Prelude Roadster™ 00884450531969Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450531969), received between Oct 27, 2022 and Oct 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, 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 ↗