BIO-MEDICUS® 96530-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994489975), received between Jul 21, 2017 and Jul 21, 2017 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K884129); 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 16, 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.

• InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION VIA USER FACILITY MEDWATCH THAT DURING THE NIGHT SHIFT, STAFF NOTED OOZING FROM THE CANNULA SITE; HOWEVER HEMOGLOBIN, HEMATOCRIT, AND ARTERIAL BLOOD GASES WERE WITHIN NORMAL LIMITS. THE ON-COMING NURSE NOTICED BLOOD AROUND THE PATIENT'S NECK AND PILLOW DURING ASSESSMENT. THE NURSE CALLED FOR ASSISTANCE AND NOTED THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CONSOLE ALARMED AND THE CIRCUIT WAS CLAMPED. THE CANNULA HAD BEEN SUTURED WITH THREE SUTURES, WHICH WERE STILL INTACT ON THE SKIN AND AROUND THE CANNULA, BUT THE CANNULA WAS PARTIALLY DISLODGED (IT HAD SLIPPED THROUGH THE SUTURES). THE CUSTOMER NOTED THAT FLOWS THROUGH THE CIRCUIT WERE RUNNING AT 4 L/MINUTE. THE SURGEON WAS AT THE PATIENT'S BEDSIDE WITHIN A FEW MINUTES. A NEW CANNULA SITE ACCESS WAS ESTABLISHED AND VENO-VENOUS (V-V) ECMO WAS RE-INITIATED. THE PATIENT RECEIVED A BLOOD TRANSFUSION TO ADDRESS THE BLOOD LOSS. THE PATIENT WAS IN CRITICAL CONDITION FOLLOWING THE EVENT AND LATER PASSED AWAY. ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT'S DEATH WAS NOT RELATED TO A MEDTRONIC PRODUCT.

  Patient problems: Blood Loss

  MAUDE report 6731823 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K884129. One submission often covers many models, so check the product and lot details in each record.

• Z-1929-2008 · May 9, 2008 · Terminated
  Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015