Prelude® 10884450602901Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450602901), received between Mar 15, 2023 and Oct 19, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERIPHERAL VASCULAR PROCEDURE, THE ACCESS SHEATH DETACHED WHEN ATTEMPTING TO DELIVER A PERIPHERAL STENT FOR DEPLOYMENT WITHIN THE PATIENT'S PERIPHERAL CONDUIT. AS A RESULT, IT WAS NECESSARY FOR THE PATIENT TO UNDERGO VASCULAR SURGICAL REMOVAL OF THE DETACHED FOREIGN BODY. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965413 ↗
• InjuryMar 15, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT A 6F ACCESS SHEATH WAS INSERTED INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY AND WAS BEING USED AS A DISTAL REPERFUSION CATHETER TO DIRECT BLOOD FLOW FROM THE ARTERIAL RETURN CANNULA OF AN EXTRACORPOREAL MEMBRANE OXYGENATION [ECMO] CIRCUIT BACK INTO THE PATIENT'S RIGHT LOWER LEG/PERIPHERY. APPROXIMATELY 24 HOURS AFTER THE INITIAL PLACEMENT, THE PLASTIC CONNECTOR OF THE SIDE ARM TUBING DETACHED. THE DEVICE WAS EMERGENTLY REMOVED BY THE SURGICAL TEAM, THE PATIENT WAS STABILIZED, AND A NEW SHEATH WAS SUCCESSFULLY PLACED. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545346 ↗
• InjuryMar 15, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT A 6F ACCESS SHEATH WAS INSERTED INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY AND WAS BEING USED AS A DISTAL REPERFUSION CATHETER TO DIRECT BLOOD FLOW FROM THE ARTERIAL RETURN CANNULA OF AN EXTRACORPOREAL MEMBRANE OXYGENATION [ECMO] CIRCUIT BACK INTO THE PATIENT'S RIGHT LOWER LEG/PERIPHERY. APPROXIMATELY 18 HOURS AFTER THE INITIAL SHEATH PLACEMENT, THE PLASTIC CONNECTOR OF THE SIDE ARM TUBING DETACHED. THE DEVICE WAS EMERGENTLY REMOVED BY THE SURGICAL TEAM, THE PATIENT WAS STABILIZED, AND A NEW SHEATH WAS SUCCESSFULLY PLACED. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545339 ↗