Prelude RoadsterRecalls & reported problems across all models
Merit Medical Systems, Inc. · 33 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Prelude Roadster model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 33 models of Prelude Roadster by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Oct 27, 2022 and Oct 27, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
3 FDA recall records name at least one of these models by its device identifier, 3 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
Prelude Roadster 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.
- May 22, 2024Class IIOpen, Classified
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
Z-2218-2024 · Root cause: Device Design · names 33 of these models · Recall details · FDA record ↗
- Mar 14, 2024Class IIOpen, Classified
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Z-1875-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Mar 14, 2024Class IIOpen, Classified
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Z-1874-2024 · Root cause: Employee error · Recall details · FDA record ↗
Most reported Prelude Roadster problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Prelude Roadster models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prelude Roadster™ 00884450770757Introducer, catheter2 recalls0 reports
- Prelude Roadster™ 00884450770771Introducer, catheter2 recalls0 reports
- Prelude Roadster™ 00884450531969Introducer, catheter1 recall1 report
- Prelude Roadster™ 00884450531709Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450531716Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450531730Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450531914DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Prelude Roadster™ 00884450531921Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450531945Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450531952Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532065Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532133Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532140Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450532157Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532164Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532171Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532300Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450532317Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532324Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450532348Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532515Introducer, Catheter1 recall0 reports
- Prelude Roadster™ 00884450532522Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450532539Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450532546Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450532553Introducer, Catheter1 recall0 reports
- Prelude Roadster™ 00884450532560Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450532577Introducer, Catheter1 recall0 reports
- Prelude Roadster™ 00884450532584Introducer, catheter1 recall0 reports
- Prelude Roadster™ 00884450532591Introducer, Catheter1 recall0 reports
- Prelude Roadster™ 00884450532607Introducer, Catheter1 recall0 reports
- Prelude Roadster™ 00884450557501Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450770764Dilator, Vessel, For Percutaneous Catheterization1 recall0 reports
- Prelude Roadster™ 00884450770788Introducer, catheter1 recall0 reports
Recent Prelude Roadster adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2022Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION PROCEDURE, THE TIP OF THE DILATOR DETACHED. DURING PREPARATION OF THE PRIMARY ACCESS SHEATH, THE SHEATH WAS MANUALLY CURVED BY CLINICAL STAFF WITH A 10CC SYRINGE, WITH THE DILATOR IN PLACE. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED CONTRALATERAL RETROGRADE RIGHT FEMORAL ARTERY ACCESS VIA THE "SELDINGER TECHNIQUE" WITH THE PRIMARY ACCESS SHEATH AND HAD NEGOTIATED THE PATIENT'S RIGHT ILIAC BIFURCATING CONDUIT CROSSING OVER THE ILIAC ARCH AND ACCESSING THE LEFT ANTEGRADE ILIAC CONDUIT OVER A STIFF ANGLED .035X260 GUIDEWIRE, UNDER FLUOROSCOPY. THE INTRODUCER WAS THEN REMOVED FROM THE SHEATH. AFTER REMOVAL, THE SUPPORTING CLINICAL STAFF NOTED THAT THE TIP LOOKED "BLUNTED" CAUSING THE ATTENDING CLINICIAN TO FURTHER INVESTIGATE THE INTRODUCER CONFIRMING THE TIP OF THE INTRODUCER HAD DETACHED. ADDITIONAL FLUOROSCOPY WAS NECESSARY AS THEY ATTEMPTED TO UNSUCCESSFULLY LOCATE THE DETACHED TIP WITHIN THE PATIENT'S ANATOMY. THE CLINICIAN THEN ATTACHED A 20CC SYRINGE TO THE HUB OF THE PRIMARY ACCESS SHEATH AND CONTINUOUSLY ASPIRATED WHILE REMOVING THE ACCESS SHEATH FROM THE PATIENT'S ANATOMY. THE CLINICIAN HELD PRESSURE WHILE THE PR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15685482 ↗
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
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
- HeartSpan5 models · 10 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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