RAP Femoral Venous Cannula 200-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00803622125805), received between Oct 7, 2019 and Apr 24, 2026 — classified as 4 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K052081); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Infusion or Flow Problem

  SORIN GROUP ITALIA RECEIVED A REPORT OF AIR INTAKE IN THE VENOUS LINE DURING READJUSTMENT OF A RAP FEMORAL VENOUS CANNULA. CANNULA WAS CLAMPED TO AVOID FURTHER AIR INGRESS, RESULTING IN LINE DAMAGE. THE EVENT OCCURRED DURING AN ECMO PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY. REPORTEDLY, IT IS UNDETERMINED IF THIS IS AN ACTUAL PRODUCT PROBLEM OR USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981276 ↗
• MalfunctionMar 13, 2026

  ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION] CANNULA READJUSTMENT. DURING CANNULA READJUSTMENT, AIR ENTERED THE LINE AND THE CANNULAS WERE CLAMPED CAUSING FURTHER DAMAGE TO THE LINE. IT HAS BEEN NOTED PERFUSION HAS HAD RECENT ISSUES WITH THESE CANNULAS LEAKING AT THE CONNECTION PORTS. PLEASE NOTE THAT IT IS UNDETERMINED IF THIS IS AN ACTUAL PRODUCT ISSUE OR USER ERROR. CANNULA DESCRIBED HAS BEEN RETURNED TO THE SALES REP FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589345 ↗
• MalfunctionNov 14, 2025Break; Break

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556328 ↗
• MalfunctionOct 7, 2019Disconnection; Disconnection

  LIVANOVA HAS RECEIVED A REPORT THAT, WHEN TAKING OUT THE CANNULA, THE SURGEON NOTICED THAT THE CANNULA HAD SEPARATED AND IT WAS DIFFICULT TO REMOVE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9160592 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052081. One submission often covers many models, so check the product and lot details in each record.

• Z-0076-2018 · Sep 28, 2017 · Terminated
  FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 m