude® 10884450614096DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- Prelude® 10884450008093DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450013769DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450050740DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450055387DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450331337DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450614027DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450614584DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450614607DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450614614DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450615079DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® 10884450615109DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- Prelude® GDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
Recent Prelude adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PUBLISHED CLINICAL STUDY DESCRIBING USE OF THE MERIT PRELUDE SHEATH INTRODUCERS ALLEGES THAT A PSEUDOANEURYSM (SUPERFICIAL FEMORAL) OCCURRED DURING USE. THE PSEUDOANEURYSM WAS ASSOCIATED WITH A MINUTE PERFORATION THAT WERE NOT RECOGNIZED DURING THE PROCEDURE AND LATER SURGICALLY REPAIRED. NO SHEATH FAILURE WAS REPORTED.
Patient problems: Pseudoaneurysm
MAUDE report 23810468 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PUBLISHED CLINICAL STUDY DESCRIBING USE OF THE MERIT PRELUDE SHEATH INTRODUCERS ALLEGES THAT PATIENTS EXPERIENCED MULTIPLE COMPLICATIONS ACUTE THROMBOSIS/DISSECTION,ARTERIAL ACCESS COMPLICATIONS, GROIN HEMATOMA, GROIN INFECTION, PSEUDOANEURYSM, STENT OCCLUSIONS, AND MAJOR AMPUTATIONS. NO EXPLICIT PRELUDE SHEATH MALFUNCTION WAS IDENTIFIED; EVENTS REPRESENT VASCULAR AND ACCESS-SITE COMPLICATIONS OCCURRING IN THE SETTING OF DEVICE USE.
Patient problems: Hematoma; Obstruction/Occlusion; Pseudoaneurysm; Thrombosis/Thrombus; Unintended Loss of Vascular Access; Unspecified Infection; Vascular Dissection
MAUDE report 23810435 ↗MalfunctionDec 15, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING NURSING CARE, THE PATIENT WAS TURNED ON THEIR SIDE AND A LARGE POOL OF BLOOD WAS OBSERVED IN THE BED. THE CATHETER WAS EXAMINED AND THE SIDE ARM HAD BROKEN OFF. NO PATIENT INJURY TO REPORT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23810432 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PUBLISHED CLINICAL STUDY DESCRIBING USE OF THE MERIT PRELUDE SHEATH INTRODUCERS ALLEGES THAT A PSEUDOANEURYSM (COMMON FEMORAL) OCCURRED DURING USE. THE PSEUDOANEURYSM WAS ASSOCIATED WITH A MINUTE PERFORATION THAT WERE NOT RECOGNIZED DURING THE PROCEDURE AND LATER SURGICALLY REPAIRED. NO SHEATH FAILURE WAS REPORTED.
Patient problems: Pseudoaneurysm
MAUDE report 23810431 ↗InjuryJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING THE OPERATION OF THE ECMO ARTIFICIAL CARDIOPULMONARY MACHINE, THE SIDEARM TUBING OF THE SHEATH DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22569714 ↗InjuryMay 20, 2025Fracture; Fracture
THE ACCOUNT ALLEGES THAT THE WIRE DETACHED INSIDE THE RADIAL ARTERY WHILST TAKING THE WIRE OUT. PATIENT WILL HAVE THE BROKEN PIECE SURGICALLY REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 22054103 ↗InjuryJan 7, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE SHEATH DETACHED WITHIN THE RADIAL ARTERY. THE DETACHED PIECE WAS RETRIEVED THROUGH SURGICAL INTERVENTION. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21098101 ↗MalfunctionSep 3, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING AN ECMO PROCESS IN THE ICU, THE NURSE FOUND BLOOD COMING FROM A PUNCTURE WHILE CLEANING THE PATIENT'S GROIN AREA. THE CLINICIAN WAS CALLED IN TO EXAMINE THE PATIENT. UPON INVESTIGATION IT WAS DISCOVERED THE SIDE OF THE SHEATH WAS CRACKED AND LEAKING BLOOD. A SPECIALIST WAS CALLED IN TO RESET THE SHEATH. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20131243 ↗MalfunctionJul 17, 2024Fracture; Fracture
THE ACCOUNT ALLEGES THAT AFTER AN ABLATION PROCEDURE, THE DOCTOR WENT TO REMOVE THE INTRODUCER AND IT BROKE, LEAVING A PART IN THE PATIENT'S INGUINAL VEIN THAT HAD TO BE REMOVED WITH TWEEZERS.
Patient problems: Foreign Body In Patient
MAUDE report 19763534 ↗MalfunctionJul 9, 2024Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING AN INTRA-ARTERIAL [IA] THROMBECTOMY PROCEDURE, THE SIDE ARM TUBING ON THE SHEATH DETACHED AFTER 5 DAYS OF ECMO INFUSION. THE DEVICE WAS REPLACED, NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19702684 ↗InjuryMay 15, 2024Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT WHEN THE PHYSICIAN USED THE 7F SHEATH FOR CONTRAST SURGERY, THE PATIENT'S BLOOD VESSELS WERE SPASMODIC. AFTER THE SPASMODIC STOPPED, THE SHEATH WAS PULLED OUT FROM BODY AND IT WAS FOUND THAT THE SHEATH WAS BROKEN AND A PART OF IT REMAINED IN THE PATIENT'S BODY. LATER, OTHER DEVICES WERE USED TO HELP PULL OUT THE REST OF THE PIECES.
Patient problems: Foreign Body In Patient
MAUDE report 19320544 ↗InjuryApr 23, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE ACCESS SHEATH DETACHED AT THE TIME OF EXTRACTION, LEAVING HALF OF THE SHEATH INSIDE THE PATIENT'S VEIN; A VASCULAR SNARE DEVICE WAS USED TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19165541 ↗MalfunctionApr 16, 2024Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING USE THE SIDE PORT OF THE SHEATH BROKE OFF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19121936 ↗InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT WHEN USING THE PRODUCT FOR PUNCTURE, IT IS NOT FLEXIBLE AND DAMAGED THE ARTERY DUE TO ITS RIGIDITY. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Perforation of Vessels
MAUDE report 18038416 ↗MalfunctionOct 24, 2023Fracture; Material Separation; Fracture; Material Separation
THE CUSTOMER REPORTS THE HUB OF THE DILATOR SNAPPED OFF AND THE BODY REMAINED IN PATIENT, BUT THE PHYSICIAN WAS ABLE TO CATCH AND REMOVE IT. NO PATIENT HARM WAS NOTED ON THIS CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18000172 ↗
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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