CENTRIMAG® 34FR DRAINAGE (VENOUS) CANNULA KIT 201-50067Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640135140184), received between Oct 25, 2023 and Oct 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NURSE HEARD CHANGE IN BREATHING OF THE PATIENT AND UPON INVESTIGATION FOUND THE PATIENT TO BE PROFUSELY BLEEDING. AN ARREST CALL WAS PUT OUT. THE VENTRICULAR ASSIST DEVICE (VAD) LINE WAS DISCONNECTED AROUND THE ABDOMINAL AREA AND WAS RECONNECTED AT THE TIME, YET DIFFICULT TO ASSESS THE EXACT LOCATION OF DISCONNECTION. THERE WAS A POSSIBLE DISCONNECTION AT THE CANNULA OR AT THE CHANGEOUT CONNECTOR. THE PATIENT PASSED AWAY THE FOLLOWING DAY. THE DISCONNECTION SITE WAS BELIEVED TO BE THE LEFT VENTRICULAR ASSIST DEVICE DRAINAGE LINE SIDE, NEAR WHERE IT EXITS THE PATIENTS SKIN. IT WAS POSSIBLE THAT EITHER THE TUBING DISCONNECTED FROM THE CANNULA OR TUBING DISCONNECTED FROM THE CHANGEOUT CONNECTOR. THE CONNECTIONS WERE NOT SECURED WITH TIE BANDS. ATTEMPTS WERE MADE TO RESUSCITATE THE PATIENT USING OTHER MECHANICAL SUPPORT. AT THE TIME, THE ISSUE WAS NOT THOUGHT TO BE AN EQUIPMENT FAILURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18005804 ↗